PIPE-791 for Osteoarthritis and Low Back Pain

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Contineum Therapeutics

Must not be taking: Capsaicin

Disqualifiers: Fibromyalgia, Rheumatoid arthritis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The primary goal of this clinical trial is to learn if PIPE-791 is safe and well-tolerated in adults with chronic osteoarthritis pain (COAP) or chronic low back pain (CLBP). The study will also explore whether PIPE-791 lowers pain in people with COAP or CLBP. Subjects will: * Complete a washout period to stop their current pain medications. * Take a daily dose of PIPE-791 or placebo for 4 weeks, then reverse treatment assignment for another 4 weeks. * Record pain levels and track dosing in a daily e-diary. * Visit the clinic for checkups and lab tests throughout the study. * Complete phone assessments during the treatment periods.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current pain medications before starting the trial. There is a washout period (time without taking certain medications) to ensure this.

Research Team

Eligibility Criteria

This trial is for adults aged 18-70 with chronic osteoarthritis knee pain or low back pain, who've had daily pain for at least 6 months. Participants must stop current pain meds and maintain any non-drug therapies they're using. They need recent x-rays showing their condition and a BMI under 40. Those who can have children must use effective birth control during the study.

Inclusion Criteria

I have had knee osteoarthritis or low back pain for at least 6 months.

Body mass index <40 at Screening

Ability to use an eDiary to record daily pain scores

Exclusion Criteria

Demonstrated noncompliance recording daily Numerical Rating Scale (NRS) scores during Screening

I am scheduled for surgery during the study, related or not to my current condition.

I was diagnosed with osteoarthritis as a child or teen.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Washout

Participants undergo a washout period to stop their current pain medications

2 weeks

Treatment Period 1

Participants receive either PIPE-791 or placebo daily for 4 weeks

4 weeks

Regular clinic visits and phone assessments

Treatment Period 2

Participants crossover to the alternate treatment assignment for an additional 4 weeks

4 weeks

Regular clinic visits and phone assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Post-treatment safety follow-up/end of study phone visit

Treatment Details

Interventions

• PIPE-791 (Other)

Trial Overview The trial tests PIPE-791's safety and effectiveness in reducing chronic osteoarthritis or low back pain compared to a placebo. Participants will take PIPE-791 or placebo for four weeks, switch treatments for another four weeks, keep an e-diary of their pain levels, attend clinic visits, and do phone assessments.

Participant Groups

Group I: Placebo followed by Active Experimental Treatment 2 Interventions

Group II: Active followed by Placebo Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Contineum Therapeutics

Lead Sponsor

Trials

7

Recruited

400+