NCT00830167

Brief Summary

This study, will compare pregabalin with placebo for the duration of 15 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
498

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 1, 2012

Completed
Last Updated

January 25, 2021

Status Verified

April 1, 2012

Enrollment Period

2.2 years

First QC Date

January 26, 2009

Results QC Date

April 30, 2012

Last Update Submit

January 21, 2021

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline

    Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale \<(NRS)-Pain\> ranging from 0 (no pain) to 10 (worst possible pain).

    Baseline, Week 15 or study discontinuation

Secondary Outcomes (32)

  • Percentage of Participants Who Was Categorized as "Improved (Very Much Improved, Much Improved, or a Minimally Improved)" According to the Patient Global Impressions of Change (PGIC)

    Week 15 or study discontinuation

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

    Baseline, Week 15 or study discontinuation

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

    Baseline, Week 15 or study discontinuation

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

    Baseline, Week 15 or study discontinuation

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

    Baseline, Week 15 or study discontinuation

  • +27 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Pregabalin

EXPERIMENTAL
Drug: Pregabalin

Interventions

PlaceboDRUG

Dosage: placebo, oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)

Placebo
PregabalinDRUG

Dosage: 300 or 450 mg/day (150 or 225 mg bid), oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)

Pregabalin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ACR criteria for fibromyalgia
  • A score of more or equal to 40 mm on the Pain VAS
  • An average score more or equal to 4 on 4 daily pain diaries

You may not qualify if:

  • Patients with other severe pain conditions
  • Patients with severe depression
  • Patients taking excluded medications
  • Patients with suicidality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Pfizer Investigational Site

Nagoya, Aichi-ken, Japan

Location

Pfizer Investigational Site

Ichihara-shi, Chiba, Japan

Location

Pfizer Investigational Site

Yotukaidou, Chiba, Japan

Location

Pfizer Investigational Site

Matuyama-si, Ehime, Japan

Location

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Location

Pfizer Investigational Site

Iiduka, Fukuoka, Japan

Location

Pfizer Investigational Site

Kitakyushu, Fukuoka, Japan

Location

Pfizer Investigational Site

Takasaki, Gunma, Japan

Location

Pfizer Investigational Site

Sapporo, Hokkaido, 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

Sagamihara-shi, Kanagawa, Japan

Location

Pfizer Investigational Site

Yokohama, Kanagawa, Japan

Location

Pfizer Investigational Site

Koushi, Kumamoto, 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, Saitama, Japan

Location

Pfizer Investigational Site

Saitama-shi, Saitama, Japan

Location

Pfizer Investigational Site

Aoi-ku, Shizuoka, Japan

Location

Pfizer Investigational Site

Shimotsuga-gun, Tochigi, Japan

Location

Pfizer Investigational Site

Bunkyo-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Chiyoda-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Chuou-Ku, Tokyo, Japan

Location

Pfizer Investigational Site

Itabashi-Ku, Tokyo, Japan

Location

Pfizer Investigational Site

Setagaya City, Tokyo, Japan

Location

Pfizer Investigational Site

Setagaya-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Shinagawa-Ku, Tokyo, Japan

Location

Pfizer Investigational Site

Toyama, Toyama, Japan

Location

Pfizer Investigational Site

Nagano, Japan

Location

Pfizer Investigational Site

Osaka, Japan

Location

Pfizer Investigational Site

Ōita, Japan

Location

Pfizer Investigational Site

Tokushima, Japan

Location

Pfizer Investigational Site

Yokohama, Japan

Location

Related Publications (2)

  • Clair A, Emir B. The safety and efficacy of pregabalin for treating subjects with fibromyalgia and moderate or severe baseline widespread pain. Curr Med Res Opin. 2016;32(3):601-9. doi: 10.1185/03007995.2015.1134463. Epub 2016 Jan 27.

    PMID: 26694975DERIVED

  • Ohta H, Oka H, Usui C, Ohkura M, Suzuki M, Nishioka K. A randomized, double-blind, multicenter, placebo-controlled phase III trial to evaluate the efficacy and safety of pregabalin in Japanese patients with fibromyalgia. Arthritis Res Ther. 2012 Oct 12;14(5):R217. doi: 10.1186/ar4056.

    PMID: 23062189DERIVED

Related Links

MeSH Terms

Conditions

Fibromyalgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino 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
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2009

First Posted

January 27, 2009

Study Start

March 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

January 25, 2021

Results First Posted

June 1, 2012

Record last verified: 2012-04

Locations

JP(35)