Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT01466361
Collaborator
(none)
187
1
3
3
62.5
Study Details
Study Description
Brief Summary
This study is designed to evaluate the ability of a nicotine lozenge to relieve craving for a cigarette compared to a matched placebo (a placebo is like sugar pill and contains no active).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
187 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving
Study Start Date
:
Sep 1, 2010
Actual Primary Completion Date
:
Dec 1, 2010
Actual Study Completion Date
:
Dec 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Lower dose Nicotine lower dose nicotine lozenge |
Drug: Nicotine lower dose
lower dose nicotine lozenge
|
| Active Comparator: Higher dose Nicotine higher dose Nicotine lozenge |
Drug: Nicotine higher dose
higher dose nicotine lozenge
|
| Placebo Comparator: Placebo Placebo |
Drug: Placebo
placebo
|
Outcome Measures
Primary Outcome Measures
- Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers [Baseline, 1, 3, 5, 10 and 15 minutes post-treatment]
Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.
- Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers [Baseline, 3 minutes and 15 minutes post-treatment]
Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.
Secondary Outcome Measures
- Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group [Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm]
Responders were defined as participants with an increase of at least one point (on the 100 point VAS scale) from baseline prior to provoked craving paradigm (B1) to baseline post provoked craving paradigm (B2) on the average cravings score. Percentage of these responders was calculated to evaluate the provocation rate.
- Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [Baseline, 0 minute, 60 minutes and 5 days post treatment]
AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with study treatment/s. SAE was defined as any untoward medical occurrence that at any dose results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization results in disability/ incapacity; is a congenital anomaly/ birth defect.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Generally healthy smokers who smoke more than 5 cigarettes per day
-
Body mass index (BMI) within the range 19-35 kilogram (kg)/meter (m)^2
-
Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.
Exclusion Criteria:
-
Women who are pregnant or who have a positive urine pregnancy test.
-
Participants with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
-
Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
-
Prior Concomitant Medication: Treatment with enzyme altering agents (e.g. carbamazepine, phenytoin, cimetidine, sodium valporate) within 30 days of the craving provocation visit; Use of any prescription psychoactive medication (such as but not limited to antidepressants, antipsychotics, anxiolytics) within 14 days of the craving provocation visit; Participant has used an over-the-counter (OTC) medication such as antihistamines, sedating agents, or any compound that would have a sedating effect within 24 hours of the craving provocation visit; Current use of any nicotine replacement therapy.
-
Substance abuse: Recent history or current history (within the last 1 year) of alcohol or other substance abuse.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Los Angeles Clinical Trials | Burbank | California | United States | 91505 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01466361
Other Study ID Numbers:
- S7120994
First Posted:
Nov 6, 2011
Last Update Posted:
Aug 28, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were recruited at the clinical site. |
|---|---|
| Pre-assignment Detail | Participants who smoked more than 5 cigarettes per day were included in the study. Participants were stratified to treatments according to their smoking status: heavy smokers: smoking greater than 20 cigarettes per day and light smokers: smoking between 6 - 20 cigarettes per day. |
| Arm/Group Title | Nicotine Lozenge 4 Milligrams (mg) (Heavy Smokers Group) | Placebo Lozenge (Heavy Smokers Group) | Nicotine Lozenge 1.5mg (Light Smokers Group) | Placebo Lozenge (Light Smokers Group) |
|---|---|---|---|---|
| Arm/Group Description | Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route. | Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route. | Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route. | Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route. |
| Period Title: Overall Study | ||||
| STARTED | 52 | 34 | 60 | 41 |
| COMPLETED | 52 | 34 | 60 | 41 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Nicotine Lozenge 4 mg (Heavy Smokers Group) | Placebo Lozenge 1 (Heavy Smokers Group) | Nicotine Lozenge 1.5mg (Light Smokers Group) | Placebo Lozenge 2 (Light Smokers Group) | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route. | Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route. | Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route. | Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route. | Total of all reporting groups |
| Overall Participants | 52 | 34 | 60 | 41 | 187 |
| Age (Years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Years] |
45.1
(10.42)
|
45.9
(9.43)
|
43.9
(11.48)
|
45.0
(10.59)
|
45.0
(10.48)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
23
44.2%
|
16
47.1%
|
24
40%
|
21
51.2%
|
84
44.9%
|
| Male |
29
55.8%
|
18
52.9%
|
36
60%
|
20
48.8%
|
103
55.1%
|
| Nicotine cravings assessment baseline scores on a Visual Analogue scale (VAS) (Score on a scale) [Mean (Standard Deviation) ] | |||||
| Baseline score prior provoked craving paradigm(B1) |
68.3
(29.147)
|
69.54
(26.534)
|
70.00
(20.895)
|
62.3
(25.785)
|
67.5
(26.090)
|
| Baseline score post provoked craving paradigm (B2) |
76.03
(24.849)
|
78.39
(23.659)
|
76.96
(21.667)
|
69.1
(26.335)
|
75.1
(24.127)
|
Outcome Measures
| Title | Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers |
|---|---|
| Description | Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured. |
| Time Frame | Baseline, 1, 3, 5, 10 and 15 minutes post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat (ITT) population: All randomized participants with at least one cravings assessment measurement post dose were analyzed. No data was imputed in case of dropouts or missing data. |
| Arm/Group Title | Nicotine Lozenge 1.5mg (Light Smokers Group) | Placebo Lozenge 2 (Light Smokers Group) |
|---|---|---|
| Arm/Group Description | Participants smoking between 6-20 cigarettes/day, received a single dose of 1.5mg nicotine lozenge, through oral route. | Participants smoking between 6-20 cigarettes/day, received a single dose of placebo lozenge, through oral route. |
| Measure Participants | 60 | 41 |
| 1 minute |
-15.40
(2.439)
|
-8.17
(2.958)
|
| 3 minutes |
-24.42
(3.108)
|
-17.26
(3.770)
|
| 5 minutes |
-30.19
(3.257)
|
-23.86
(3.950)
|
| 10 minutes |
-35.33
(3.428)
|
-30.23
(4.158)
|
| 15 minutes |
-38.99
(3.689)
|
-33.99
(4.475)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Nicotine Lozenge 1.5mg (Light Smokers Group), Placebo Lozenge 2 (Light Smokers Group) |
|---|---|---|
| Comments | Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 1 minute post dosing. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0643 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean difference |
| Estimated Value | -7.23 | |
| Confidence Interval |
(2-Sided) 95% -14.89 to 0.44 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Treatment comparisons were made between nicotine 1.5mg lozenge and placebo lozenge at 5% significance level. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Nicotine Lozenge 1.5mg (Light Smokers Group), Placebo Lozenge 2 (Light Smokers Group) |
|---|---|---|
| Comments | Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 3 minute post dosing. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1489 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean difference |
| Estimated Value | -7.16 | |
| Confidence Interval |
(2-Sided) 95% -16.93 to 2.61 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Treatment comparisons were made between nicotine 1.5mg lozenge and placebo lozenge at 5% significance level. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Nicotine Lozenge 1.5mg (Light Smokers Group), Placebo Lozenge 2 (Light Smokers Group) |
|---|---|---|
| Comments | Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 5 minute post dosing. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2225 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean difference |
| Estimated Value | -6.33 | |
| Confidence Interval |
(2-Sided) 95% -16.56 to 3.90 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Nicotine Lozenge 1.5mg (Light Smokers Group), Placebo Lozenge 2 (Light Smokers Group) |
|---|---|---|
| Comments | Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 10 minutes post dosing. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3491 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean difference |
| Estimated Value | -5.11 | |
| Confidence Interval |
(2-Sided) 95% -15.87 to 5.66 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Nicotine Lozenge 1.5mg (Light Smokers Group), Placebo Lozenge 2 (Light Smokers Group) |
|---|---|---|
| Comments | Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 15 minutes post dosing. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3936 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean difference |
| Estimated Value | -5.00 | |
| Confidence Interval |
(2-Sided) 95% -16.60 to 6.59 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level. | |
| Title | Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers |
|---|---|
| Description | Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured. |
| Time Frame | Baseline, 3 minutes and 15 minutes post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population: All randomized participants who had at least one cravings assessment measurement post dose. |
| Arm/Group Title | Nicotine Lozenge 4mg (Heavy Smokers Group) | Placebo Lozenge 1 (Heavy Smokers Group) |
|---|---|---|
| Arm/Group Description | Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route. | Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route. |
| Measure Participants | 52 | 34 |
| 1 minute |
-16.82
(2.613)
|
-13.24
(3.232)
|
| 3 minutes |
-29.52
(3.124)
|
-19.82
(3.865)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Nicotine Lozenge 1.5mg (Light Smokers Group), Placebo Lozenge 2 (Light Smokers Group) |
|---|---|---|
| Comments | Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, at 1 minute post dosing. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3922 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean difference |
| Estimated Value | -3.58 | |
| Confidence Interval |
(2-Sided) 95% -11.85 to 4.70 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Treatment comparisons were made between 4mg nicotine lozenge and placebo lozenge at 5% significance level. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Nicotine Lozenge 1.5mg (Light Smokers Group), Placebo Lozenge 2 (Light Smokers Group) |
|---|---|---|
| Comments | Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 3 minutes post dosing. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0547 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square mean difference |
| Estimated Value | -9.70 | |
| Confidence Interval |
(2-Sided) 95% -19.59 to 0.20 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Treatment comparisons were made between 4mg nicotine lozenge and placebo lozenge at 5% significance level. | |
| Title | Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group |
|---|---|
| Description | Responders were defined as participants with an increase of at least one point (on the 100 point VAS scale) from baseline prior to provoked craving paradigm (B1) to baseline post provoked craving paradigm (B2) on the average cravings score. Percentage of these responders was calculated to evaluate the provocation rate. |
| Time Frame | Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Light Smokers Group | Heavy Smokers Group |
|---|---|---|
| Arm/Group Description | Participants smoking between 6-20 cigarettes per day at baseline and responded to nicotine craving provocative paradigm before treatment | Participants smoking more than 20 cigarettes per day at baseline and responded to nicotine craving provocative paradigm before treatment |
| Measure Participants | 101 | 86 |
| Number [percentage] |
77.2
|
75.6
|
| Title | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) |
|---|---|
| Description | AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with study treatment/s. SAE was defined as any untoward medical occurrence that at any dose results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization results in disability/ incapacity; is a congenital anomaly/ birth defect. |
| Time Frame | Baseline, 0 minute, 60 minutes and 5 days post treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: All randomized participants who received the study treatments were considered evaluable for safety. |
| Arm/Group Title | Nicotine Lozenge 4 mg (Heavy Smokers Group) | Placebo Lozenge 1 (Heavy Smokers Group) | Nicotine Lozenge 1.5mg (Light Smokers Group) | Placebo Lozenge 2 (Light Smokers Group) |
|---|---|---|---|---|
| Arm/Group Description | Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route. | Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route. | Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route. | Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route. |
| Measure Participants | 52 | 34 | 60 | 41 |
| AEs |
11
21.2%
|
0
0%
|
1
1.7%
|
1
2.4%
|
| SAE |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | All AEs encountered or spontaneously reported following administration of any study treatment, and up to 5 days after the last administration of study treatment were recorded. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Nicotine Lozenge 1.5mg (Light Smokers Group) | Nicotine Lozenge 4mg (Heavy Smokers Group) | Placebo Lozenge 1 (Heavy Smokers Group) | Placebo Lozenge 2 (Light Smokers Group) | ||||
| Arm/Group Description | Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route. | Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route. | Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route. | Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route. | ||||
All Cause Mortality |
||||||||
| Nicotine Lozenge 1.5mg (Light Smokers Group) | Nicotine Lozenge 4mg (Heavy Smokers Group) | Placebo Lozenge 1 (Heavy Smokers Group) | Placebo Lozenge 2 (Light Smokers Group) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Nicotine Lozenge 1.5mg (Light Smokers Group) | Nicotine Lozenge 4mg (Heavy Smokers Group) | Placebo Lozenge 1 (Heavy Smokers Group) | Placebo Lozenge 2 (Light Smokers Group) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/60 (0%) | 0/52 (0%) | 0/34 (0%) | 0/41 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Nicotine Lozenge 1.5mg (Light Smokers Group) | Nicotine Lozenge 4mg (Heavy Smokers Group) | Placebo Lozenge 1 (Heavy Smokers Group) | Placebo Lozenge 2 (Light Smokers Group) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/60 (1.7%) | 11/52 (21.2%) | 0/34 (0%) | 1/41 (2.4%) | ||||
| Gastrointestinal disorders | ||||||||
| Nausea | 0/60 (0%) | 0 | 5/52 (9.6%) | 7 | 0/34 (0%) | 0 | 0/41 (0%) | 0 |
| Oral discomfort | 0/60 (0%) | 0 | 1/52 (1.9%) | 1 | 0/34 (0%) | 0 | 0/41 (0%) | 0 |
| Retching | 0/60 (0%) | 0 | 1/52 (1.9%) | 1 | 0/34 (0%) | 0 | 0/41 (0%) | 0 |
| Nervous system disorders | ||||||||
| Headache | 0/60 (0%) | 0 | 1/52 (1.9%) | 1 | 0/34 (0%) | 0 | 0/41 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Hiccups | 0/60 (0%) | 0 | 6/52 (11.5%) | 6 | 0/34 (0%) | 0 | 0/41 (0%) | 0 |
| Throat Irritation | 0/60 (0%) | 0 | 2/52 (3.8%) | 2 | 0/34 (0%) | 0 | 1/41 (2.4%) | 1 |
| Cough | 1/60 (1.7%) | 1 | 0/52 (0%) | 0 | 0/34 (0%) | 0 | 0/41 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01466361
Other Study ID Numbers:
- S7120994
First Posted:
Nov 6, 2011
Last Update Posted:
Aug 28, 2019
Last Verified:
Aug 1, 2019