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Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia

Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fibromyalgia

Intervention: Placebo (Drug); Milnacipran (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Allan Spera, Study Director, Affiliation: Forest Research Institute Inc., A Subsidiary of Forest Laboratories

Summary

The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia.

Clinical Details

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Switch Study to Evaluate the Safety, Tolerability and Efficacy of Milnacipran in Patients With an Inadequate Response to Duloxetine for the Treatment of Fibromyalgia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)

Secondary outcome: Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score

Detailed description:

- Two weeks Duloxetine 60 mg Open-Label Period

- Randomization to Double-Blind Treatment Period: 10 weeks Milnacipran (direct switch) or

10 weeks placebo (one week blinded 30 mg duloxetine)

- One week Double-Blind Down-Taper Period

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of fibromyalgia

- Have been treated with a stable dosage of duloxetine (60 mg/day) for ≥ 4 weeks

immediately before Screening (Visit 1)

- Duloxetine must have been prescribed for the treatment of Fibromyalgia

- Have a VAS 1-week pain recall score ≥ 40 mm and ≤ 90 mm

- At Visit 2, to be eligible to enter the randomized treatment period, must continue to

have a VAS 1-week pain recall score ≥ 40 mm and be dissatisfied with current Duloxetine treatment. Exclusion Criteria:

- Suicidal risk

- History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current

episode of major depressive disorder

- Myocardial infarction and/or stroke within the prior 6 months

- Systolic blood pressure > 160 mm Hg or mean diastolic blood pressure > 100 mm Hg at

Screening (Visit 1)

- Substance abuse

- Pulmonary dysfunction

- Severe renal impairment

- Active cardiac disease

- Liver disease

- Uncontrolled narrow-angle glaucoma

- Autoimmune disease

- Cancer

- Inflammatory bowel disease

- Unstable endocrine disease

- Prostatic enlargement

- Female patients who are pregnant or breastfeeding

Locations and Contacts

Forest Investigative Site 013, Sacramento, California 95825, United States

Forest Investigative Site 022, Cromwell, Connecticut 06416, United States

Forest Investigative Site 021, Danbury, Connecticut 06810, United States

Forest Investigative Site 007, Delray Beach, Florida 33484, United States

Forest Investigative Site 008, Ocala, Florida 34471, United States

Forest Investigative Site 009, Orlando, Florida 32806, United States

Forest Investigative Site 016, Orlando, Florida 32806, United States

Forest Investigative Site 012, St. Petersburg, Florida 33709, United States

Forest Investigative Site 019, Tampa, Florida 33614, United States

Forest Investigative Site 006, Atlanta, Georgia 30328, United States

Forest Investigative Site 024, Atlanta, Georgia 30328, United States

Forest Investigative Site 015, Evansville, Indiana 47713, United States

Forest Investigative Site 005, Worchester, Massachusetts 01610, United States

Forest Investigative Site 010, Jackson, Mississippi 39202, United States

Forest Investigative Site 025, St. Louis, Missouri 63141, United States

Forest Investigative Site 018, Willingboro, New Jersey 08046, United States

Forest Investigative Site 014, Syracuse, New York 13210, United States

Forest Investigative Site 023, Charlotte, North Carolina 28209, United States

Forest Investigative Site 002, Cincinnati, Ohio 45219, United States

Forest Investigative Site 003, Cleveland, Ohio 44122, United States

Forest Investigative Site 001, Medford, Oregon 97504, United States

Forest Investigative Site 020, Mechanicsburg, Pennsylvania 17055, United States

Forest Investigative Site 011, Greer, South Carolina 29651, United States

Forest Investigative Site 004, Salt Lake City, Utah 84102, United States

Forest Investigative Site 017, Bellevue, Washington 98007, United States

Forest Investigative Site 026, Racine, Wisconsin 53406, United States

Additional Information

Starting date: February 2010
Last updated: December 21, 2011

Page last updated: August 23, 2015

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