Trial · NCT01387607
A Study For Pregabalin In Patients With Fibromyalgia
NCT01387607, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2018-07-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study For Pregabalin In Patients With Fibromyalgia. Trials, record NCT01387607. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01387607
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study For Pregabalin In Patients With Fibromyalgia
- NCT number
- NCT01387607
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 343 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Fibromyalgia
- Interventions
- pregabalin, placebo
- First posted
- 2011-07-04
- Last updated
- 2021-01-28
- Results first posted
- 2018-07-30
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14 | Baseline, Week 14 | Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. The endpoint mean pain score was defined as the mean of the Week 14 pain diary entries in the double-blind treatment phase. Baseline was defined as the mean of last 7 pain diary entries up to and including Day 1. |
| Secondary | Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Week 14 | The Patient Global Impression of Change (PGIC) was a participant-rated instrument that measured change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse), which was based on a validated scale, the Clinical Global Impression of Change (CGIC). Categories were defined based on the PGIC scores as followed: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse. |
| Secondary | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at Week 14 | Baseline, Week 14 | The Fibromyalgia Impact Questionnaire (FIQ) was a 20-item participant-reported outcome instrument designed to assess health status, progress, and outcomes in participants with fibromyalgia. It contained 10 subscales. There were 11 questions that are related specifically to physical functioning. The remaining items assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. Score range for each subscale was 0 to 10. The 10 subscales were combined to yield a total score with range from 0 to 100. The total score provided an estimation of fibromyalgia impact with higher scores indicating greater impairment. |
| Secondary | Percentage of Participants With at Least 30% Reduction in Weekly Mean Pain Score From Baseline to Week 14 | Baseline, Week 14 | Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. Weekly mean pain score was calculated as mean value of the observations within the window for each week during the double-blind treatment phase. A participant with at least 30% reduction in weekly mean pain score from baseline to Week 14 was defined as a 30% responder. |
| Secondary | Percentage of Participants With at Least 50% Reduction in Weekly Mean Pain Score From Baseline to Week 14 | Baseline, Week 14 | Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. Weekly mean pain score was calculated as mean value of the observations within the window for each week during the double-blind treatment phase. A participant with at least 50% reduction in weekly mean pain score from baseline to Week 14 was defined as a 50% responder. |
| Secondary | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Disturbance Subscale Score | Baseline, Week 14 | The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of scores represented for sleep disturbance was 0 to 100, with higher scores indicating more of the attribute. |
| Secondary | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores | Baseline, Week 14 | The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of scores represented for snoring, awaken short of breath and sleep adequacy was 0 to 100, with higher scores indicating more of the attribute. |
| Secondary | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Quantity of Sleep and Somnolence Subscale Scores | Baseline, Week 14 | The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of quantity of sleep parameter was 0 to 24 and somnolence was 0 to 100, with higher scores indicating more of the attribute. |
| Secondary | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Problems Index Overall Score | Baseline, Week 14 | The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of sleep problem index overall score was 0 to 100, with higher scores indicating more of the attribute. |
| Secondary | Percentage of Participants With Optimal Sleep at Week 14 in Medical Outcome Study (MOS)-Sleep Scale | Baseline, Week 14 | The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14 | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at Week 14 | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With at Least 30% Reduction in Weekly Mean Pain Score From Baseline to Week 14 | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least 50% Reduction in Weekly Mean Pain Score From Baseline to Week 14 | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Disturbance Subscale Score | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Quantity of Sleep and Somnolence Subscale Scores | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Problems Index Overall Score | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Optimal Sleep at Week 14 in Medical Outcome Study (MOS)-Sleep Scale | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Percentage of participants | NUMBER |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14 | Pregabalin | -2.01 | Standard Error 0.148 | Units on a scale | |
| Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14 | Placebo | -1.28 | Standard Error 0.150 | Units on a scale | |
| Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Pregabalin | Very much improved | 9.9 | Percentage of participants | |
| Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Placebo | Very much improved | 7.7 | Percentage of participants | |
| Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Pregabalin | Much improved | 25.4 | Percentage of participants | |
| Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Placebo | Much improved | 19.7 | Percentage of participants | |
| Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Pregabalin | Minimally improved | 40.1 | Percentage of participants | |
| Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Placebo | Minimally improved | 42.3 | Percentage of participants | |
| Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Pregabalin | No change | 17.6 | Percentage of participants | |
| Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Placebo | No change | 24.6 | Percentage of participants |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregabalin | 173 | |
| Overall Study | STARTED | Placebo | 170 | |
| Overall Study | Received Treatment | Pregabalin | 170 | |
| Overall Study | Received Treatment | Placebo | 164 | |
| Overall Study | COMPLETED | Pregabalin | 122 | |
| Overall Study | COMPLETED | Placebo | 125 | |
| Overall Study | NOT COMPLETED | Pregabalin | 51 | |
| Overall Study | NOT COMPLETED | Placebo | 45 |
Source ClinicalTrials.gov
Adverse events30
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 | Upper respiratory tract infection | Infections and infestations | Pregabalin | 10 | 170 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 7 | 164 | |
| other | Dizziness | Nervous system disorders | Pregabalin | 71 | 170 | |
| other | Dizziness | Nervous system disorders | Placebo | 30 | 164 | |
| other | Headache | Nervous system disorders | Pregabalin | 10 | 170 | |
| other | Headache | Nervous system disorders | Placebo | 10 | 164 | |
| other | Somnolence | Nervous system disorders | Pregabalin | 30 | 170 | |
| other | Somnolence | Nervous system disorders | Placebo | 13 | 164 | |
| serious | Atrial tachycardia | Cardiac disorders | Pregabalin | 0 | 170 | |
| serious | Atrial tachycardia | Cardiac disorders | Placebo | 1 | 164 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 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 | 88 | 170 |
| Total, other adverse events | Placebo | 47 | 164 |
| Total, serious adverse events | Pregabalin | 0 | 170 |
| Total, serious adverse events | Placebo | 9 | 164 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33658841 | DERIVED |
Source PubMed
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/NCT01387607
GET https://conductscience.org/api/trials/v1/NCT01387607/registered?page=2