Trial · NCT01271933
Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients
NCT01271933, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2018-09-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients. Trials, record NCT01271933. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01271933
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients
- NCT number
- NCT01271933
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 441 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Fibromyalgia
- Interventions
- pregabalin, placebo
- First posted
- 2011-01-07
- Last updated
- 2021-01-22
- Results first posted
- 2018-09-14
Source ClinicalTrials.gov
Registered outcomes56
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Double-Blind Phase: Time to Loss of Therapeutic Response (LTR) | Randomization to Week 19 | The time to loss of therapeutic response (LTR) is the time to loss of pain response (\<30% pain response relative to the single-blind (SB) baseline mean pain) or withdrawal due to lack of efficacy or adverse events (in the double blind phase). |
| Primary | Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event | Randomization to Week 19 | Participants who did not maintain at least 30% pain response during the DB phase relative to baseline or were discontinued during DB due to lack of efficacy or an adverse event were considered to have a loss of therapeutic response. |
| Secondary | Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6 | Baseline, Weeks 1, 2, 3, 4, 5, 6 | Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). |
| Secondary | Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 | Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 | Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). |
| Secondary | Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Double Blind Endpoint Visit | Baseline, Double blind endpoint visit (Week 19) | Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). |
| Secondary | Single-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 1, 2, 3, 4, 5, 6 | Baseline, Weeks 1, 2, 3, 4, 5, 6 | The tiredness assessment in the daily interactive voice response system (IVRS) diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired). |
| Secondary | Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 | Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 | The tiredness assessment in the daily IVRS diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired). |
| Secondary | Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Double Blind Endpoint Visit | Baseline, Double blind endpoint visit (Week 19) | The tiredness assessment in the daily IVRS diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired). |
| Secondary | Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 | Baseline, Weeks 1, 2, 3, 4, 5, 6 | The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. |
| Secondary | Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Number of Awakenings After Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 | Baseline, Weeks 1, 2, 3, 4, 5, 6 | The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 registered outcomesOutcomes56
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Double-Blind Phase: Time to Loss of Therapeutic Response (LTR) | Randomization to Week 19 | Full analysis set (FAS) included all participants randomized to the double blind phase who received at least one dose of study medication in the double blind phase. | Days | MEDIAN |
| PRIMARY | Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event | Randomization to Week 19 | FAS included all participants randomized to the double blind phase who received at least one dose of study medication in the double blind phase. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6 | Baseline, Weeks 1, 2, 3, 4, 5, 6 | Single-blind analysis set (SBAS) consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. | Units on a scale | MEAN |
| SECONDARY | Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 | Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 | Full analysis set (FAS) consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. | Units on a scale | MEAN |
| SECONDARY | Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Double Blind Endpoint Visit | Baseline, Double blind endpoint visit (Week 19) | FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Single-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 1, 2, 3, 4, 5, 6 | Baseline, Weeks 1, 2, 3, 4, 5, 6 | SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. | Units on a scale | MEAN |
| SECONDARY | Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 | Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 | FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. | Units on a scale | MEAN |
| SECONDARY | Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Double Blind Endpoint Visit | Baseline, Double blind endpoint visit (Week 19) | FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 | Baseline, Weeks 1, 2, 3, 4, 5, 6 | SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. | Minutes | MEAN |
| SECONDARY | Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Number of Awakenings After Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 | Baseline, Weeks 1, 2, 3, 4, 5, 6 | SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies participants who awakened after sleep. | Number of times the participant awakened | MEAN |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 outcomesResults by group531
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Double-Blind Phase: Time to Loss of Therapeutic Response (LTR) | Pregabalin (Double Blind Phase) | 58 | 95% Confidence Interval 45 to NA | Days | |
| Double-Blind Phase: Time to Loss of Therapeutic Response (LTR) | Placebo (Double Blind Phase) | 23 | 95% Confidence Interval 14 to 41 | Days | |
| Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event | Pregabalin (Double Blind Phase) | 34 | Participants | ||
| Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event | Placebo (Double Blind Phase) | 41 | Participants | ||
| Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6 | Pregabalin (Single Blind Phase) | Week 1 | -0.9 | Standard Deviation 1.17 | Units on a scale |
| Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6 | Pregabalin (Single Blind Phase) | Week 2 | -1.5 | Standard Deviation 1.51 | Units on a scale |
| Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6 | Pregabalin (Single Blind Phase) | Week 3 | -2.0 | Standard Deviation 1.85 | Units on a scale |
| Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6 | Pregabalin (Single Blind Phase) | Week 4 | -2.3 | Standard Deviation 2.01 | Units on a scale |
| Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6 | Pregabalin (Single Blind Phase) | Week 5 | -2.5 | Standard Deviation 2.00 | Units on a scale |
| Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6 | Pregabalin (Single Blind Phase) | Week 6 | -2.6 | Standard Deviation 2.13 | Units on a scale |
1 to 10 of 531Source ClinicalTrials.gov
See all 531 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Single-Blind Phase | STARTED | Pregabalin (Single Blind Phase) | 441 | |
| Single-Blind Phase | STARTED | Pregabalin (Double Blind Phase) | 0 | |
| Single-Blind Phase | STARTED | Placebo (Double Blind Phase) | 0 | |
| Single-Blind Phase | COMPLETED | Pregabalin (Single Blind Phase) | 320 | |
| Single-Blind Phase | COMPLETED | Pregabalin (Double Blind Phase) | 0 | |
| Single-Blind Phase | COMPLETED | Placebo (Double Blind Phase) | 0 | |
| Single-Blind Phase | NOT COMPLETED | Pregabalin (Single Blind Phase) | 121 | |
| Single-Blind Phase | NOT COMPLETED | Pregabalin (Double Blind Phase) | 0 | |
| Single-Blind Phase | NOT COMPLETED | Placebo (Double Blind Phase) | 0 | |
| Double-Blind Phase | STARTED | Pregabalin (Single Blind Phase) | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events837
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 | Thrombocytopenia | Blood and lymphatic system disorders | Pregabalin (Single Blind Phase) | 0 | 441 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pregabalin (Double Blind Phase) | 0 | 63 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo (Double Blind Phase) | 1 | 58 | |
| other | Neutropenia | Blood and lymphatic system disorders | Pregabalin (Single Blind Phase) | 1 | 441 | |
| other | Neutropenia | Blood and lymphatic system disorders | Pregabalin (Double Blind Phase) | 0 | 63 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo (Double Blind Phase) | 0 | 58 | |
| other | Palpitations | Cardiac disorders | Pregabalin (Single Blind Phase) | 5 | 441 | |
| other | Palpitations | Cardiac disorders | Pregabalin (Double Blind Phase) | 1 | 63 | |
| other | Palpitations | Cardiac disorders | Placebo (Double Blind Phase) | 0 | 58 | |
| other | Ear pain | Ear and labyrinth disorders | Pregabalin (Single Blind Phase) | 1 | 441 |
1 to 10 of 837Source ClinicalTrials.gov
See all 837 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin (Single Blind Phase) | ||
| Total, all-cause mortality | Pregabalin (Double Blind Phase) | ||
| Total, all-cause mortality | Placebo (Double Blind Phase) | ||
| Total, other adverse events | Pregabalin (Single Blind Phase) | 353 | 441 |
| Total, other adverse events | Pregabalin (Double Blind Phase) | 34 | 63 |
| Total, other adverse events | Placebo (Double Blind Phase) | 27 | 58 |
| Total, serious adverse events | Pregabalin (Single Blind Phase) | 5 | 441 |
| Total, serious adverse events | Pregabalin (Double Blind Phase) | 2 | 63 |
| Total, serious adverse events | Placebo (Double Blind Phase) | 0 | 58 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24867298 | 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 (Double Blind Phase) vs Placebo (Double Blind Phase): Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event |
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/NCT01271933
GET https://conductscience.org/api/trials/v1/NCT01271933/registered?page=2