Trial · NCT00830167
Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia
NCT00830167, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2012-06-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia. Trials, record NCT00830167. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00830167
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia
- NCT number
- NCT00830167
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 498 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Fibromyalgia
- Interventions
- Placebo, Pregabalin
- First posted
- 2009-01-27
- Last updated
- 2021-01-25
- Results first posted
- 2012-06-01
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline | Baseline, Week 15 or study discontinuation | Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale \<(NRS)-Pain\> ranging from 0 (no pain) to 10 (worst possible pain). |
| Secondary | Percentage of Participants Who Was Categorized as "Improved (Very Much Improved, Much Improved, or a Minimally Improved)" According to the Patient Global Impressions of Change (PGIC) | Week 15 or study discontinuation | PGIC was defined as 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). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse) , 6 (much worse) or 7 (very much worse) on the scale. |
| Secondary | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance | Baseline, Week 15 or study discontinuation | MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep disturbance. Change = mean scores at observation minus mean scores at baseline. |
| Secondary | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring | Baseline, Week 15 or study discontinuation | MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of snoring. Change = mean scores at observation minus mean scores at baseline. |
| Secondary | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache | Baseline, Week 15 or study discontinuation | MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of the symptom. Change = mean scores at observation minus mean scores at baseline. |
| Secondary | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep | Baseline, Week 15 or study discontinuation | MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score indicates greater quantity of sleep. Change = mean scores at observation minus mean scores at baseline. |
| Secondary | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy | Baseline, Week 15 or study discontinuation | MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep adequacy. Change = mean scores at observation minus mean scores at baseline. |
| Secondary | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence | Baseline, Week 15 or study discontinuation | MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of somnolence. Change = mean scores at observation minus mean scores at baseline. |
| Secondary | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index | Baseline, Week 15 or study discontinuation | MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of overall sleep problems. Change = mean scores at observation minus mean scores at baseline. |
| Secondary | Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint | Week 15 or study discontinuation | MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Optimal sleep was defined as sleep quantity of 7 or 8 hours per night. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Was Categorized as Improved (Very Much Improved, Much Improved, or a Minimally Improved) According to the Patient Global Impressions of Change (PGIC) | Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint | Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Participants | NUMBER |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline | Placebo | -1.03 | Standard Error 0.12 | Scores on a scale | |
| Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline | Pregabalin | -1.48 | Standard Error 0.12 | Scores on a scale | |
| Percentage of Participants Who Was Categorized as Improved (Very Much Improved, Much Improved, or a Minimally Improved) According to the Patient Global Impressions of Change (PGIC) | Placebo | 62.1 | Percentage of participants | ||
| Percentage of Participants Who Was Categorized as Improved (Very Much Improved, Much Improved, or a Minimally Improved) According to the Patient Global Impressions of Change (PGIC) | Pregabalin | 70.0 | Percentage of participants | ||
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance | Placebo | -8.13 | Standard Error 1.31 | Scores on a scale | |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance | Pregabalin | -17.62 | Standard Error 1.31 | Scores on a scale | |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring | Placebo | -1.61 | Standard Error 1.33 | Scores on a scale | |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring | Pregabalin | 3.37 | Standard Error 1.33 | Scores on a scale | |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache | Placebo | -3.02 | Standard Error 1.36 | Scores on a scale | |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache | Pregabalin | -8.01 | Standard Error 1.36 | Scores on a scale |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 248 | |
| Overall Study | STARTED | Pregabalin | 250 | |
| Overall Study | COMPLETED | Placebo | 208 | |
| Overall Study | COMPLETED | Pregabalin | 207 | |
| Overall Study | NOT COMPLETED | Placebo | 40 | |
| Overall Study | NOT COMPLETED | Pregabalin | 43 |
Source ClinicalTrials.gov
Adverse events20
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 | Vision blurred | Eye disorders | Placebo | 3 | 248 | |
| other | Vision blurred | Eye disorders | Pregabalin | 13 | 250 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 17 | 248 | |
| other | Constipation | Gastrointestinal disorders | Pregabalin | 36 | 250 | |
| other | Feeling abnormal | General disorders | Placebo | 3 | 248 | |
| other | Feeling abnormal | General disorders | Pregabalin | 20 | 250 | |
| other | Oedema peripheral | General disorders | Placebo | 3 | 248 | |
| other | Oedema peripheral | General disorders | Pregabalin | 18 | 250 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 45 | 248 | |
| other | Nasopharyngitis | Infections and infestations | Pregabalin | 45 | 250 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Pregabalin | ||
| Total, other adverse events | Placebo | 113 | 248 |
| Total, other adverse events | Pregabalin | 195 | 250 |
| Total, serious adverse events | Placebo | 0 | 248 |
| Total, serious adverse events | Pregabalin | 1 | 250 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pregabalin vs Placebo: Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint | Trial comparisons |
| Pregabalin vs Placebo: serious adverse events | 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/NCT00830167
GET https://conductscience.org/api/trials/v1/NCT00830167/registered?page=2