Study to Determine if a Reduction in Pain Can be Measured in Spinal Cord Injured Patients Using a New Study Design
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT00978341
Collaborator
(none)
15
4
2
20
3.8
0.2
Study Details
Study Description
Brief Summary
The study is designed to assess if spinal cord injury patients have reduced pain after taking either pregabalin or placebo in a cross over design. Patients had either pain at the level of their injury or below the level of their injury.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This methodology study was terminated on October 13, 2008 based on interim results for an exploratory, novel endpoint. The results of the primary analysis at the interim for N=12 patients showed results that generally favored pregabalin but were not statistically significant compared to placebo. Based on the estimated conditional power, this result is unlikely to change with full recruitment of N=24 patients and therefore the data monitoring committee recommended termination of the trial. The decision to terminate the trial was not based on any safety concerns.
Study Design
Study Type:
Interventional
Actual Enrollment
:
15 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
A Methodology Study to Assess the Ability of a Randomised, Double Blind, Placebo Controlled, Crossover Trial Design in Spinal Cord Injury Patients With Pain of Neuropathic Origin to Detect Improvement in Pain Endpoints Using Pregabalin as a Benchmark Compound
Study Start Date
:
Feb 1, 2007
Actual Primary Completion Date
:
Oct 1, 2008
Actual Study Completion Date
:
Oct 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pregabalin
|
Drug: Pregabalin
Pregabalin 150mg capsules BID for 7.5 days
|
| Other: Placebo
|
Drug: Placebo for pregabalin
Placebo capsules BID for 7.5 days
|
Outcome Measures
Primary Outcome Measures
- Present Pain Intensity Score [Day 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours (post-dose); Day 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours (post-dose)]
Present pain intensity score: 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain).
Secondary Outcome Measures
- Daily Pain Score [Predose: Daily from 7 days before Visit 2 (start of Intervention 1) until the morning of Visit 5 (end of Intervention 2)]
Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
- Dynamic Allodynia Area [Screening, Days 1 & 8: 0 (pre-dose) & 4 hours post-dose,]
Area of dynamic allodynia was assessed using a brush (SENSElab Brush 05; velocity approximately 20 millimeters per second [mm/s]) by stimulating along a pattern of 8 radial spokes. Stimulation was started from the non-painful perimetry. Subjects were asked to report change in sensation from non-painful to painful and the spot was marked onto the skin. The area of dynamic allodynia was determined from these 8 distances by calculating the area of an octagon (in centimeter squared [cm2]).
- Dynamic Allodynia Pain Score [Screening, Days 1 & 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, and 6 hours post-dose]
Five strokes (each approx. 6 centimeters [cm] long) were applied with a standardized brush (SENSELab Brush 05) across the painful site (and a control site) at a constant velocity (20 millimeters per second [mm/sec]). Pain in response to brush stimulation of the allodynic area was recorded using an 11-point numeric rating scale from 0 (no pain) to 10 (worst possible pain). Patients were asked to give a pain rating after each brush stroke. A painful sensation was considered as representing brush allodynia.
- Punctate Allodynia Area [Screening, Days 1 & 8: 0 (pre-dose) and 4 hours post-dose]
Area of punctate allodynia was determined using a von Frey filament (OptiHair2). Stimulation was started from the non-painful perimetry and repeated along a pattern of 8 radial spokes. With a movement along each spoke at steps of 5 millimeters (mm), the subjects reported sensation changes from non-painful to painful and the spot was marked on the skin. The area of punctate allodynia was determined from these 8 distances by calculating the area of an octagon (in square centimeter(s)[cm2]).
- Mechanical Pain Sensitivity Stimulus-Response Function [Screening, Days 1 & 8: 0 (pre-dose), & 2, 4, and 6 hours post-dose]
Mechanical pain sensitivity stimulus response function was assessed at the control and painful sites using calibrated von Frey monofilaments and the SENSElab brush. Seven different von Frey monofilaments (8 -512 milliNewtons [mN], force increases by a factor of two from filament to filament) and the brush were applied in a predetermined pseudo-random order. Pain rating for each stimulus: 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).
- Neuropathic Pain Symptom Inventory (NPSI) [Prior to morning dosing on Day 1 and prior to discharge on Day 8 for each period.]
NPSI: subject rated questionnaire to evaluate 5 dimensions of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia). Includes 10 descriptors ranging from 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each relevant dimension. Total score is calculated as the sum of scores of the 10 descriptors, range: 0-100. Higher score indicates greater intensity of pain.
- Pharmacokinetic Evaluations of Pregabalin [Day 1: 0 (pre-dose), 0.5, 1, 2, and 6 hours post-dose; Day 8: 0 (pre-dose), 1, 4, & 6 hours post-dose]
Pharmacokinetic (PK) results are not presented in this report due to early termination of the trial. Pregabalin PK was not measured as there was incomplete data to conduct pharmacokinetic/pharmacodynamic analyses.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
subjects who are outpatients or inpatients
-
written informed consent obtained (signed by the subject or the subject's legally acceptable representative)
-
traumatic spinal cord injury of at least 1 year duration with a nonprogressive, i.e., chronic, stage of at least 6 months duration
-
At-level neuropathic pain: spontaneous or evoked pain with neuropathic features (sharp, shooting, electric or burning pain sensation) in the region of sensory disturbance in a segmental pattern and located within two dermatomes above or below the level of spinal cord injury
-
Below-level neuropathic pain: spontaneous or evoked pain with neuropathic features (sharp, shooting, electric or burning pain sensation) in the region of sensory disturbance located at least three dermatomes below the level of spinal cord injury
Exclusion Criteria:
-
spinal cord injury (subjects with central pain and musculoskeletal pain must be able to make a distinction between the two)
-
subjects who have previously not responded to 300 mg/day pregabalin: a non-responder is defined as a subject who has a reduction in pain score of less than 30% from baseline
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Randwick | New South Wales | Australia | 2031 |
| 2 | Pfizer Investigational Site | St Leonards | New South Wales | Australia | 2065 |
| 3 | Pfizer Investigational Site | Warrawong | New South Wales | Australia | 2502 |
| 4 | Pfizer Investigational Site | Heidelberg | Victoria | Australia | 3084 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00978341
Other Study ID Numbers:
- A0081141
First Posted:
Sep 16, 2009
Last Update Posted:
Jan 25, 2021
Last Verified:
Jan 1, 2010
Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Subjects were enrolled at 4 study centers and participated in the study between 13 February 2007 and 01 October 2008. |
|---|---|
| Pre-assignment Detail | Subjects completed a 1-2 week screening period to determine eligibility criteria prior to enrollment. Of 24 subjects screened, 15 subjects were enrolled into the study and randomized. |
| Arm/Group Title | Pregabalin First Then Placebo | Placebo First Then Pregabalin |
|---|---|---|
| Arm/Group Description | First Intervention Pregabalin Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning. Second Intervention Placebo Days 1-7: twice a day (BID); Day 8: 1 dose in the morning. | First Intervention Placebo Days 1-7: twice a day (BID); Day 8: 1 dose in the morning. Second Intervention Pregabalin: Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning. |
| Period Title: First Intervention | ||
| STARTED | 8 | 7 |
| COMPLETED | 8 | 7 |
| NOT COMPLETED | 0 | 0 |
| Period Title: First Intervention | ||
| STARTED | 8 | 7 |
| COMPLETED | 7 | 7 |
| NOT COMPLETED | 1 | 0 |
| Period Title: First Intervention | ||
| STARTED | 7 | 7 |
| COMPLETED | 7 | 7 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | Pregabalin: Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning; and Placebo: Days 1-7: twice a day (BID); Day 8: 1 dose in the morning. |
| Overall Participants | 15 |
| Age, Customized (participants) [Number] | |
| 18-44 years |
5
33.3%
|
| 45-64 years |
7
46.7%
|
| >= 65 years |
3
20%
|
| Sex/Gender, Customized (gender) [Number] | |
| Female |
2
|
| Male |
13
|
Outcome Measures
| Title | Present Pain Intensity Score |
|---|---|
| Description | Present pain intensity score: 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain). |
| Time Frame | Day 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours (post-dose); Day 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours (post-dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): those subjects who completed both periods of the study. Combined results for At-level and Below-level neuropathic pain; At-level: located within 2 dermatomes above or below the level of spinal cord injury; Below-level: located at least 3 dermatomes below the level of spinal cord injury. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning. | Days 1-7: twice a day (BID); Day 8: 1 dose in the morning |
| Measure Participants | 15 | 14 |
| Day 1: pre-dose (n=15, 14) |
5.3
(2.76)
|
4.9
(2.91)
|
| Day 1: 0.5 hours post-dose (n=15, 14) |
5.1
(2.46)
|
4.6
(3.03)
|
| Day 1: 1 hours post-dose (n=15, 14) |
4.6
(2.82)
|
4.7
(2.55)
|
| Day 1: 2 hours post-dose (n=15, 14) |
4.3
(2.64)
|
4.7
(2.64)
|
| Day 1: 3 hours post-dose (n=15, 14) |
4.3
(2.82)
|
4.7
(2.73)
|
| Day 1: 4 hours post-dose (n=15, 14) |
4.1
(2.79)
|
4.6
(2.98)
|
| Day 1: 5 hours post-dose (n=15, 14) |
3.9
(3.01)
|
4.9
(3.02)
|
| Day 1: 6 hours post-dose (n=15, 14) |
3.9
(2.89)
|
5.1
(2.91)
|
| Day 1: 8 hours post-dose (n=15, 14) |
4.3
(2.91)
|
5.1
(2.57)
|
| Day 1: 10 hours post-dose (n=14, 14) |
4.1
(3.03)
|
5.3
(2.81)
|
| Day 1: 12 hours post-dose (n=14, 14) |
4.1
(3.17)
|
5.4
(2.68)
|
| Day 8: pre-dose (n=13, 14) |
4.7
(2.53)
|
5.4
(2.62)
|
| Day 8: 0.5 hours post-dose (n=13, 14) |
4.5
(2.33)
|
5.0
(2.57)
|
| Day 8: 1 hour post-dose (n=13, 14) |
4.0
(2.71)
|
4.9
(2.60)
|
| Day 8: 2 hours post-dose (n=13, 14) |
4.6
(2.50)
|
4.6
(2.38)
|
| Day 8: 3 hours post-dose (n=15, 14) |
4.9
(2.22)
|
4.7
(2.52)
|
| Day 8: 4 hours post-dose (n=15, 14) |
4.9
(2.28)
|
4.9
(2.53)
|
| Day 8: 5 hours post-dose (n=15, 14) |
4.8
(2.40)
|
4.9
(2.63)
|
| Day 8: 6 hours post-dose (n=15, 14) |
4.4
(2.38)
|
5.2
(2.72)
|
| Day 8: 8 hours post-dose (n=15, 13) |
4.7
(2.63)
|
5.3
(2.90)
|
| Day 8: 10 hours post-dose (n=15, 13) |
4.9
(2.37)
|
5.2
(2.85)
|
| Day 8: 12 hours post-dose (n=15, 13) |
4.7
(2.16)
|
5.2
(2.65)
|
| Day 8: 24 hours post-dose (n=15, 14) |
5.0
(2.36)
|
5.4
(2.71)
|
| Day 8: 36 hours post-dose (n=15, 13) |
6.1
(2.74)
|
5.7
(2.56)
|
| Day 8: 48 hours post-dose (n=15, 14) |
6.1
(2.31)
|
5.8
(2.81)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline), Day 1: 0.5 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6797 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.20 | |
| Confidence Interval |
() 95% -0.83 to 1.22 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.462 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline), Day 1: 1 hour post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4811 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.38 | |
| Confidence Interval |
() 95% -1.54 to 0.77 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.528 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline), Day 1: 2 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1693 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.67 | |
| Confidence Interval |
() 95% -1.67 to 0.33 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.454 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline) , Day 1: 3 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4034 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.45 | |
| Confidence Interval |
() 95% -1.78 to 0.87 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.487 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline), Day 1: 4 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1935 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.93 | |
| Confidence Interval |
() 95% -2.36 to 0.50 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.694 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline), Day 1: 5 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0694 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.36 | |
| Confidence Interval |
() 95% -2.83 to 0.12 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.715 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline), Day 1: 6 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0396 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.55 | |
| Confidence Interval |
() 95% -3.02 to -0.08 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.713 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline), Day 1: 8 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1531 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.51 | |
| Confidence Interval |
() 95% -1.25 to 0.24 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.319 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline), Day 1: 10 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0951 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.25 | |
| Confidence Interval |
() 95% -2.79 to 0.29 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.637 |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline), Day 1: 12 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0614 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.38 | |
| Confidence Interval |
() 95% -2.84 to 0.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.615 |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline), Day 8: pre-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1946 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.87 | |
| Confidence Interval |
() 95% -2.29 to 0.54 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.619 |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline), Day 8: 0.5 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2843 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.68 | |
| Confidence Interval |
() 95% -2.20 to 0.84 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.553 |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline), Day 8: 1 hour post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2150 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.05 | |
| Confidence Interval |
() 95% -2.75 to 0.65 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.820 |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline), Day 8: 2 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9601 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.01 | |
| Confidence Interval |
() 95% -0.44 to 0.42 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.189 |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including baseline), Day 8: 3 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8670 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.05 | |
| Confidence Interval |
() 95% -0.64 to 0.74 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.311 |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including baseline), Day 8: 4 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9024 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.05 | |
| Confidence Interval |
() 95% -0.94 to 0.84 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.393 |
|
| Estimation Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline), Day 8: 5 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9708 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.01 | |
| Confidence Interval |
() 95% -0.67 to 0.65 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.293 |
|
| Estimation Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline), Day 8: 6 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1078 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.71 | |
| Confidence Interval |
() 95% -1.62 to 0.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.395 |
|
| Estimation Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline), Day 8: 8 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4460 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.33 | |
| Confidence Interval |
() 95% -1.28 to 0.61 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.419 |
|
| Estimation Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline), Day 8: 10 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5266 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.26 | |
| Confidence Interval |
() 95% -1.13 to 0.62 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.394 |
|
| Estimation Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline), Day 8: 12 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0290 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.69 | |
| Confidence Interval |
() 95% -1.29 to -0.08 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.273 |
|
| Estimation Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline), Day 8: 24 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1830 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.78 | |
| Confidence Interval |
() 95% -2.01 to 0.45 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.531 |
|
| Estimation Comments | ||
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline), Day 8: 36 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9884 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.01 | |
| Confidence Interval |
() 95% -0.90 to 0.91 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.406 |
|
| Estimation Comments | ||
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline), Day 8: 48 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8082 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.09 | |
| Confidence Interval |
() 95% -0.87 to 0.69 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.354 |
|
| Estimation Comments | ||
| Title | Daily Pain Score |
|---|---|
| Description | Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). |
| Time Frame | Predose: Daily from 7 days before Visit 2 (start of Intervention 1) until the morning of Visit 5 (end of Intervention 2) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; Combined results for At-level and Below-level of spinal cord injury. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning. | Days 1-7: twice a day (BID); Day 8: 1 dose in the morning. |
| Measure Participants | 15 | 14 |
| Day 1 (n=15, 13) |
6.2
(1.78)
|
6.3
(2.06)
|
| Day 2 (n=15, 14) |
4.4
(2.67)
|
5.4
(2.47)
|
| Day 3 (n=15, 14) |
4.1
(2.49)
|
5.1
(2.35)
|
| Day 4 (n=15, 14) |
4.2
(2.51)
|
5.0
(2.35)
|
| Day 5 (n= 15, 14) |
4.5
(2.67)
|
5.1
(2.37)
|
| Day 6 (n=15, 14) |
3.7
(2.60)
|
4.9
(2.30)
|
| Day 7 (n=15, 14) |
4.0
(2.70)
|
4.9
(2.54)
|
| Day 8 (n=14, 14) |
4.0
(2.35)
|
5.6
(2.47)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including baseline); Day 2. Combined analysis: values for the two patient groups were analyzed together using ANOVA and/or mixed models. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2101 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.92 | |
| Confidence Interval |
() 95% -2.39 to 0.55 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.714 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including baseline); Day 3. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1065 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.04 | |
| Confidence Interval |
() 95% -2.33 to 0.24 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.623 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including baseline); Day 4. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0697 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.53 | |
| Confidence Interval |
() 95% -1.11 to 0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.254 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo; Day 5. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4589 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.49 | |
| Confidence Interval |
() 95% -1.83 to 0.85 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.650 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo; Day 6. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1326 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.16 | |
| Confidence Interval |
() 95% -2.69 to 0.38 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.742 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including baseline); Day 7. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2820 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.78 | |
| Confidence Interval |
() 95% -2.45 to 0.90 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.638 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including baseline); Day 8. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0108 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.33 | |
| Confidence Interval |
() 95% -2.21 to -0.44 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.356 |
|
| Estimation Comments | ||
| Title | Dynamic Allodynia Area |
|---|---|
| Description | Area of dynamic allodynia was assessed using a brush (SENSElab Brush 05; velocity approximately 20 millimeters per second [mm/s]) by stimulating along a pattern of 8 radial spokes. Stimulation was started from the non-painful perimetry. Subjects were asked to report change in sensation from non-painful to painful and the spot was marked onto the skin. The area of dynamic allodynia was determined from these 8 distances by calculating the area of an octagon (in centimeter squared [cm2]). |
| Time Frame | Screening, Days 1 & 8: 0 (pre-dose) & 4 hours post-dose, |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; Combined results for At-level and Below-level of spinal cord injury. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning. | Days 1-7: twice a day (BID); Day 8: 1 dose in the morning. |
| Measure Participants | 15 | 14 |
| Day 1: pre-dose (n=14, 14) |
95.8
(108.1)
|
81.6
(111.2)
|
| Day 1: 4 hours post-dose (n=15, 13) |
63.0
(78.54)
|
50.9
(78.64)
|
| Day 8: pre-dose (n=12, 14) |
48.4
(92.07)
|
68.4
(83.53)
|
| Day 8: 4 hours post-dose (n=15, 13) |
50.5
(83.72)
|
68.0
(91.41)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo; Day 1: 4 hours post-dose (including Baseline). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9068 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.26 | |
| Confidence Interval |
() 95% -41.78 to 37.27 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 19.060 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo; Day 8: pre-dose (including Baseline). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7807 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.52 | |
| Confidence Interval |
() 95% -30.53 to 39.57 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 15.813 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo; Day 8: 4 hours post-dose (including Baseline). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2293 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -22.51 | |
| Confidence Interval |
() 95% -61.79 to 16.78 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 17.526 |
|
| Estimation Comments | ||
| Title | Dynamic Allodynia Pain Score |
|---|---|
| Description | Five strokes (each approx. 6 centimeters [cm] long) were applied with a standardized brush (SENSELab Brush 05) across the painful site (and a control site) at a constant velocity (20 millimeters per second [mm/sec]). Pain in response to brush stimulation of the allodynic area was recorded using an 11-point numeric rating scale from 0 (no pain) to 10 (worst possible pain). Patients were asked to give a pain rating after each brush stroke. A painful sensation was considered as representing brush allodynia. |
| Time Frame | Screening, Days 1 & 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, and 6 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; Combined results for At-level and Below-level of spinal cord injury. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning. | Days 1-7: twice a day (BID); Day 8: 1 dose in the morning. |
| Measure Participants | 15 | 14 |
| Day 1: pre-dose (n=14, 13) |
2.2
(2.99)
|
2.1
(3.33)
|
| Day 1: 0.5 hours post-dose (n=10, 8) |
2.8
(3.14)
|
1.9
(3.35)
|
| Day 1: 1 hour post-dose (n=10, 8) |
2.3
(2.83)
|
1.8
(3.15)
|
| Day 1: 2 hours post-dose (n=10, 8) |
2.5
(3.09)
|
1.7
(2.67)
|
| Day 1: 3 hours post-dose (n=10, 8) |
2.3
(2.94)
|
2.3
(2.98)
|
| Day 1: 4 hours post-dose (n=15, 13) |
1.5
(2.63)
|
1.2
(2.28)
|
| Day 1: 5 hours post-dose (n=10, 8) |
2.2
(2.95)
|
1.9
(2.70)
|
| Day 1: 6 hours post-dose (n=10, 8) |
2.1
(2.80)
|
1.9
(2.75)
|
| Day 8: pre-dose (n=11, 12) |
1.9
(2.93)
|
2.0
(2.97)
|
| Day 8: 0.5 hours post-dose (n=7, 8) |
1.7
(2.74)
|
1.7
(2.66)
|
| Day 8: 1 hour post-dose (n=7, 8) |
1.6
(2.66)
|
1.4
(2.58)
|
| Day 8: 2 hours post-dose (n=7, 8) |
1.9
(2.93)
|
1.5
(2.43)
|
| Day 8: 3 hours post-dose (n=9, 8) |
1.7
(2.45)
|
1.6
(2.51)
|
| Day 8: 4 hours post-dose (n=14, 13) |
1.0
(1.99)
|
0.9
(1.99)
|
| Day 8: 5 hours post-dose (n=9, 8) |
1.9
(2.83)
|
1.5
(2.40)
|
| Day 8: 6 hours post-dose (n=9, 8) |
1.9
(3.05)
|
1.5
(2.57)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 1: 0.5 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3774 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.36 | |
| Confidence Interval |
() 95% -0.54 to 1.27 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.386 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 1: 1 hour post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4153 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.19 | |
| Confidence Interval |
() 95% -0.33 to 0.70 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.215 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 1: 2 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1470 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.48 | |
| Confidence Interval |
() 95% -0.23 to 1.20 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 1: 3 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1862 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.45 | |
| Confidence Interval |
() 95% -1.18 to 0.29 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.300 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 1: 4 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8321 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.05 | |
| Confidence Interval |
() 95% -0.45 to 0.55 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.220 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 1: 5 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4251 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.23 | |
| Confidence Interval |
() 95% -0.42 to 0.88 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.269 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 1: 6 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6394 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.13 | |
| Confidence Interval |
() 95% -0.53 to 0.80 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.269 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 8: pre-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9964 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.00 | |
| Confidence Interval |
() 95% -0.68 to 0.68 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.302 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 8: 0.5 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3638 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.32 | |
| Confidence Interval |
() 95% -0.47 to 1.11 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.324 |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 8: 1 hour post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1202 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.42 | |
| Confidence Interval |
() 95% -0.15 to 0.99 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.223 |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 8: 2 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1204 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.60 | |
| Confidence Interval |
() 95% -0.19 to 1.39 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.355 |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 8: 3 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4213 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.25 | |
| Confidence Interval |
() 95% -0.44 to 0.93 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.289 |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 8: 4 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6028 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.11 | |
| Confidence Interval |
() 95% -0.34 to 0.56 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.205 |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 8: 5 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3624 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.48 | |
| Confidence Interval |
() 95% -0.68 to 1.64 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.491 |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 8: 6 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3163 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.48 | |
| Confidence Interval |
() 95% -0.52 to 1.49 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.461 |
|
| Estimation Comments | ||
| Title | Punctate Allodynia Area |
|---|---|
| Description | Area of punctate allodynia was determined using a von Frey filament (OptiHair2). Stimulation was started from the non-painful perimetry and repeated along a pattern of 8 radial spokes. With a movement along each spoke at steps of 5 millimeters (mm), the subjects reported sensation changes from non-painful to painful and the spot was marked on the skin. The area of punctate allodynia was determined from these 8 distances by calculating the area of an octagon (in square centimeter(s)[cm2]). |
| Time Frame | Screening, Days 1 & 8: 0 (pre-dose) and 4 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; combined results for At-level and Below-level spinal cord injury. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning. | Days 1-7: twice a day (BID); Day 8: 1 dose in the morning. |
| Measure Participants | 15 | 14 |
| Day 1: pre-dose (n=15, 14) |
75.6
(113.3)
|
65.1
(104.8)
|
| Day 1: 4 hours post-dose (n=15, 13) |
68.7
(112.6)
|
54.1
(91.21)
|
| Day 8: pre-dose (n=13, 14) |
53.1
(102.2)
|
45.9
(74.32)
|
| Day 8: 4 hours post-dose (n=15, 13) |
70.8
(106.3)
|
46.7
(80.73)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 1. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5919 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.39 | |
| Confidence Interval |
() 95% -16.26 to 27.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.738 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 8: pre-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3981 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 12.58 | |
| Confidence Interval |
() 95% -17.70 to 42.87 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 14.603 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 8: 4 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8314 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.64 | |
| Confidence Interval |
() 95% -24.00 to 29.28 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 12.123 |
|
| Estimation Comments | ||
| Title | Mechanical Pain Sensitivity Stimulus-Response Function |
|---|---|
| Description | Mechanical pain sensitivity stimulus response function was assessed at the control and painful sites using calibrated von Frey monofilaments and the SENSElab brush. Seven different von Frey monofilaments (8 -512 milliNewtons [mN], force increases by a factor of two from filament to filament) and the brush were applied in a predetermined pseudo-random order. Pain rating for each stimulus: 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). |
| Time Frame | Screening, Days 1 & 8: 0 (pre-dose), & 2, 4, and 6 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; combined results for At-level and Below-level of spinal cord injury. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning. | Days 1-7: twice a day (BID); Day 8: 1 dose in the morning. |
| Measure Participants | 14 | 14 |
| Day 1: pre-dose (n=14, 14) |
0.8
(0.78)
|
0.9
(0.73)
|
| Day 1: 2 hours post-dose (n=14, 14) |
0.7
(0.58)
|
0.8
(0.65)
|
| Day 1: 4 hours post-dose (n=14, 14) |
0.7
(0.64)
|
0.8
(0.65)
|
| Day 1: 6 hours post-dose (n=14, 14) |
0.8
(0.61)
|
0.9
(0.68)
|
| Day 8: pre-dose (n=13, 14) |
0.7
(0.61)
|
0.8
(0.64)
|
| Day 8: 2 hours post-dose (=13, 14) |
0.7
(0.50)
|
0.8
(0.66)
|
| Day 8: 4 hours post-dose (n=15, 13) |
0.7
(0.65)
|
0.7
(0.62)
|
| Day 8: 6 hours post-dose (n=15, 13) |
0.8
(0.67)
|
0.7
(0.59)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 1: 2 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7569 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.02 | |
| Confidence Interval |
() 95% -0.14 to 0.10 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.054 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 1: 4 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4814 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.07 | |
| Confidence Interval |
() 95% -0.26 to 0.13 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.090 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 1: 6 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6222 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.07 | |
| Confidence Interval |
() 95% -0.37 to 0.23 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.143 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 8: pre-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3035 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.12 | |
| Confidence Interval |
() 95% -0.35 to 0.12 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.113 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 8: 2 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1881 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.17 | |
| Confidence Interval |
() 95% -0.42 to 0.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.122 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 8: 4 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3159 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.08 | |
| Confidence Interval |
() 95% -0.09 to 0.24 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.072 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Difference from placebo (including Baseline); Day 8: 6 hours post-dose. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8203 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.02 | |
| Confidence Interval |
() 95% -0.22 to 0.27 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.103 |
|
| Estimation Comments | ||
| Title | Neuropathic Pain Symptom Inventory (NPSI) |
|---|---|
| Description | NPSI: subject rated questionnaire to evaluate 5 dimensions of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia). Includes 10 descriptors ranging from 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each relevant dimension. Total score is calculated as the sum of scores of the 10 descriptors, range: 0-100. Higher score indicates greater intensity of pain. |
| Time Frame | Prior to morning dosing on Day 1 and prior to discharge on Day 8 for each period. |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; Combined results for At-level and Below-level of spinal cord injury. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning. | Days 1-7: twice a day (BID); Day 8: 1 dose in the morning. |
| Measure Participants | 15 | 14 |
| Category 1 Day 1 (n=15, 14) |
6.0
|
6.0
|
| Category 1: Day 8 (n=12, 11) |
5.5
|
6.0
|
| Category 2: Day 1 (n=15, 14) |
3.0
|
2.5
|
| Category 2: Day 8 (n=12, 11) |
2.5
|
3.0
|
| Category 3: Day 1 (n=15, 14) |
1.5
|
3.3
|
| Category 3: Day 8 (n=12, 11) |
1.8
|
2.0
|
| Category 4: Day 1 (n=15, 14) |
1.7
|
0.3
|
| Category 4: Day 8 (n=12, 11) |
2.7
|
0.0
|
| Category 5: Day 1 (n=15, 14) |
5.0
|
5.0
|
| Category 5: Day 8 (n=12, 11) |
3.5
|
5.0
|
| Total: Day 1 (n=15, 14) |
32
|
27
|
| Total: Day 8 (n=12, 11) |
22
|
24
|
| Title | Pharmacokinetic Evaluations of Pregabalin |
|---|---|
| Description | Pharmacokinetic (PK) results are not presented in this report due to early termination of the trial. Pregabalin PK was not measured as there was incomplete data to conduct pharmacokinetic/pharmacodynamic analyses. |
| Time Frame | Day 1: 0 (pre-dose), 0.5, 1, 2, and 6 hours post-dose; Day 8: 0 (pre-dose), 1, 4, & 6 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Pregabalin | Placebo | ||
| Arm/Group Description | Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning. | Days 1-7: twice a day (BID); Day 8: 1 dose in the morning. | ||
All Cause Mortality |
||||
| Pregabalin | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Pregabalin | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/15 (0%) | 1/14 (7.1%) | ||
| Infections and infestations | ||||
| Urinary tract infection | 0/15 (0%) | 1/14 (7.1%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Pregabalin | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/15 (80%) | 9/14 (64.3%) | ||
| Cardiac disorders | ||||
| Palpitations | 1/15 (6.7%) | 0/14 (0%) | ||
| Congenital, familial and genetic disorders | ||||
| Dermoid cyst | 1/15 (6.7%) | 1/14 (7.1%) | ||
| Eye disorders | ||||
| Eye pain | 0/15 (0%) | 1/14 (7.1%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 1/15 (6.7%) | 0/14 (0%) | ||
| Dry mouth | 2/15 (13.3%) | 1/14 (7.1%) | ||
| Dyspepsia | 1/15 (6.7%) | 0/14 (0%) | ||
| Vomiting | 1/15 (6.7%) | 0/14 (0%) | ||
| General disorders | ||||
| Catheter related complication | 0/15 (0%) | 1/14 (7.1%) | ||
| Chest pain | 1/15 (6.7%) | 0/14 (0%) | ||
| Chills | 1/15 (6.7%) | 0/14 (0%) | ||
| Fatigue | 1/15 (6.7%) | 0/14 (0%) | ||
| Feeling drunk | 2/15 (13.3%) | 0/14 (0%) | ||
| Feeling hot | 1/15 (6.7%) | 1/14 (7.1%) | ||
| Oedema peripheral | 1/15 (6.7%) | 0/14 (0%) | ||
| Pyrexia | 2/15 (13.3%) | 0/14 (0%) | ||
| Infections and infestations | ||||
| Oral candidiasis | 0/15 (0%) | 1/14 (7.1%) | ||
| Urinary tract infection | 4/15 (26.7%) | 2/14 (14.3%) | ||
| Injury, poisoning and procedural complications | ||||
| Fall | 1/15 (6.7%) | 1/14 (7.1%) | ||
| Investigations | ||||
| Alanine aminotransferase increased | 1/15 (6.7%) | 0/14 (0%) | ||
| Aspartate aminotransferase increased | 1/15 (6.7%) | 0/14 (0%) | ||
| Urine analysis abnormal | 0/15 (0%) | 1/14 (7.1%) | ||
| Metabolism and nutrition disorders | ||||
| Hypocalcaemia | 0/15 (0%) | 1/14 (7.1%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Muscle spasms | 0/15 (0%) | 1/14 (7.1%) | ||
| Neck pain | 0/15 (0%) | 1/14 (7.1%) | ||
| Nervous system disorders | ||||
| Dizziness | 4/15 (26.7%) | 1/14 (7.1%) | ||
| Dizziness postural | 1/15 (6.7%) | 0/14 (0%) | ||
| Headache | 3/15 (20%) | 2/14 (14.3%) | ||
| Hypoaesthesia | 1/15 (6.7%) | 0/14 (0%) | ||
| Lethargy | 1/15 (6.7%) | 1/14 (7.1%) | ||
| Muscle spasticity | 1/15 (6.7%) | 0/14 (0%) | ||
| Neuralgia | 2/15 (13.3%) | 1/14 (7.1%) | ||
| Somnolence | 5/15 (33.3%) | 2/14 (14.3%) | ||
| Tension headache | 1/15 (6.7%) | 0/14 (0%) | ||
| Psychiatric disorders | ||||
| Euphoric mood | 1/15 (6.7%) | 0/14 (0%) | ||
| Renal and urinary disorders | ||||
| Stress urinary incontinence | 1/15 (6.7%) | 0/14 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Dermatitis | 0/15 (0%) | 1/14 (7.1%) | ||
Limitations/Caveats
This study was terminated prematurely.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.govCallCenter@pfizer.com |
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00978341
Other Study ID Numbers:
- A0081141
First Posted:
Sep 16, 2009
Last Update Posted:
Jan 25, 2021
Last Verified:
Jan 1, 2010