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New pill aims to ease chronic pain without opioids

NCT ID NCT06810245

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested whether an experimental pill called PIPE-791 is safe and can lower pain in adults with long-term osteoarthritis knee pain or chronic low back pain. 43 participants stopped their usual pain meds, then took either the study drug or a placebo daily for 4 weeks, then switched for another 4 weeks. The main goal was to check for side effects and see if pain levels improved.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

43 people

The number who actually took part.

Started

Feb 2025

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 assistive devices is allowed). * History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, or amyloidosis. * Diagnosed with OA during childhood or adolescence, including post-traumatic OA or OA due to genetic (e.g., hip dysplasia) or congenital (e.g., metabolic disorders) conditions. * History of or clinical signs or symptoms of active joint infection, crystal disease of the knee, or a history of arthritis due to crystals (e.g., gout, pseudo gout). * History of prior lumbar or thoracic spine surgery (e.g., discectomies, laminectomies, foraminotomies, or fusion).

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Conditions

The condition(s) this trial relates to.

agnosia Chronic Pain Low Back Pain neuralgia osteoarthritis Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Altoona Center of Clinical Research

    Duncansville, Pennsylvania, 16635, United States

  • 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

  • JBR Clinical Research

    Salt Lake City, Utah, 84107, United States

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