ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2025-02-04
Study Completion:2026-02-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06810245

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

Arizona Research Center
Phoenix, Arizona, 85053
United States
Drug Studies America
Marietta, Georgia, 30060
United States
Drug Trials America
Hartsdale, New York, 10530
United States
Altoona Center of Clinical Research
Duncansville, Pennsylvania, 16635
United States
JBR Clinical Research
Salt Lake City, Utah, 84107
United States

Collaborators and Investigators

Sponsor: Contineum Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-04
Study Completion Date2026-02-15

Study Record Updates

Study Start Date2025-02-04
Study Completion Date2026-02-15

Terms related to this study

Keywords Provided by Researchers

  • chronic pain
  • pain
  • low back pain
  • osteoarthritis pain
  • osteoarthritis
  • pain management
  • neuropathic pain
  • CLBP
  • COAP
  • OA

Additional Relevant MeSH Terms

  • Chronic Osteoarthritis Pain
  • Chronic Low Back Pain