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| Sponsor: | Bnai Zion Medical Center |
|---|---|
| Information provided by: | Bnai Zion Medical Center |
| ClinicalTrials.gov Identifier: | NCT00983177 |
Purpose
Chronic pain due to calcific tendonitis of shoulder is a prevalent condition usually treated with recurrent courses of NSAIDs, physical therapy or surgical interventions. Colchicine has been reported to be effective in the acute attack of shoulder tendonitis, however, has never been examined in controlled study in patients with chronic shoulder pain secondary to calcific tendonitis. Eighty patients with chronic shoulder pain (at least 3 months duration) due to calcific tendonitis will be randomized to receive colchicine 0.5 mg twice daily or placebo (lactose capsules) for 4 months. At the end of this blinded part of the study, patients who received placebo and did not improve, will be eligible to continue study in the open mode for additional 4 months with study drug. Efficacy (VAS for shoulder pain, shoulder range of motion and shoulder pain and disability index) and safety (blood tests) follow-ups will be scheduled bi-monthly for all patients.
| Condition | Intervention |
|---|---|
|
Calcific Tendonitis |
Drug: Colchicine Drug: lactose |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis: Double Blind Placebo-controlled Study |
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: colchicine |
Drug: Colchicine
0.5 mg twice daily for 4 months
|
| Placebo Comparator: Lactose capsule |
Drug: lactose
lactose capsules twice daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Gleb Slobodin, MD | 972-506267284 | gleb.slobodin@b-zion.org.il |
| Israel | |
| Bnai Zion Medical Center | Recruiting |
| Haifa, Israel | |
| Contact: Gleb Slobodin, MD gleb.slobodin@b-zion.org.il | |
| Principal Investigator: Gleb Slobodin, MD | |
| Study Director: | Itzhak Rosner, MD | Bnai Zion Medical Center |
More Information
| Responsible Party: | Gleb Slobodin, Bnai Zion Medical Center |
| ClinicalTrials.gov Identifier: | NCT00983177 History of Changes |
| Other Study ID Numbers: | colchicine1 |
| Study First Received: | September 22, 2009 |
| Last Updated: | July 18, 2010 |
| Health Authority: | Israel: Ministry of Health |
|
Shoulder Pain Tendinopathy Calcinosis Arthralgia Joint Diseases Musculoskeletal Diseases Pain Signs and Symptoms Muscular Diseases Tendon Injuries Wounds and Injuries Calcium Metabolism Disorders |
Metabolic Diseases Colchicine Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Gout Suppressants Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |