Trial · NCT01020526
Pregabalin In Adolescent Patients With Fibromyalgia
NCT01020526, Phase 4, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2016-07-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pregabalin In Adolescent Patients With Fibromyalgia. Trials, record NCT01020526. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01020526
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pregabalin In Adolescent Patients With Fibromyalgia
- NCT number
- NCT01020526
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 63 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Fibromyalgia
- Interventions
- pregabalin
- First posted
- 2009-11-25
- Last updated
- 2021-01-28
- Other registries' IDs
- eudract:2010-020300-29
- Results first posted
- 2016-07-01
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Pain Numeric Rating Scale by Week | Baseline, Weeks 3, 8, 16, 24 and Last Visit. | 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 worse pain. Participants chose the number that best described the pain during the last week. Negative change indicates improvement. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Pain Numeric Rating Scale by Week | Baseline, Weeks 3, 8, 16, 24 and Last Visit. | This population will include all participants who have received at least one dose of study medication. | Number | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Pain Numeric Rating Scale by Week | Pregabalin | Baseline (N=63) | 6.7 | Standard Deviation 1.68 | Number |
| Change From Baseline in Pain Numeric Rating Scale by Week | Pregabalin | Week 3 (N=61) | -2.1 | Standard Deviation 2.51 | Number |
| Change From Baseline in Pain Numeric Rating Scale by Week | Pregabalin | Week 8 (N=55) | -1.8 | Standard Deviation 2.95 | Number |
| Change From Baseline in Pain Numeric Rating Scale by Week | Pregabalin | Week 16 (N=51) | -2.1 | Standard Deviation 2.6 | Number |
| Change From Baseline in Pain Numeric Rating Scale by Week | Pregabalin | Week 24 (N=55) | -2.1 | Standard Deviation 2.56 | Number |
| Change From Baseline in Pain Numeric Rating Scale by Week | Pregabalin | Last Visit (N=63) | -2.1 | Standard Deviation 2.47 | Number |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregabalin | 63 | |
| Overall Study | COMPLETED | Pregabalin | 49 | |
| Overall Study | NOT COMPLETED | Pregabalin | 14 |
Source ClinicalTrials.gov
Adverse events13
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 | Gastrointestinal disorders | Pregabalin | 5 | 63 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Pregabalin | 5 | 63 | |
| other | Nausea | Gastrointestinal disorders | Pregabalin | 5 | 63 | |
| other | Ear infection | Infections and infestations | Pregabalin | 4 | 63 | |
| other | Upper respiratory tract infection | Infections and infestations | Pregabalin | 4 | 63 | |
| other | Dizziness | Nervous system disorders | Pregabalin | 14 | 63 | |
| other | Headache | Nervous system disorders | Pregabalin | 6 | 63 | |
| other | Dysmenorrhoea | Reproductive system and breast disorders | Pregabalin | 3 | 53 | |
| other | Fatigue | General disorders | Pregabalin | 8 | 63 | |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | Pregabalin | 4 | 63 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 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 | 32 | 63 |
| Total, serious adverse events | Pregabalin | 3 | 63 |
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 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/NCT01020526
GET https://conductscience.org/api/trials/v1/NCT01020526/registered