NCT01226667

Brief Summary

A 9-week randomized double-blind, multi-center study of 172 patients, who after 1 week baseline evaluation are randomized to either fixed dose pregabalin starting at 75 mg BID for one week and increased to 150 mg BID for 7 weeks or flexibly dosed pregabalin given BID (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4 weeks.It is proposed that use of flexible dosing combined with nightly dosing would have similar pain relief to fixed dosing, would improve adherence, would have less side effects and would be more likely to improve sleep.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
174

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

5 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

Study Start

First participant enrolled

July 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2010

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 22, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 31, 2012

Status Verified

July 1, 2012

Enrollment Period

2 years

First QC Date

October 1, 2010

Last Update Submit

July 30, 2012

Conditions

Fibromyalgia

Keywords

fibromyalgialyricapregabalin

Outcome Measures

Primary Outcomes (1)

  • Pain score evaluation by NRS

    Least square mean change in Fibromyalgia pain at 8weeks compared to baseline utilizing an 11 point numerical rating scale daily pain diary (0 = no pain to 10 =worst possible pain) performed at daily awakening.

    8 weeks

Secondary Outcomes (3)

  • Patient Global Impression of Change

    At weeks 4 and 8

  • Discontinuation rate

    9 weeks

  • Improvements in Wolfe Symptom Severity Score

    9 weeks

Study Arms (2)

Flexible Dose

ACTIVE COMPARATOR

flexibly dosed pregabalin given BID (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4 weeks

Drug: Pregabalin

Fixed Dosing

ACTIVE COMPARATOR

75 mg BID for one week and increased to 150 mg BID for 7 weeks

Drug: Pregabalin

Interventions

PregabalinDRUG

Fixed dosing of pregabalin: Week 1: 75 mg bid. Weeks 2 - 8: 150 mg bid. Week 9 (Days 57-60 and Days 61-63): 75 mg bid. Flexible dosing of pregabalin: Week 1: placebo in the AM and 75 mg nightly; Week 2: placebo in the AM and 150 mg nightly.; Week 3 placebo in the a.m., 225 mg nightly; Weeks 4 - 8 placebo in the a.m., 300 mg nightly. Week 9 (Days 57-60) placebo in the a.m,, 150 mg bid nightly and Days 61-63: placebo in the a.m., and 75 mg bid nightly.

Fixed DosingFlexible Dose

Eligibility Criteria

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

You may qualify if:

  • diagnosis of fibromyalgia by ACR criteria
  • ambulatory patients
  • complete of 5 pain diaries during 1 week evaluation

You may not qualify if:

  • pregnant or of childbearing potential not using contraceptives
  • use of pregabalin in the past
  • concomitant use of opioids or gabapentin
  • estimated creatinine clearance less than 60
  • other criteria may apply

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

David Silver MD Inc

Beverly Hills, California, 90211, United States

Location

Stuart L Silverman MD Inc.

Beverly Hills, California, 90211, United States

Location

Talbert Medical Group

Huntington Beach, California, 92646, United States

Location

Catalina Pointe Clinial Research

Tucson, California, 85704, United States

Location

Affilaites in Medical Specialty

West Hills, California, 91307, United States

Location

Related Publications (1)

  • Nasser K, Kivitz AJ, Maricic MJ, Silver DS, Silverman SL. Twice daily versus once nightly dosing of pregabalin for fibromyalgia: a double-blind randomized clinical trial of efficacy and safety. Arthritis Care Res (Hoboken). 2014 Feb;66(2):293-300. doi: 10.1002/acr.22111.

    PMID: 23983064DERIVED

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

Study Officials

  • Keaton Nasser

    Osteoporosis Medical Center

    STUDY DIRECTOR

  • Stuart L Silverman, M.D.

    Osteoporosis Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2010

First Posted

October 22, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 31, 2012

Record last verified: 2012-07

Locations

US(5)