NCT06810245

Study of PIPE-791 for Subjects With Chronic Osteoarthritis Pain or Chronic Low Back Pain

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Crossover Multicenter Study to Explore the Safety and Efficacy of Oral PIPE-791 as Treatment in Subjects With Chronic Osteoarthritis Pain (COAP) or Chronic Low Back Pain (CLBP)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Contineum Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a double-blind, randomized, placebo-controlled, 2-period crossover study designed to evaluate the safety and tolerability of PIPE-791 in approximately 20 adults with COAP and 20 adults with CLBP (with or without painful lumbosacral radiculopathy). Subjects will be randomized to receive either PIPE-791 or placebo daily for 4 weeks, followed by a crossover to the alternate treatment assignment for an additional 4 weeks. A washout period of all chronic pain medications is required prior to randomization. Rescue medications, including acetaminophen and naproxen, will be permitted during the study. Subjects will complete regular clinic visits for safety assessments, laboratory testing, and physical evaluations. Daily pain scores and dosing information will be reported by subjects using an electronic diary (e-diary). All subjects who complete dosing will have a post-treatment safety follow-up/end of study (EOS) phone visit approximately 28 days after the last dose of study drug. Subjects who prematurely discontinue dosing and all assessments from the study will have an early termination (ET) visit as soon as possible on or after their last dose of study drug. The total duration of participation, including screening, treatment, and follow-up, is approximately 16 weeks.

Conditions

• Chronic Osteoarthritis Pain
• Chronic Low Back Pain

Interventions

Type	Name	Description
DRUG	PIPE-791	PIPE-791 tablet, taken once daily for 4 weeks
DRUG	Placebo	Placebo tablet, taken once daily for 4 weeks

Timeline

• Start date: 2025-02-04
• Primary completion: 2026-01-20
• Completion: 2026-01-20
• First posted: 2025-02-05
• Last updated: 2026-03-18

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study