Trial · NCT00346034

This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia

NCT00346034, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2009-03-13

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia. Trials, record NCT00346034. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00346034

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia
NCT number: NCT00346034
Status: Completed
Phases: Phase 3
Enrollment: 357 participants, actual
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions: Fibromyalgia
Interventions: Pregabalin
First posted: 2006-06-29
Last updated: 2021-01-22
Results first posted: 2009-03-13

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score	Week 4	Mean Change: Observation VAS score minus Baseline score. Pain VAS: 100 mm horizontal line to rate (score) pain from 0 "no pain" to 100 "worst possible pain". Baseline = value @ double-blind screening if randomized to pregabalin during double-blind or value @ last visit from double-blind if randomized to placebo during double-blind.
Primary	Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score	Week 12 (end of treatment)	Mean Change: Observation VAS score minus Baseline score. Pain VAS is a 100mm horizontal line used to rate (score) pain by subject from 0 "no pain" to 100 "worst possible pain". Baseline=value @ double-blind screening if randomized to pregabalin during double-blind OR value @ last visit from double-blind if randomized to placebo during double-blind.

Source ClinicalTrials.gov

Outcomes2

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 4 in Pain Visual Analog Scale (VAS) Score	Week 4	This will include all patients who have received at least one dose of study medication and had observations at both baseline and week 4.	mm	MEAN
PRIMARY	Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score	Week 12 (end of treatment)	This will include all patients who have received at least one dose of study medication and observations at both baseline and week 12.	mm	MEAN

Source ClinicalTrials.gov

Results by group2

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 4 in Pain Visual Analog Scale (VAS) Score	Pregabalin		-18.1	Standard Deviation 24.1	mm
Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score	Pregabalin		-20.1	Standard Deviation 26.8	mm

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pregabalin	357
Overall Study	COMPLETED	Pregabalin	300
Overall Study	NOT COMPLETED	Pregabalin	57

Source ClinicalTrials.gov

Adverse events22

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
other	Dizziness	Nervous system disorders	Pregabalin	85	357
other	Headache	Nervous system disorders	Pregabalin	33	357
other	Somnolence	Nervous system disorders	Pregabalin	30	357
other	Vertigo	Ear and labyrinth disorders	Pregabalin	12	357
other	Constipation	Gastrointestinal disorders	Pregabalin	15	357
other	Dry mouth	Gastrointestinal disorders	Pregabalin	14	357
other	Nausea	Gastrointestinal disorders	Pregabalin	21	357
other	Vomiting	Gastrointestinal disorders	Pregabalin	13	357
other	Fatigue	General disorders	Pregabalin	24	357
other	Oedema peripheral	General disorders	Pregabalin	12	357

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected
Total, all-cause mortality	Pregabalin
Total, other adverse events	Pregabalin	173
Total, serious adverse events	Pregabalin	6

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22503162	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00346034

GET https://conductscience.org/api/trials/v1/NCT00346034/events?page=2

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