Managing Chronic Tendon Pain by Repurposing Metformin

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The purpose of the current exploratory clinical trial is to determine the effect of oral ingestion of metformin (OIM) in non-diabetic patients with chronic Achilles tendon pain. The trial has two aims; 1) to assess the effects of OIM treatment on tendon pain, and 2) to determine the effects of OIM capsules on tendon healing and repair. Twenty participants will be treated with metformin capsules for 16 weeks combined with a home exercise program. A comparison group of 20 participants will be treated with placebo tablets along with home exercise program.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• Willing and able to provide informed consent for participation

• Clinical diagnosis of Achilles tendinopathy

• Pain disability index score of between 20 - 70 points (0-100 scale VISA-A)

• Sonopalpation tenderness with tendon thickening and/or loss of fibrillary architecture.

• Ability to read, speak, and understand English

Locations
United States
Pennsylvania
University of Pittsburgh
RECRUITING
Pittsburgh
Contact Information
Primary
James H Wang, PhD
wanghc@pitt.edu
4126489102
Time Frame
Start Date: 2024-05-24
Estimated Completion Date: 2025-10
Participants
Target number of participants: 40
Treatments
Placebo_comparator: Placebo Group, Placebo Capsules
Placebo Group (n=20) Week 1: One placebo capsule (500 mg) daily Week 2: Two placebo capsules (1,000 mg) daily Week 3: Three placebo capsules (1,500 mg) daily Week 4-16: Four placebo capsules (2,000 mg) daily
Experimental: Treatment Group, Metformin Capsules
Treatment Group (n=20) Week 1: One metformin ER capsule (500 mg) daily Week 2: Two metformin (ER) capsules (1,000 mg) daily Week 3: Three metformin (ER) capsules (1,500 mg) daily Week 4-16: Four metformin (ER) capsules (2,000 mg) daily
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense
Leads: James Wang

This content was sourced from clinicaltrials.gov