Trial · NCT00333866
Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin In Patients With Fibromyalgia.
NCT00333866, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2009-05-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin In Patients With Fibromyalgia. Trials, record NCT00333866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00333866
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin In Patients With Fibromyalgia.
- NCT number
- NCT00333866
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 747 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Fibromyalgia
- Interventions
- pregabalin, pregabalin, pregabalin, placebo
- First posted
- 2006-06-06
- Last updated
- 2021-02-11
- Results first posted
- 2009-05-13
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) | Baseline, Week 14 | Daily pain diary consists of 11-point NRS ranging from 0(no pain) to 10(worst possible pain). Participants rated their pain during past 24 hours, self-assessment done daily at awakening. Baseline=Last 7 available pain scores before taking study medication up to and including Day 1. Final weekly (endpoint) mean pain score is defined as the mean pain score from the last 7 pain diary entries in the study while the participant was on study medication. |
| Primary | Patient Global Impression of Change (PGIC) | Week 14 | Number of participants with categorical change in overall status. PGIC: a participant-rated instrument assessing change in participant's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse). |
| Secondary | Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14) | Baseline, Week 14 | Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The endpoint (up to week 14) mean quality of sleep score was based on Least Squares (LS) Means using ANCOVA, with treatment group and center in the model and the baseline mean sleep score used as the covariate. Final weekly (endpoint) mean sleep quality score is defined as the mean sleep quality score from the last 7 sleep diary entries in the study while the participant was on study medication. |
| Secondary | Change From Baseline in Weekly Mean Sleep Quality Score | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 | Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The weekly mean quality of sleep score was based on LS Means using mixed model repeated measures ANCOVA, with treatment, center, week, and treatment-by-week interaction in the model and the baseline mean sleep score used as the covariate. Weekly mean sleep quality score is defined as the mean of the last 7 daily sleep diary entries. |
| Secondary | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Baseline, Week 14 | Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range\*100);total score range:0-100,higher score=more disturbance. |
| Secondary | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Baseline, Week 14 | Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range\*100);total score range:0-100,higher score=more intensity of attribute. |
| Secondary | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | Baseline, Week 14 | FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment. |
| Secondary | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14 | Baseline, Week 14 | FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment. |
| Secondary | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Baseline, Week 14 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning. |
| Secondary | Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14 | Baseline, Week 14 | MAF is a 16-item self-administered questionnaire that yields a Global Fatigue Index (GFI), measures 4 dimensions of fatigue: degree and severity, amount of distress it causes, its timing and degree to which fatigue interferes with activities of daily living. Only 15 items are used to calculate the GFI. GFI score range from 1 (no fatigue) to 50 (severe fatigue). |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
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 Mean Pain Score at Endpoint (Up to Week 14) | Baseline, Week 14 | Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using last observation carried forward (LOCF) method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Patient Global Impression of Change (PGIC) | Week 14 | FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | participants | NUMBER |
| SECONDARY | Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14) | Baseline, Week 14 | FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Mean Sleep Quality Score | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 | FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n' participants evaluable at given time point for each group, respectively. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Baseline, Week 14 | FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were handled using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Baseline, Week 14 | FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were handled using LOCF method. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for specified category for each arm group. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | Baseline, Week 14 | FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n'=participants evaluable for specified category for each arm group, respectively. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14 | Baseline, Week 14 | FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Baseline, Week 14 | FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14 | Baseline, Week 14 | FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group232
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 Mean Pain Score at Endpoint (Up to Week 14) | Placebo | -0.73 | Standard Error 0.14 | Units on a scale | |
| Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) | Pregabalin 300 mg | -1.06 | Standard Error 0.14 | Units on a scale | |
| Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) | Pregabalin 450 mg | -1.29 | Standard Error 0.14 | Units on a scale | |
| Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) | Pregabalin 600 mg | -0.96 | Standard Error 0.14 | Units on a scale | |
| Patient Global Impression of Change (PGIC) | Placebo | Very much improved | 7 | participants | |
| Patient Global Impression of Change (PGIC) | Pregabalin 300 mg | Very much improved | 13 | participants | |
| Patient Global Impression of Change (PGIC) | Pregabalin 450 mg | Very much improved | 16 | participants | |
| Patient Global Impression of Change (PGIC) | Pregabalin 600 mg | Very much improved | 20 | participants | |
| Patient Global Impression of Change (PGIC) | Placebo | Much improved | 43 | participants | |
| Patient Global Impression of Change (PGIC) | Pregabalin 300 mg | Much improved | 45 | participants |
1 to 10 of 232Source ClinicalTrials.gov
See all 232 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 189 | |
| Overall Study | STARTED | Pregabalin 300 mg | 187 | |
| Overall Study | STARTED | Pregabalin 450 mg | 184 | |
| Overall Study | STARTED | Pregabalin 600 mg | 187 | |
| Overall Study | TREATED | Placebo | 184 | |
| Overall Study | TREATED | Pregabalin 300 mg | 184 | |
| Overall Study | TREATED | Pregabalin 450 mg | 182 | |
| Overall Study | TREATED | Pregabalin 600 mg | 186 | |
| Overall Study | COMPLETED | Placebo | 141 | |
| Overall Study | COMPLETED | Pregabalin 300 mg | 123 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events148
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 | Vertigo | Ear and labyrinth disorders | Placebo | 4 | 184 | |
| other | Vertigo | Ear and labyrinth disorders | Pregabalin 300 mg | 13 | 184 | |
| other | Vertigo | Ear and labyrinth disorders | Pregabalin 450 mg | 12 | 182 | |
| other | Vertigo | Ear and labyrinth disorders | Pregabalin 600 mg | 15 | 186 | |
| other | Vision blurred | Eye disorders | Placebo | 1 | 184 | |
| other | Vision blurred | Eye disorders | Pregabalin 300 mg | 6 | 184 | |
| other | Vision blurred | Eye disorders | Pregabalin 450 mg | 9 | 182 | |
| other | Vision blurred | Eye disorders | Pregabalin 600 mg | 13 | 186 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 8 | 184 | |
| other | Constipation | Gastrointestinal disorders | Pregabalin 300 mg | 18 | 184 |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Pregabalin 300 mg | ||
| Total, all-cause mortality | Pregabalin 450 mg | ||
| Total, all-cause mortality | Pregabalin 600 mg | ||
| Total, other adverse events | Placebo | 97 | 184 |
| Total, other adverse events | Pregabalin 300 mg | 137 | 184 |
| Total, other adverse events | Pregabalin 450 mg | 141 | 182 |
| Total, other adverse events | Pregabalin 600 mg | 154 | 186 |
| Total, serious adverse events | Placebo | 4 | 184 |
| Total, serious adverse events | Pregabalin 300 mg | 2 | 184 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00333866
GET https://conductscience.org/api/trials/v1/NCT00333866/results?page=2