Trial · NCT01020474
Adolescent Fibromyalgia Study
NCT01020474, Phase 4, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2015-06-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Adolescent Fibromyalgia Study. Trials, record NCT01020474. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01020474
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adolescent Fibromyalgia Study
- NCT number
- NCT01020474
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 107 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Fibromyalgia
- Interventions
- placebo, pregabalin (Lyrica)
- First posted
- 2009-11-25
- Last updated
- 2021-01-28
- Other registries' IDs
- eudract:2010-019521-34
- Results first posted
- 2015-06-25
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 15 in Mean Pain Diary Score | Week 15 | The Primary Endpoint is based on the daily pain diary, and is defined as change from baseline to Week 15 in mean pain diary score. The daily pain diary consists of an 11-point numeric rating scale ranging from zero (no pain) to 10 (worst possible pain). The patients rate their pain during the past 24 hours by choosing the appropriate number between 0 ("no pain") and 10 ("worst possible pain"). |
| Secondary | Change From Baseline to Week 15 in Mean Sleep Quality Diary Score | Week 15 | Change from Baseline to endpoint in mean sleep quality score from the daily sleep diary, defined as the mean of the last 7 diary entries prior to Visit 10 in the study while the participant is on study medication. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates "best possible sleep" and 10 indicates "worst possible sleep". |
| Secondary | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Baseline to Week 15 | Mean pain score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). For each week, only days up to the last day on study medication were considered. A minimum of 4 pain diaries were required to calculate the mean pain score. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). |
| Secondary | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Baseline to Week 15 | Mean sleep quality score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). A minimum of 4 sleep diaries are required to calculate the mean pain score. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates "best possible sleep" and 10 indicates "worst possible sleep". |
| Secondary | Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period) | Week 15 | The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater degree of impairment. Participants choose the number that best describes the pain during the last week. |
| Secondary | Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15 | Week 15 | At each visit, participants with at least 30% reduction from Baseline in mean pain score were defined as a 30% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). |
| Secondary | Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15 | Week 15 | At each visit, participants with at least 50% reduction from Baseline in mean pain score were defined as a 50% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). |
| Secondary | Proportion of Patient Global Impression Change (PGIC) at Week 15 | Week 15 | Responder rates based on PGIC was derived and tabulated by treatment group. A responder was defined as a participant who reports much improved or very much improved. The PGIC is a patient-rated single item that measures patient's perception of change in their overall status since starting study medication on a scale ranging from 1 (very much improved) to 7 (very much worse). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 15 in Mean Pain Diary Score | Week 15 | The full analysis set (FAS) population consists of all randomized participants who received at least one dose of study medication. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 15 in Mean Sleep Quality Diary Score | Week 15 | The FAS population consists of all randomized participants who received at least one dose of study medication. Last observation carried forward (LOCF) for participants with missing Week 15 mean pain score, i.e., the endpoint mean pain score. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Baseline to Week 15 | The FAS population consists of all randomized participants who received at least one dose of study medication. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) | Baseline to Week 15 | The FAS population consists of all randomized participants who received at least one dose of study medication. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period) | Week 15 | The FAS population consists of all randomized participants who received at least one dose of study medication. Baseline observation carried forward (BOCF) for participants with missing Week 15 mean pain score. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15 | Week 15 | The FAS population consists of all randomized participants who received at least one dose of study medication. Modified baseline observation carried forward (mBOCF) for participants with missing Week 15 mean pain score. | percentage of participants | NUMBER |
| SECONDARY | Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15 | Week 15 | The FAS population consists of all randomized participants who received at least one dose of study medication. mBOCF for participants with missing Week 15 mean pain score. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Patient Global Impression Change (PGIC) at Week 15 | Week 15 | The FAS population consists of all randomized participants who received at least one dose of study medication. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group84
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 15 in Mean Pain Diary Score | Pregabalin | -1.60 | Standard Error 0.32 | Units on a scale | |
| Change From Baseline to Week 15 in Mean Pain Diary Score | Placebo | -0.94 | Standard Error 0.31 | Units on a scale | |
| Change From Baseline to Week 15 in Mean Sleep Quality Diary Score | Pregabalin | -1.13 | Standard Error 0.30 | Units on a scale | |
| Change From Baseline to Week 15 in Mean Sleep Quality Diary Score | Placebo | -0.94 | Standard Error 0.31 | Units on a scale | |
| Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Pregabalin | Week 1 (N= 52, 49) | -0.48 | Standard Error 0.25 | Units on a scale |
| Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Placebo | Week 1 (N= 52, 49) | -0.41 | Standard Error 0.26 | Units on a scale |
| Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Pregabalin | Week 2 (N= 54, 47) | -1.11 | Standard Error 0.25 | Units on a scale |
| Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Placebo | Week 2 (N= 54, 47) | -0.48 | Standard Error 0.26 | Units on a scale |
| Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Pregabalin | Week 3 (N= 52, 44) | -1.27 | Standard Error 0.25 | Units on a scale |
| Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) | Placebo | Week 3 (N= 52, 44) | -0.45 | Standard Error 0.26 | Units on a scale |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregabalin | 54 | |
| Overall Study | STARTED | Placebo | 53 | |
| Overall Study | COMPLETED | Pregabalin | 44 | |
| Overall Study | COMPLETED | Placebo | 36 | |
| Overall Study | NOT COMPLETED | Pregabalin | 10 | |
| Overall Study | NOT COMPLETED | Placebo | 17 |
Source ClinicalTrials.gov
Adverse events54
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 discomfort | Gastrointestinal disorders | Pregabalin | 1 | 54 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo | 3 | 53 | |
| other | Abdominal pain | Gastrointestinal disorders | Pregabalin | 3 | 54 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 53 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Pregabalin | 0 | 54 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 3 | 53 | |
| other | Dry mouth | Gastrointestinal disorders | Pregabalin | 2 | 54 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 3 | 53 | |
| other | Nausea | Gastrointestinal disorders | Pregabalin | 12 | 54 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 5 | 53 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Pregabalin | 33 | 54 |
| Total, other adverse events | Placebo | 27 | 53 |
| Total, serious adverse events | Pregabalin | 1 | 54 |
| Total, serious adverse events | Placebo | 0 | 53 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27475753 | 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 vs Placebo: serious adverse events |
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/NCT01020474
GET https://conductscience.org/api/trials/v1/NCT01020474/results?page=2