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

NCT01329406 | Unknown Phase 4

• 1 other identifier: FRX001-2010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Osteoarthritis

Keywords

Osteoarthritis (OA); Milnacipran; Serotonin-norepinephrine reuptake inhibitor (SNRI); Knee pain

Outcome Measures

Primary Outcomes (1)

• Time to loss of efficacy in the Double-Blind Period

  The time to pain worsening by 30% compared to the value at baseline and a pain score of at least 4 on the 0-10 numerical rating scale on weekly pain assessment. Subjects who drop out due to "lack of efficacy" will be counted as efficacy failures regardless of their pain scores.

  28 days

Secondary Outcomes (7)

• Mean change in pain intensity

  28 days

• Mean change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) scores

  28 days

• The efficacy of milnacipran vs. placebo by time to dropout for all causes

  70 days

• The efficacy of milnacipran in the Open-Label Period

  28 days

• The difference between milnacipran and placebo in responder proportion in the Double-Blind Period

  28 days

Study Arms (2)

Milnacipran

EXPERIMENTAL

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).

Drug: Milnacipran

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Milnacipran DRUG

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

Milnacipran

Placebo DRUG

1 tablet by mouth twice daily for 28 days

Placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 21-75 years of age and in good general medical and psychological health
• Be able to speak, read, write, and understand English, understand the consent form, complete study related procedures, and communicate with the study staff
• Have a negative urine pregnancy test at screening, and use appropriate birth control
• Have documented painful Osteoarthritis (OA) of at least one knee for at least 6 months; OA should be of Class I-III and meet the American College of Rheumatology (ACR) clinical classification criteria, defined as:
• Knee pain and at least 3 of the following 6:
• Age \> 50
• Morning stiffness \< 30 minutes
• Crepitus on active motion
• Bony tenderness
• Bony enlargement
• No palpable warmth of synovium
• The target joint must not contain any type of orthopedic and/or prosthetic device
• Have a target joint pain average of 5 days per week and have an average pain intensity of at least 4/10 on the 0-10 NRS over the last 24 hours prior to screening
• Have stable treatment modalities, e.g. acupuncture, physical therapy
• Be willing to stop taking Non-steroidal Anti-inflammatory drugs (NSAIDs) and opioids for the duration of the study

You may not qualify if:

• Are allergic or intolerant to SNRI; have a previous poor response to a SNRI for OA pain; are currently taking an SNRI or tricyclic antidepressant
• Have a body mass index (BMI) \>40 kg/m2
• Have an Hospital Anxiety and Depression Scale (HADS) score \>12 on either subscale or has an established history of major depressive disorder not controlled with medication
• Have significant pain outside the target knee, including significant hip or back pain. (Bilateral knee OA allowed.)
• Have pain affecting the target knee that is due to any other etiology than OA
• Have documented history of inflammatory arthritis including rheumatoid arthritis
• Have had local injections in target joint within the past 3 months prior to screening
• Have had oral or intramuscular corticosteroids within the past 30 days
• Have had worker's compensation claim, disability, or litigation
• Have a known history of uncontrolled narrow-angle glaucoma
• Have a known history of suicidal ideation
• Use monoamine oxidase inhibitors (MAOI) concomitantly
• Are allergic or intolerant to acetaminophen
• Using opioids 4 or more days per week during the month preceding the screening visit
• Have significant history or renal impairment/failure.

Sponsors & Collaborators

• Analgesic Solutions: lead
• Forest Laboratories: collaborator

Study Sites (1)

Analgesic Solutions

Natick, Massachusetts, 01760, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Stephen L. Wright, M.D.

  Analgesic Solutions

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 5, 2011
• Study Start: July 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: September 1, 2012
• Last Updated: August 17, 2011

Record last verified: 2011-08

Locations

US (1)