Study Evaluating the Efficacy of DVS-233 in Fibromyalgia

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Adaptive Design, Efficacy and Tolerability Study of 4 Fixed Doses of DVS-233 in Adult Outpatients With Fibromyalgia Syndrome

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00301431

Enrollment

1050

Registered

2006-03-10

Start date

2006-08-31

Completion date

2007-06-30

Last updated

2007-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Fibromyalgia, Adults, Outpatients, Adult, Double-Blind Method

Brief summary

The purpose of this study is to determine if DVS-233 is safe and effective in the treatment of pain and other symptoms of fibromyalgia syndrome.

Interventions

DRUGDVS-233

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Fibromyalgia according to 1990 American College of Rheumatology (ACR) criteria

Exclusion criteria

* Other painful conditions that may make results difficult to interpret. * Treatment with other drugs for fibromyalgia with 14 days of study start or during the study.

Design outcomes

Primary

Measure	Time frame
The primary outcome will be the change in the daily pain score from baseline to study day 105 of therapy.	—

Secondary

Measure	Time frame
Fibromyalgia Impact Questionnaire and the Patient Global Impression of Change	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026