Trial · NCT01773993
Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)
NCT01773993, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2019-05-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan). Trials, record NCT01773993. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01773993
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)
- NCT number
- NCT01773993
- Status
- Completed
- Enrollment
- 534 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Pain Associated With Fibromyalgia
- Interventions
- Pregabalin
- First posted
- 2013-01-23
- Last updated
- 2023-10-10
- Results first posted
- 2019-05-03
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Adverse Drug Reaction | From Week 1 to 52 weeks at maximum | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. |
| Secondary | Percentage of Participants With Serious Adverse Drug Reaction | From Week 1 to52 weeks | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to LYRICA Capsules was assessed by the physician. |
| Secondary | Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert | From Week 1 to 52 weeks | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to LYRICA Capsules was assessed by the physician. |
| Secondary | Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events | From Week 1 to 52 weeks | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to peripheral edema or other edema-related events was evaluated. |
| Secondary | Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury | From Week 1 to 52 weeks | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to dizziness, somnolence, loss of consciousness, syncope, and potential for accidental injury was evaluated. |
| Secondary | Number of Participants With Adverse Drug Reactions Related to Vision-related Events | From Week 1 to 52 weeks | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to vision-related events was evaluated. |
| Secondary | Change From Baseline in Pain Score at Week 52 | Baseline and at Week 52 | The pain from fibromyalgia experienced during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no pain) to 10 (the most severe pain possible). Mean change from baseline in the pain score at Week 52 was presented along with standard deviation. |
| Secondary | Change From Baseline in Quality of Sleep Score at Week 52 | Baseline and at Week 52 | The quality of sleep experienced during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (the best sleep possible) to 10 (the worst sleep possible). Mean change from baseline in quality of sleep score at Week 52 was presented along with standard deviation. |
| Secondary | Patient's Impression (PGIC) at Week 52 | At Week 52 | The patient's impression (patient global impression of change \[PGIC\]) at Week 52, as compared to the baseline condition (including the first day of treatment), was rated by participants on a 7-grade scale. |
| Secondary | Physician's Impression (CGIC) at Week 52 | At Week 52 | The physician's impression (clinical global impression of change \[CGIC\]) at Week 52, as compared to the baseline condition (including the first day of treatment), was rated by the physician on a 7-grade scale. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Adverse Drug Reaction | From Week 1 to 52 weeks at maximum | The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Serious Adverse Drug Reaction | From Week 1 to52 weeks | The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert | From Week 1 to 52 weeks | The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events | From Week 1 to 52 weeks | The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once. | Participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury | From Week 1 to 52 weeks | The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once. | Participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Drug Reactions Related to Vision-related Events | From Week 1 to 52 weeks | The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Pain Score at Week 52 | Baseline and at Week 52 | The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of pain score was available among the baseline analysis population. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Quality of Sleep Score at Week 52 | Baseline and at Week 52 | The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of quality of sleep score was available among the baseline analysis population. | Units on a scale | MEAN |
| SECONDARY | Patient's Impression (PGIC) at Week 52 | At Week 52 | The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of PGIC was available among the baseline analysis population. | Participants | NUMBER |
| SECONDARY | Physician's Impression (CGIC) at Week 52 | At Week 52 | The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of CGIC was available among the baseline analysis population. | Participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Adverse Drug Reaction | LYRICA Capsules (Pregabalin) | 25.45 | Percentage of Participants | ||
| Percentage of Participants With Serious Adverse Drug Reaction | LYRICA Capsules (Pregabalin) | 0.20 | Percentage of Participants | ||
| Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert | LYRICA Capsules (Pregabalin) | 3.41 | Percentage of Participants | ||
| Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events | LYRICA Capsules (Pregabalin) | 6 | Participants | ||
| Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury | LYRICA Capsules (Pregabalin) | 65 | Participants | ||
| Number of Participants With Adverse Drug Reactions Related to Vision-related Events | LYRICA Capsules (Pregabalin) | 5 | Participants | ||
| Change From Baseline in Pain Score at Week 52 | LYRICA Capsules (Pregabalin) | -2.4 | Standard Deviation 2.67 | Units on a scale | |
| Change From Baseline in Quality of Sleep Score at Week 52 | LYRICA Capsules (Pregabalin) | -1.4 | Standard Deviation 2.71 | Units on a scale | |
| Patient's Impression (PGIC) at Week 52 | LYRICA Capsules (Pregabalin) | Markedly improved | 34 | Participants | |
| Patient's Impression (PGIC) at Week 52 | LYRICA Capsules (Pregabalin) | Improved | 79 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LYRICA Capsules (Pregabalin) | 534 | |
| Overall Study | COMPLETED | LYRICA Capsules (Pregabalin) | 499 | |
| Overall Study | NOT COMPLETED | LYRICA Capsules (Pregabalin) | 35 |
Source ClinicalTrials.gov
Adverse events88
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 | Anaemia | Blood and lymphatic system disorders | LYRICA Capsules (Pregabalin) | 2 | 499 | |
| other | Palpitations | Cardiac disorders | LYRICA Capsules (Pregabalin) | 2 | 499 | |
| other | Meniere's disease | Ear and labyrinth disorders | LYRICA Capsules (Pregabalin) | 1 | 499 | |
| other | Vertigo | Ear and labyrinth disorders | LYRICA Capsules (Pregabalin) | 1 | 499 | |
| other | Hyperprolactinaemia | Endocrine disorders | LYRICA Capsules (Pregabalin) | 1 | 499 | |
| other | Foreign body sensation in eyes | Eye disorders | LYRICA Capsules (Pregabalin) | 1 | 499 | |
| other | Vision blurred | Eye disorders | LYRICA Capsules (Pregabalin) | 3 | 499 | |
| other | Visual acuity reduced | Eye disorders | LYRICA Capsules (Pregabalin) | 1 | 499 | |
| other | Abdominal discomfort | Gastrointestinal disorders | LYRICA Capsules (Pregabalin) | 4 | 499 | |
| other | Abdominal distension | Gastrointestinal disorders | LYRICA Capsules (Pregabalin) | 1 | 499 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LYRICA Capsules (Pregabalin) | 0 | 499 |
| Total, other adverse events | LYRICA Capsules (Pregabalin) | 152 | 499 |
| Total, serious adverse events | LYRICA Capsules (Pregabalin) | 4 | 499 |
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.
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