NI-PMS: Symptomatic Treatment Of Patients With Neuropathic Pain With LYRICA

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00843284
• Collaborator: (none)
• Enrollment: 691
• Duration (Months): 18

Study Details

Study Description

Brief Summary

A Non-Interventional, Post-Marketing Surveillance (NI-PMS) study whose objectives were to assess the impact of pregabalin on subjects' pain, quality of sleep, and their general wellbeing, as well as the tolerance and safety of pregabalin in subjects with neuropathic pain.

Condition or Disease	Intervention/Treatment	Phase
Neuropathic Pain	Drug: Pregabalin

Detailed Description

A non-interventional study of patients diagnosed with neuropathic pain administered pregabalin and followed up for 8 weeks

Study Design

• Study Type: Observational
• Actual Enrollment: 691 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Assessing the Treatment of Patients With Neuropathic Pain Using LYRICA; A Non Interventional Post-marketing Study (NI-PMS)
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Patients with neuropathic pain	Drug: Pregabalin; Capsules, 150 - 600 mg/day, 2-3 times/day, 8 weeks

Outcome Measures

Primary Outcome Measures

1. Daily Average Pain Scores [Baseline, Final Visit (Week 8 or discontinuation)]

   Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Daily average pain score is measured using a 10-point Likert scale where 0 = no pain to 10 = pain as bad as you can imagine.

2. Pain Related Sleep Interference [Baseline, Final Visit (Week 8 or discontinuation)]

   Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Pain related sleep interference is measured by a 10-point Likert scale where 0 = does not interfere with sleep, and 10 = completely interferes with sleep

Secondary Outcome Measures

1. Anxiety and Depression Symptoms [Baseline, Final Visit (Week 8 or discontinuation)]

   The presence of anxiety and depression symptoms were measured, based on how often the subject felt a certain emotion over the past week. Q1:Have you felt calm and relaxed? Q2: Have you felt full of energy? Q3: Have you felt discouraged and sad? Final Visit = Week 8 or time of discontinuation.

2. Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation) [Final Visit (Week 8 or discontinuation)]

   Clinician Global Improvement of Change (CGIC) indicates the change of the severity of the condition from baseline, graded from "very much improved" to "very much worse".

3. Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation) [Final Visit (Week 8 or discontinuation)]

   Patient Global Improvement of Change (PGIC) indicates the change of severity of conditions from baseline, graded from "very much improved" to "very much worse".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Clinical diagnosis of neuropathic pain and inclusion according to the current Summary of Product Characteristics.

Exclusion Criteria:

• The patients were excluded according to the current Summary of Product Characteristics.

Contacts and Locations

Locations

No locations specified.

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:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00843284
• Other Study ID Numbers: A0081139; ATLAS
• First Posted: Feb 13, 2009
• Last Update Posted: Feb 10, 2021
• Last Verified: Oct 1, 2009

• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: neuropathic, pain, pregabalin, Lyrica
• Additional relevant MeSH terms: Neuralgia; Pregabalin

Study Results

Participant Flow

Recruitment Details	The study was conducted at 23 sites in Greece by investigators contracted by and under the direction of the sponsor. This study was performed by office-based physicians and in hospitals.
Pre-assignment Detail	This study enrolled subjects with a confirmed diagnosis of neuropathic pain, according to the neuropathic pain diagnostic (DN4) Questionnaire, completed by the investigator at baseline

Arm/Group Title	Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
Arm/Group Description	275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
Period Title: Overall Study
STARTED	691
COMPLETED	619
NOT COMPLETED	72

Baseline Characteristics

Arm/Group Title	Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
Arm/Group Description	275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
Overall Participants	691
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.9 (13.7)
Sex/Gender, Customized (participants) [Number]
Female	434 62.8%
Male	254 36.8%
Unspecified	3 0.4%

Outcome Measures

1. Secondary Outcome

Title	Anxiety and Depression Symptoms
Description	The presence of anxiety and depression symptoms were measured, based on how often the subject felt a certain emotion over the past week. Q1:Have you felt calm and relaxed? Q2: Have you felt full of energy? Q3: Have you felt discouraged and sad? Final Visit = Week 8 or time of discontinuation.
Time Frame	Baseline, Final Visit (Week 8 or discontinuation)

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward method (LOCF) was used.

Arm/Group Title	Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
Arm/Group Description	275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
Measure Participants	668
Q1 at baseline: Always	8 1.2%
Q1 at baseline: Most of the time	14 2%
Q1 at baseline: Fairly often	57 8.2%
Q1 at baseline: Sometimes	199 28.8%
Q1 at baseline: Rarely	186 26.9%
Q1 at baseline: Never	183 26.5%
Q1 at baseline: Missing	0 0%
Q1 at baseline: Not done	21 3%
Q1 at final visit: Always	27 3.9%
Q1 at final visit: Most of the time	152 22%
Q1 at final visit: Fairly often	168 24.3%
Q1 at final visit: Sometimes	176 25.5%
Q1 at final visit: Rarely	72 10.4%
Q1 at final visit: Never	37 5.4%
Q1 at final visit: Missing	1 0.1%
Q1 at final visit: Not done	35 5.1%
Q2 at baseline: Always	5 0.7%
Q2 at baseline: Most of the time	15 2.2%
Q2 at baseline: Fairly often	62 9%
Q2 at baseline: Sometimes	150 21.7%
Q2 at baseline: Rarely	196 28.4%
Q2 at baseline: Never	219 31.7%
Q2 at baseline: Missing	0 0%
Q2 at baseline: Not done	21 3%
Q2 at final visit: Always	21 3%
Q2 at final visit: Most of the time	108 15.6%
Q2 at final visit: Fairly often	168 24.3%
Q2 at final visit: Sometimes	174 25.2%
Q2 at final visit: Rarely	102 14.8%
Q2 at final visit: Never	59 8.5%
Q2 at final visit: Missing	1 0.1%
Q2 at final visit: Not done	35 5.1%
Q3 at baseline: Always	48 6.9%
Q3 at baseline: Most of the time	167 24.2%
Q3 at baseline: Fairly often	190 27.5%
Q3 at baseline: Sometimes	143 20.7%
Q3 at baseline: Rarely	59 8.5%
Q3 at baseline: Never	40 5.8%
Q3 at baseline: Missing	0 0%
Q3 at baseline: Not done	21 3%
Q3 at final visit: Always	7 1%
Q3 final visit: Most of the time	37 5.4%
Q3 at final visit: Fairly often	73 10.6%
Q3 at final visit: Sometimes	179 25.9%
Q3 at final visit: Rarely	161 23.3%
Q3 at final visit: Never	175 25.3%
Q3 at final visit: Missing	1 0.1%
Q3 at final visit: Not done	35 5.1%

2. Primary Outcome

Title	Daily Average Pain Scores
Description	Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Daily average pain score is measured using a 10-point Likert scale where 0 = no pain to 10 = pain as bad as you can imagine.
Time Frame	Baseline, Final Visit (Week 8 or discontinuation)

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used.

Arm/Group Title	Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
Arm/Group Description	275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
Measure Participants	668
Baseline	7.61 (1.69)
Final visit (Week 8 or discontinuation)	3.46 (2.11)
Change from baseline	-4.16 (2.52)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
	Comments	Change from Baseline; observational study
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments	One sample t-test
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.16
	Confidence Interval	() 95%; -4.35 to -3.97
	Parameter Dispersion	Type: Standard Deviation; Value: 2.52
	Estimation Comments

3. Primary Outcome

Title	Pain Related Sleep Interference
Description	Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Pain related sleep interference is measured by a 10-point Likert scale where 0 = does not interfere with sleep, and 10 = completely interferes with sleep
Time Frame	Baseline, Final Visit (Week 8 or discontinuation)

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used.

Arm/Group Title	Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
Arm/Group Description	275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
Measure Participants	668
Baseline	6.28 (2.59)
Final visit (Week 8 or discontinuation)	2.27 (2.19)
Change from baseline	-4.02 (2.90)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
	Comments	Change from baseline
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments	One sample t-test.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.02
	Confidence Interval	() 95%; -4.24 to -3.80
	Parameter Dispersion	Type: Standard Deviation; Value: 2.90
	Estimation Comments

4. Secondary Outcome

Title	Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)
Description	Clinician Global Improvement of Change (CGIC) indicates the change of the severity of the condition from baseline, graded from "very much improved" to "very much worse".
Time Frame	Final Visit (Week 8 or discontinuation)

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used. Three subjects were not included in the analysis due to incomplete case report forms.

Arm/Group Title	Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
Arm/Group Description	275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
Measure Participants	665
Not assessed	0 0%
Very much improved	160 23.2%
Much improved	292 42.3%
Minimally improved	171 24.7%
No change	39 5.6%
Minimally worse	1 0.1%
Much worse	2 0.3%
Very much worse	0 0%
Not done	0 0%

5. Secondary Outcome

Title	Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)
Description	Patient Global Improvement of Change (PGIC) indicates the change of severity of conditions from baseline, graded from "very much improved" to "very much worse".
Time Frame	Final Visit (Week 8 or discontinuation)

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used.

Arm/Group Title	Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
Arm/Group Description	275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
Measure Participants	666
Not assessed	0 0%
Very much improved	175 25.3%
Much improved	245 35.5%
Minimally improved	193 27.9%
No change	44 6.4%
Minimally worse	7 1%
Much worse	2 0.3%
Very much worse	0 0%
Not done	0 0%

Adverse Events

Arm/Group Title	Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
Arm/Group Description	275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
All Cause Mortality
	Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
	Affected / at Risk (%)	# Events
Total	7/ (NaN)
Cardiac disorders
Cardiopulmonary failure	1/691 (0.1%)
Gastrointestinal disorders
Abdominal pain	1/691 (0.1%)
Nausea	1/691 (0.1%)
General disorders
Asthenia	1/691 (0.1%)
Death	3/691 (0.4%)
Fatigue	1/691 (0.1%)
Nervous system disorders
Tremor	1/691 (0.1%)
Psychiatric disorders
Dysphoria	1/691 (0.1%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	1/691 (0.1%)
Social circumstances
Walking disability	1/691 (0.1%)
Other (Not Including Serious) Adverse Events
	Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)
	Affected / at Risk (%)	# Events
Total	151/ (NaN)
Nervous system disorders
Dizziness	133/691 (19.2%)
Surgical and medical procedures
Somnolence	67/691 (9.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.