CompletedPhase 1

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

United States43 participantsStarted 2025-02-04

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Investigat…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since PIPE-791 is a Phase 1 trial focused mainly on tracking side effects rather than proving it works, what do the early safety results actually show, and does that change whether it might be worth pursuing?
2This trial is already completed — does that mean the safety data is available yet, and if so, can you help me understand what kinds of adverse events were reported in people with conditions like mine?
3Given that this was an early-phase study, are there any follow-on trials for PIPE-791 that I might be eligible for, or is it too soon to know if this drug will move forward?
4For my specific situation — whether it's osteoarthritis pain or low back pain — is there a standard treatment I should try first before considering experimental options like this one?
5Since Phase 1 trials are primarily about safety and not yet about effectiveness, what would need to happen in later phases before a drug like PIPE-791 could realistically become part of my treatment plan?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of subjects with Treatment-emergent adverse events (TEAEs)

Timeframe: For Treatment Period 1, from Baseline (Day 1) to End of Treatment Period 1 (TP1; Day 29), for Treatment Period 2, from Baseline of Treatment Period 2 (TP2; Day 29) to End of TP2 (Day 57).

Trial details

NCT IDNCT06810245

SponsorContineum Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-20

View on ClinicalTrials.gov More Chronic Osteoarthritis Pain trials