"MILNACIPRAN" in Subjects With Chronic Shoulder Pain
CompletedPhase 4NCT01289236
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- An Exploratory, Randomized, Single Blinded, Placebo-Controlled, Dose-Ranging Study of the Safety and Efficacy of "MILNACIPRAN" in Subjects With Chronic Shoulder Pain
- Conditions
- Interventions
- Sponsor
- Valera Bussell
- Collaborators
- Forest Laboratories
- Organization
- Delray Research Associates
- Start date
- 2009-10
- Primary completion
- 2011-06
- Sex
- All
- Age range
- from 25 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Males, postmenopausal/ sterile females or females using reliable contraceptives who are \>25 years of age. 2. 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. 3. History of shoulder or proximal arm pain due to bursitis, osteoarthritis of the shoulder, impingement or rotator cuff tear. 4. Subjects who give their written informed consent. 5. 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. 6. 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. 7. 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. 8. Subjects who have an x-ray at screening or MRI within 6 months prior to screening. Exclusion Criteria: 1. 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% 2. Participation in another experimental drug/device study within the past 30 days. 3. Acute infection of the study joint 4. History of adverse reaction or allergy to milnacipran or acetaminophen 5. Shoulder …
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01289236