Trial · NCT00830128
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia
NCT00830128, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2012-02-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia. Trials, record NCT00830128. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00830128
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia
- NCT number
- NCT00830128
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 106 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Fibromyalgia
- Interventions
- pregabalin (Lyrica)
- First posted
- 2009-01-27
- Last updated
- 2021-01-25
- Results first posted
- 2012-02-14
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 53 weeks | Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. |
| Secondary | Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint | Baseline, Week 52 or Study Discontinuation | The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit. Change = mean scores at observation minus mean scores at baseline. |
| Secondary | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance at Endpoint | Baseline, Week 52 or Study Discontinuation | MOS: patient 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 means greater sleep disturbance. Change = mean scores at observation minus mean scores at baseline. |
| Secondary | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Snoring at Endpoint | Baseline, Week 52 or Study Discontinuation | MOS: patient 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 means worse symptoms. Change = mean scores at observation minus mean scores at baseline. |
| Secondary | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Awaken Short of Breath or With a Headache at Endpoint | Baseline, Week 52 or Study Discontinuation | MOS: patient 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 means worse symptoms. Change = mean scores at observation minus mean scores at baseline. |
| Secondary | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Adequacy at Endpoint | Baseline, Week 52 or Study Discontinuation | MOS: patient 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 means greater sleep adequacy. Change = mean scores at observation minus mean scores at baseline. |
| Secondary | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Quantity of Sleep at Endpoint | Baseline, Week 52 or Study Discontinuation | MOS: patient 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 means 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 - Somnolence at Endpoint | Baseline, Week 52 or Study Discontinuation | MOS: patient 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 means worse symptoms. Change = mean scores at observation minus mean scores at baseline. |
| Secondary | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Overall Sleep Problems Index at Endpoint | Baseline, Week 52 or Study Discontinuation | MOS: patient 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 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 means worse symptoms. Change = mean scores at observation minus mean scores at baseline. |
| Secondary | Medical Outcomes Study (MOS) Sleep Scale - Optimal Sleep at Endpoint | Week 52 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. Number of participants with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is \< 7 hours per night. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 53 weeks | All participants who received at least 1 dose of the study medication. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint | Baseline, Week 52 or Study Discontinuation | All participants who have taken at least 1 dose of the study medication, regardless of compliance with the study medication, and have at least 1 postbaseline efficacy assessment. | mm | MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance at Endpoint | Baseline, Week 52 or Study Discontinuation | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Snoring at Endpoint | Baseline, Week 52 or Study Discontinuation | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Awaken Short of Breath or With a Headache at Endpoint | Baseline, Week 52 or Study Discontinuation | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Adequacy at Endpoint | Baseline, Week 52 or Study Discontinuation | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Quantity of Sleep at Endpoint | Baseline, Week 52 or Study Discontinuation | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | hours | MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Somnolence at Endpoint | Baseline, Week 52 or Study Discontinuation | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Overall Sleep Problems Index at Endpoint | Baseline, Week 52 or Study Discontinuation | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Units on a scale | MEAN |
| SECONDARY | Medical Outcomes Study (MOS) Sleep Scale - Optimal Sleep at Endpoint | Week 52 or Study Discontinuation | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Paticipants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Pregabalin | All-causality adverse events (AEs) | 102 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Pregabalin | All-causality SAEs | 3 | Participants | |
| Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint | Pregabalin | -13.1 | Standard Deviation 25.3 | mm | |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance at Endpoint | Pregabalin | -9.6 | Standard Deviation 23.3 | Units on a scale | |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Snoring at Endpoint | Pregabalin | 1.9 | Standard Deviation 22.3 | Units on a scale | |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Awaken Short of Breath or With a Headache at Endpoint | Pregabalin | -3.0 | Standard Deviation 23.1 | Units on a scale | |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Adequacy at Endpoint | Pregabalin | 4.2 | Standard Deviation 21.3 | Units on a scale | |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Quantity of Sleep at Endpoint | Pregabalin | 0.3 | Standard Deviation 1.2 | hours | |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Somnolence at Endpoint | Pregabalin | 7.2 | Standard Deviation 24.0 | Units on a scale | |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Overall Sleep Problems Index at Endpoint | Pregabalin | -3.7 | Standard Deviation 15.7 | Units on a scale |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregabalin | 106 | |
| Overall Study | COMPLETED | Pregabalin | 87 | |
| Overall Study | NOT COMPLETED | Pregabalin | 19 |
Source ClinicalTrials.gov
Adverse events18
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 | Abdominal pain upper | Gastrointestinal disorders | Pregabalin | 8 | 106 | |
| other | Constipation | Gastrointestinal disorders | Pregabalin | 23 | 106 | |
| other | Nausea | Gastrointestinal disorders | Pregabalin | 7 | 106 | |
| other | Oedema peripheral | General disorders | Pregabalin | 9 | 106 | |
| other | Nasopharyngitis | Infections and infestations | Pregabalin | 33 | 106 | |
| other | Fall | Injury, poisoning and procedural complications | Pregabalin | 6 | 106 | |
| other | Weight increased | Investigations | Pregabalin | 21 | 106 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Pregabalin | 6 | 106 | |
| other | Fibromyalgia | Musculoskeletal and connective tissue disorders | Pregabalin | 9 | 106 | |
| other | Osteoarthritis | Musculoskeletal and connective tissue disorders | Pregabalin | 8 | 106 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin | ||
| Total, other adverse events | Pregabalin | 92 | 106 |
| Total, serious adverse events | Pregabalin | 3 | 106 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00830128
GET https://conductscience.org/api/trials/v1/NCT00830128/results?page=2