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Study to Evaluate the Efficacy of Milnacipran in the Treatment of Pain Due to Osteoarthritis

NCT01329406 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-08-17

No results posted yet for this study

Summary

The present study will aim to evaluate the efficacy of milnacipran in the treatment of pain due to osteoarthritis (OA), that is, to determine whether milnacipran provides superior efficacy to placebo in patients with OA. Milnacipran is a serotonin-norepinephrine reuptake inhibitor (SNRI) that is currently approved in the United States in the treatment of major depressive disorder and fibromyalgia. There is increased evidence to suggest that SNRIs may be effective in the treatment of chronic pain conditions, such as OA.

The hypothesis in this study is that the survival time (time from randomization to loss of efficacy) of milnacipran group is superior to that of placebo group.

Conditions

Interventions

DRUG

Milnacipran

1 tablet (100mg) by mouth twice daily for 28 days

DRUG

Placebo

1 tablet by mouth twice daily for 28 days

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Analgesic Solutions

    lead INDUSTRY

Principal Investigators

  • Stephen L. Wright, M.D. · Analgesic Solutions

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-02-29
Completion
2012-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01329406 on ClinicalTrials.gov