A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia

NCT00830128 | Completed Phase 3 Results

• 1 other identifier: A0081209
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 19

Brief Summary

This study will assess the safety and efficacy of the long-term use of pregabalin at doses up to 450 mg/day in patients with fibromyalgia who have completed 16 weeks of dosing in Study A0081208 (NCT00830167).

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.

  Up to 53 weeks

Secondary Outcomes (11)

• Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint

  Baseline, Week 52 or Study Discontinuation

• Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance at Endpoint

  Baseline, Week 52 or Study Discontinuation

• Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Snoring at Endpoint

  Baseline, Week 52 or Study Discontinuation

• Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Awaken Short of Breath or With a Headache at Endpoint

  Baseline, Week 52 or Study Discontinuation

• Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Adequacy at Endpoint

  Baseline, Week 52 or Study Discontinuation

Study Arms (1)

pregabalin (Lyrica)

EXPERIMENTAL

Drug: pregabalin (Lyrica)

Interventions

pregabalin (Lyrica) DRUG

Dosage: 300-450 mg/day (150-225 mg twice daily), oral administration, Treatment duration: 52 weeks

pregabalin (Lyrica)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081208; which was determined to be related to the study medication by the investigator or the sponsor.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (19)

Pfizer Investigational Site

Yotukaidou, Chiba, Japan

Location

Pfizer Investigational Site

Matuyama-si, Ehime, Japan

Location

Pfizer Investigational Site

Iiduka, Fukuoka, Japan

Location

Pfizer Investigational Site

Kobe, Hyōgo, Japan

Location

Pfizer Investigational Site

Mito, Ibaraki, Japan

Location

Pfizer Investigational Site

Morioka, Iwate, Japan

Location

Pfizer Investigational Site

Yokohama, Kanagawa, Japan

Location

Pfizer Investigational Site

Tsu, Mie-ken, Japan

Location

Pfizer Investigational Site

Sendai, Miyagi, Japan

Location

Pfizer Investigational Site

Hiki-gun, Saitama, Japan

Location

Pfizer Investigational Site

Saitama-shi, Saitama, Japan

Location

Pfizer Investigational Site

Shimotsuga-gun, Tochigi, Japan

Location

Pfizer Investigational Site

Chiyoda-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Itabashi-Ku, Tokyo, Japan

Location

Pfizer Investigational Site

Shinagawa-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Nagano, Japan

Location

Pfizer Investigational Site

Osaka, Japan

Location

Pfizer Investigational Site

Ōita, Japan

Location

Pfizer Investigational Site

Yokohama, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Fibromyalgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: January 27, 2009
• Study Start: July 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: January 25, 2021
• Results First Posted: February 14, 2012

Record last verified: 2012-04

Locations

JP (19)