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Serotonin-norepinephrine reuptake inhibitor

Milnacipran for Osteoarthritis

Phase 4
Waitlist Available
Led By Stephen L. Wright, M.D.
Research Sponsored by Analgesic Solutions
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 70 days
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~70 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 70 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to loss of efficacy in the Double-Blind Period
Secondary outcome measures
Mean change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) scores
Mean change in pain intensity
Safety and tolerability by monitoring adverse events
+4 more

Side effects data

From undefined Phase 4 trial • 340 Patients • NCT01014585
4%
Sinusitis
4%
Headache
4%
Nausea
4%
Upper respiratory tract infection
3%
Fibromyalgia
2%
Oedema peripheral
2%
Bronchitis
2%
Constipation
1%
Non-cardiac chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Responders: Milnacipran (Milnacipran Continued)
Non-Responders: Placebo (Milnacipran Withdrawn)
Responders: Placebo (Milnacipran Withdrawn)
Non-Responders: Milnacipran (Milnacipran Continued)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MilnacipranExperimental Treatment1 Intervention
If subjects meet the criteria to enter the Double-Blind Period, they will be randomized at a 1:1 ratio to take either milnacipran or placebo for 4 weeks. The milnacipran arm will take milnacipran at 200mg/day (100mg twice daily).
Group II: PlaceboPlacebo Group1 Intervention
If subjects meet the criteria to enter the Double-Blind Period, they will be randomized at a 1:1 ratio to take either milnacipran or placebo for 4 weeks. The placebo group will take 1 tablet twice daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Milnacipran
FDA approved

Find a Location

Who is running the clinical trial?

Analgesic SolutionsLead Sponsor
8 Previous Clinical Trials
453 Total Patients Enrolled
2 Trials studying Osteoarthritis
95 Patients Enrolled for Osteoarthritis
Forest LaboratoriesIndustry Sponsor
337 Previous Clinical Trials
89,129 Total Patients Enrolled
3 Trials studying Osteoarthritis
872 Patients Enrolled for Osteoarthritis
Stephen L. Wright, M.D.Principal InvestigatorAnalgesic Solutions

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Efficacy of Milnacipran in the Treatment of Pain Due to Osteoarthritis
2011. "Study to Evaluate the Efficacy of Milnacipran in the Treatment of Pain Due to Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01329406.
All > Arthritis > Oa
~4 spots leftby Apr 2025
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