Recruiting
Phase 4

Milnacipran

Sponsor:

Analgesic Solutions

Code:

NCT01329406

Conditions

Osteoarthritis

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Milnacipran

Placebo

Study Details

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

Study ID

NCT01329406

Start date

Jul, 2011

Status verified date

Aug, 2011

Completion date

Sep, 2012

Anticipated

Primary completion date

Feb, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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:

1. 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
2. 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Milnacipran

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).

placebo comparator: Placebo

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.

Interventions

Milnacipran

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

Placebo

1 tablet by mouth twice daily for 28 days

Primary outcome measure

  • Time to loss of efficacy in the Double-Blind Period [ Time Frame: 28 days ]

Central Contacts and Locations

Locations

Analgesic Solutions

Recruiting

Natick, Massachusetts, United States, 01760

Contacts

Karen Cowles, RN, MPH

781-444-9605kcowles@analgesicsolutions.com

Courtney Lincoln

781-444-9605clincoln@analgesicsolutions.com

Principal Investigator:

Stephen L. Wright, M.D.

More Information

Sponsor

Analgesic Solutions

Last update posted

Aug 17, 2011

Last verified

Aug, 2011

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Analgesic Solutions on 2011-08-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.