Trial · NCT01432236
A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression
NCT01432236, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2014-10-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression. Trials, record NCT01432236. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01432236
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression
- NCT number
- NCT01432236
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 197 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Fibromyalgia
- Interventions
- Pregabalin, placebo
- First posted
- 2011-09-12
- Last updated
- 2021-01-22
- Other registries' IDs
- eudract:2011-002480-19
- Results first posted
- 2014-10-22
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean NRS Pain Score at End of Period. | End of each period, at Weeks 6 and 14 | The daily pain diary consists of an 11-point numeric scale (NRS) ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The endpoint mean pain scores for Period 1 and Period 2 are defined as the mean of the last 7 non-missing daily diary pain ratings while taking study medication in the double-blind phase during Period 1 and Period 2, respectively. |
| Secondary | Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. | Baseline | This was a 20-item participant reported outcome instrument. It contained 10 subscales, which were combined to yield a total score. The first 11 questions were related specifically to physical functioning subscale, ranging from 0 to 10. The remaining 9 questions assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiety and depression ranging from 0 to 10. The higher values indicated greater impairment. All 20 were combined to form a total score ranging from 0 to 100, provides an estimation of fibromyalgia impact with higher scores indicating more impairment. The severity categorizations for the FIQ are: less than 40 (mild), 40-60 (moderate), and above 60 (severe). |
| Secondary | FIQ Score at End of Period. | End of each period, at Weeks 6 and 14 | This was a 20-item participant reported outcome instrument. It contained 10 subscales, which were combined to yield a total score. The first 11 questions were related specifically to physical functioning subscale, ranging from 0 to 10. The remaining 9 questions assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiety and depression ranging from 0 to 10. The higher values indicated greater impairment. All 20 were combined to form a total score ranging from 0 to 100, provides an estimation of fibromyalgia impact with higher scores indicating more impairment. The severity categorizations for the FIQ are: less than 40 (mild), 40-60 (moderate), and above 60 (severe). |
| Secondary | Patient Global Impression of Change (PGIC) at the End of Period 1. | End of Period 1 at Week 6 | PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). |
| Secondary | Percentage of Participants With >=30% and >=50% Pain Reduction Based on Daily Pain Diary. | Visits 2, 6, and 12 | Participant with at least a 30% reduction in mean pain score from baseline (at randomization) to the endpoint at the end of each period (Visits 6 and 12) is considered a 30% responder, for the respective period. Similarly, a subject with at least a 50% reduction in mean pain score from baseline (at randomization) to the endpoint at the end of each period (Visits 6 and 12) is considered a 50% responder, for the respective period. |
| Secondary | Subjective Sleep Questionnaire - Mean Sleep Quality at End of Period. | End of each period, at Weeks 6 and 14 | Subjective Sleep Questionnaire included 5 items: participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Subjective rating of quality of sleep during the past night was done by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses was therefore 0-10. |
| Secondary | Subjective Sleep Questionnaire - Mean Subjective Wake After Sleep Onset at End of Period. | End of each period, at Weeks 6 and 14 | Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective wake after sleep onset was the subjective estimate of the total amount of time the participant was awake after initial sleep onset until final awakening. |
| Secondary | Subjective Sleep Questionnaire - Mean Latency to Sleep Onset at End of Period. | End of each period, at Weeks 6 and 14 | Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective latency to sleep onset was the subjective estimate of the amount of time to fall asleep after lights out. |
| Secondary | Subjective Sleep Questionnaire - Mean Subjective Total Sleep Time at End of Period. | End of each period, at Weeks 6 and 14 | Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective total sleep time was the subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. |
| Secondary | Subjective Sleep Questionnaire - Parameter Estimates for Subjective Number of Awakenings Per Night After Sleep Onset at End of Period. | End of each period, at Weeks 6 and 14 | Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective number of awakenings after sleep onset was the subjective estimate of the total number of times the participant awakened during the night until final awakening. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean NRS Pain Score at End of Period. | End of each period, at Weeks 6 and 14 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. | Baseline | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Units on a scale | MEAN |
| SECONDARY | FIQ Score at End of Period. | End of each period, at Weeks 6 and 14 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. Different number (N) for each category represents participants that were actually treated with pregabalin and placebo during the study. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Global Impression of Change (PGIC) at the End of Period 1. | End of Period 1 at Week 6 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | PGIC at the End of Period 2. | End of Period 2 at Week 14 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With >=30% and >=50% Pain Reduction Based on Daily Pain Diary. | Visits 2, 6, and 12 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Percentage of participants | NUMBER |
| SECONDARY | Subjective Sleep Questionnaire - Mean Sleep Quality at End of Period. | End of each period, at Weeks 6 and 14 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Questionnaire - Mean Subjective Wake After Sleep Onset at End of Period. | End of each period, at Weeks 6 and 14 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Questionnaire - Mean Latency to Sleep Onset at End of Period. | End of each period, at Weeks 6 and 14 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Questionnaire - Mean Subjective Total Sleep Time at End of Period. | End of each period, at Weeks 6 and 14 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Minutes | LEAST_SQUARES_MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group160
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean NRS Pain Score at End of Period. | Pregabalin | 4.84 | Standard Error 0.15 | Units on a scale | |
| Mean NRS Pain Score at End of Period. | Placebo | 5.45 | Standard Error 0.16 | Units on a scale | |
| Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. | Pregabalin/Placebo | Total (N=96, 96) | 63.83 | Standard Deviation 11.58 | Units on a scale |
| Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. | Placebo/Pregabalin | Total (N=96, 96) | 62.75 | Standard Deviation 12.51 | Units on a scale |
| Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. | Pregabalin/Placebo | Physical Impairment (N=96, 97) | 4.58 | Standard Deviation 2.10 | Units on a scale |
| Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. | Placebo/Pregabalin | Physical Impairment (N=96, 97) | 4.44 | Standard Deviation 2.14 | Units on a scale |
| Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. | Pregabalin/Placebo | Feel Good (N=96, 97) | 7.78 | Standard Deviation 2.47 | Units on a scale |
| Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. | Placebo/Pregabalin | Feel Good (N=96, 97) | 7.43 | Standard Deviation 2.32 | Units on a scale |
| Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. | Pregabalin/Placebo | Work Missed (N=96, 97) | 3.38 | Standard Deviation 2.88 | Units on a scale |
| Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. | Placebo/Pregabalin | Work Missed (N=96, 97) | 3.49 | Standard Deviation 3.21 | Units on a scale |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregabalin/Placebo | 96 | |
| Overall Study | STARTED | Placebo/Pregabalin | 97 | |
| Overall Study | COMPLETED | Pregabalin/Placebo | 70 | |
| Overall Study | COMPLETED | Placebo/Pregabalin | 79 | |
| Overall Study | NOT COMPLETED | Pregabalin/Placebo | 26 | |
| Overall Study | NOT COMPLETED | Placebo/Pregabalin | 18 |
Source ClinicalTrials.gov
Adverse events396
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutrophilia | Blood and lymphatic system disorders | Pregabalin | 0 | 181 | |
| other | Neutrophilia | Blood and lymphatic system disorders | Placebo | 1 | 177 | |
| other | Palpitations | Cardiac disorders | Pregabalin | 0 | 181 | |
| other | Palpitations | Cardiac disorders | Placebo | 1 | 177 | |
| other | Ear pain | Ear and labyrinth disorders | Pregabalin | 0 | 181 | |
| other | Ear pain | Ear and labyrinth disorders | Placebo | 1 | 177 | |
| other | Tinnitus | Ear and labyrinth disorders | Pregabalin | 0 | 181 | |
| other | Tinnitus | Ear and labyrinth disorders | Placebo | 1 | 177 | |
| other | Vertigo | Ear and labyrinth disorders | Pregabalin | 2 | 181 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 0 | 177 |
1 to 10 of 396Source ClinicalTrials.gov
See all 396 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Pregabalin | 139 | 181 |
| Total, other adverse events | Placebo | 106 | 177 |
| Total, serious adverse events | Pregabalin | 3 | 181 |
| Total, serious adverse events | Placebo | 1 | 177 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pregabalin vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01432236
GET https://conductscience.org/api/trials/v1/NCT01432236/registered?page=2