"MILNACIPRAN" in Subjects With Chronic Shoulder Pain

NCT01289236 | Completed Phase 4

• 1 other identifier: SAV-MD-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the safety and efficacy of multiple doses of "Milnacipran" to a placebo dose in subjects with Chronic Shoulder Pain.

Conditions

Chronic Shoulder Pain

Keywords

Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint will be the reduction in the mean VAS for chronic shoulder pain

  The primary efficacy endpoint will be the reduction in the mean VAS (Visual Analog Scale) for chronic shoulder pain at Week 12

  Week 12

Secondary Outcomes (3)

• Improvement in the PGIC

  Week 12

• An improvement in the SPADI score

  Week 12

• Improvement in the SF-36 Health Questionnaire

  Week 12

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo BID (twice daily, approximately 12 hours apart)

Drug: Placebo

milnacipran 200 mg

ACTIVE COMPARATOR

200mg- 1 100mg tablet BID (twice daily, approximately 12 hours apart)

Drug: Milnacipran

milnacipran 100 mg

ACTIVE COMPARATOR

100mg- 1 50mg tablet BID (twice daily, approximately 12 hours apart)

Drug: milnacipran

Interventions

Milnacipran DRUG

1 tablet (50mg) BID (twice daily, approximately 12 hours apart) for 12 weeks after appropriate titration period

Also known as: Savella

milnacipran 100 mg

Placebo DRUG

1 tablet (placebo) BID (twice daily, approximately 12 hours apart) for 12 weeks after appropriate titration period.

Placebo

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males, postmenopausal/ sterile females or females using reliable contraceptives who are \>25 years of age.
• Chronic shoulder pain in at least one shoulder for \> 3 months (If both shoulders are painful, the investigator will choose the most painful shoulder for evaluation during the study) If both are equally painful, the investigator will choose the shoulder for evaluation.
• History of shoulder or proximal arm pain due to bursitis, osteoarthritis of the shoulder, impingement or rotator cuff tear.
• Subjects who give their written informed consent.
• Subjects who at screening are not on chronic analgesic/anti-inflammatory medication and have a VAS pain score of \> 40mm and \< 90mm or subjects who are on chronic analgesic/anti-inflammatory medication at screening and have a VAS pain score of \> 30mm and \< 90mm, indicating a lack of adequate and sustained response to current therapy.
• At baseline, after all analgesic/anti-inflammatory medication has been discontinued for 2 weeks (including withdrawal from acetaminophen rescue medication for 24 hours prior to screening) should have a VAS pain score of \> 40mm and \< 90mm.
• Subjects who are willing to discontinue all NSAIDs or other analgesic medication taken for their shoulder pain with the exception of acetaminophen 500-1000mg (1-2 tablets) q.i.d., p.r.n. (maximum 8 tablets or 4 grams per day. Subjects must be willing to use only acetaminophen as a rescue pain medication for the shoulder pain. All analgesic medications must be stopped at least 2 weeks prior to the baseline visit and all acetaminophen must be discontinued at least 24 hours prior to the baseline visit. Subjects must be willing to abstain from any peri-articular injections for the shoulder during the course of the trial.
• Subjects who have an x-ray at screening or MRI within 6 months prior to screening.

You may not qualify if:

• Women of childbearing potential may not be entered if:
• Their pregnancy tests (urine) are positive They are nursing They do not use or agree to use an effective method of contraception until all follow-up procedures are complete. (Acceptable methods of contraception are oral, injectable, implanted contraceptive agent, abstinence or an intra-uterine device with a failure rate of \< 1%
• Participation in another experimental drug/device study within the past 30 days.
• Acute infection of the study joint
• History of adverse reaction or allergy to milnacipran or acetaminophen
• Shoulder pain due to an injury for which litigation is planned or pending.
• Any cervical spine disease that in the opinion of the investigator could confound assessments during the study.
• Use of any oral corticosteroid during the past 30 days or peri-articular corticosteroid injection during the past 1 month.
• Subjects with shoulder x-ray findings of fractures or avascular necrosis.
• Subjects with any inter-current disease or condition that may interfere with the free use or evaluation of the affected shoulder for the duration of their participation in the study (severe congenital defects, weight bearing use of the shoulder due to crutches, walkers, canes etc.)
• Subjects with history of alcohol or drug abuse within the past 5 years.
• Subjects who have a compromised mental capacity or who may be unable to legally comprehend the details and nature of the study.
• In the opinion of the investigator, a clinically significant abnormal lab results or history of disease that may place the subject at a health risk or compromise the study data or affect the subject's ability to complete the study.
• Subjects who in the opinion of the investigator are unlikely to adhere to the study protocol or to complete the study as planned.
• Subject has a chronic pain condition (chronic low back pain, chronic headache, fibromyalgia, chronic osteoarthritis, chronic rheumatoid arthritis etc.) that could confound the shoulder pain response to the study medication(in the opinion of the investigator)

Sponsors & Collaborators

• Valera Bussell: lead
• Forest Laboratories: collaborator

Study Sites (1)

Delray Research Associates

Delray Beach, Florida, 33484, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Philippe A Saxe, MD,FACP

  Delray Research Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Representative

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 3, 2011
• Study Start: October 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 9, 2012

Record last verified: 2012-08

Locations

US (1)