Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

Forest Laboratories364 enrolled

Overview

To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

364

Conditions

Fibromyalgia

Interventions

No Treatment AddedDRUG

No added treatment

Milnacipran AddedDRUG

Milnacipran 100 mg/d added

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria * tolerate at least 300 mg/day of pregabalin * have an incomplete response to pregabalin treatment Exclusion Criteria: * suicidal risk * substance abuse * pulmonary dysfunction * renal impairment * active cardiac disease * liver disease * narrow angle glaucoma * autoimmune disease * cancer * inflammatory bowel disease * unstable endocrine disease * prostatic enlargement

Locations (60)

Outcomes

Primary Outcomes

Patient Global Impression of Change (PGIC) Responder Rate at End of Study

The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as "very much improved" or "much improved" (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1.

Time frame: End of Randomized treatment period (11 weeks)

Secondary Outcomes

Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study

The secondary efficacy measure was the change from Visit 2 (Week 0) in the 1-week pain recall at Visit 6 (Week 11) or End of Study, measured using a 100-mm VAS assessment of pain (0 indicating no pain and 100 indicating the worst possible pain).

Time frame: Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks)

Data from ClinicalTrials.gov

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Forest Investigative Site

Birmingham, Alabama, United States

Forest Investigative Site

Mesa, Arizona, United States

Forest Investigative Site

Peoria, Arizona, United States

Forest Investigative Site

Hot Springs, Arkansas, United States

Forest Investigative Site

Anaheim, California, United States

Forest Investigative Site

Sacramento, California, United States

Forest Investigative Site

Sacramento, California, United States

Forest Investigative Site

Torrance, California, United States

Forest Investigative Site

Walnut Creek, California, United States

Forest Investigative Site

Denver, Colorado, United States

...and 50 more locations