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

CompletedPhase 1NCT06810245
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
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)
Conditions
Interventions
Sponsor
Contineum Therapeutics
Start date
2025-02-04
Primary completion
2026-01-20
Sex
All
Age range
from 18 Years to 70 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
5

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Key Inclusion Criteria * Male or female 18 to 70 years of age, inclusive, at the first Screening visit. * Only one of the following chronic pain diagnoses at least 6 months prior to Screening: * Osteoarthritis of the knee OR low back pain (with or without painful lumbosacral radiculopathy) * Plain radiographs of the knee or lumbar spine consistent with diagnosis within 9 months prior to or during Screening. * History of related daily pain for at least 6 months prior to Screening. * Have a body mass index \<40 (inclusive) at Screening. * Willing to maintain a consistent regimen of any ongoing (stable format and frequency for the duration of study participation) non-pharmacologic pain-relieving therapies. * Willing to discontinue medications taken for chronic pain conditions and usage of transcutaneous electrical nerve stimulation for the duration of the study. * Male or female subjects with reproductive potential agree to comply with a highly effective contraceptive method as per protocol through 90 days after last study drug administration. * Subjects taking systemic hormone-replacement therapy must be on a stable dose and regimen for at least 1 month prior to Screening. * General good medical health with no clinically significant or relevant abnormalities except those attributed to the underlying chronic pain condition, including medical history, physical exam, vital signs, ECG, and laboratory evaluations (hematology, chemistry, and urinalysis) as assessed by the Investigator. * Ability to use an eDiary to record daily pain scores. Key Exclusion Criteria * History of refractory chronic pain after multiple failed treatments as determined by the Investigator (e.g., no response to all of the following: surgery and/or nerve blocks, a regimen of at least two non-opioid pharmacotherapies, and physical rehabilitation, and weak opioids). * Concurrent diagnosis of fibromyalgia or evidence of chronic widespread pain, or other pain that may interfere with the assessment of CLBP or COAP. * Demonstrated noncompliance recording daily Numerical Rating Scale (NRS) scores during Screening. * Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest, e.g., an ablation procedure. * Received capsaicin treatment (e.g., Qutenza) within the past 3 months prior to screening. * Have surgery planned during the study for any reason, related or not, to the disease state under evaluation. * Are non-ambulatory (use of assis…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06810245