PIPE-791 for Osteoarthritis and Low Back Pain

Recruiting at 4 trial locations

Overseen By Jules Lee

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Contineum Therapeutics

Must not be taking: Capsaicin

Disqualifiers: Fibromyalgia, Rheumatoid arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

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.

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• PIPE-791

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.

How Is the Trial Designed?

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+