A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee

Completed · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis, Hip, Osteoarthritis, Knee, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases

In brief

The study schedule consists of a Screening Period (up to 14 days), a blinded 4- week Titration-to-Effect Period with weekly visits, a blinded 4-week Maintenance Treatment Period at the optimal dose level determined for each patient, and a 1-week Follow-up Period. Eligible patients will be randomized to receive either CR845 or placebo in a 2:1 ratio. Every patient will be started on a 1-mg dose of CR845 or matching placebo. During the post-randomization Titration-to-Effect period, the dose of study drug may be increased to 2.5 mg or 5 mg in a double-blind fashion. Patients may know their dose is being changed but will not know whether they were randomization to active study drug or placebo. Approximately 330 patients will be enrolled in this study.

Key facts

Study ID

NCT02944448

Run by

Cara Therapeutics, Inc.

People needed

761

Starts

2016-09-01

Expected to finish

2017-06-01

Last updated by the study team

2020-10-20

Who can join

Age: 25 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntarily provides written informed consent to participate in the study prior to any study procedures.
• Is able to speak, read, and communicate clearly in English or Spanish; is able to understand the study procedures.
• Male or female ≥ 25 years of age.
• Body mass index (BMI) ≤ 40 kg/m2.
• Has OA of the hip or knee according to American College of Rheumatology (ACR) criteria.
• Reports an average pain intensity level ≥ 5 in the index joint at Screening on a 0-10 NRS scale.
• Is either opioid-naïve (defined as taking < 10 mg a day of morphine equivalent 14 days prior to screening) or opioid-experienced. If receiving opioid analgesic medication for OA, patients must be on a stable dose ≤ 40 mg of morphine equivalents for 14 days prior to screening.
• Willing to discontinue currently used pain medications beginning 5 days prior to the Baseline Visit and throughout the study. Acetaminophen use is allowed. (Section 8.8)
• If female:
• Of childbearing potential - the patient must be willing to practice an acceptable form of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence from sexual intercourse) for the duration of treatment and for at least 3 days following the last dose of study drug.
• Of non-childbearing potential - the patient must be surgically or biologically sterile (hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or postmenopausal for at least 1 year).
• If male, the patient must be surgically or biologically sterile. If not sterile, the patient must agree to use an acceptable form of birth control with a heterosexual partner (as described in inclusion criterion #9) or abstain from sexual relations during the treatment period and for 3 days following the last dose of study drug.
• Is free of other physical, mental, or medical conditions that, in the opinion of the Investigator, would make study participation inadvisable.
• Reports a daily pain intensity score in the index joint ≥ 5 (on a 0-10 NRS scale) during 4 or more of the last 7 days prior to randomization, with 2 consecutive days ≥ 5 occurring just prior to randomization

You may not qualify if…

• Inclusion Criteria:
• A patient will be eligible for enrollment if the following criteria are met:
• Voluntarily provides written informed consent to participate in the study prior to any study procedures.
• Is able to speak, read, and communicate clearly in English or Spanish; is able to understand the study procedures.
• Male or female ≥ 25 years of age.
• Body mass index (BMI) ≤ 40 kg/m2.
• Has OA of the hip or knee according to American College of Rheumatology (ACR) criteria.
• Reports an average pain intensity level ≥ 5 in the index joint at Screening on a 0-10 NRS scale.
• Is either opioid-naïve (defined as taking < 10 mg a day of morphine equivalent 14 days prior to screening) or opioid-experienced. If receiving opioid analgesic medication for OA, patients must be on a stable dose ≤ 40 mg of morphine equivalents for 14 days prior to screening.
• Willing to discontinue currently used pain medications beginning 5 days prior to the Baseline Visit and throughout the study. Acetaminophen use is allowed. (Section 8.8)
• If female:
• Of childbearing potential - the patient must be willing to practice an acceptable form of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence from sexual intercourse) for the duration of treatment and for at least 3 days following the last dose of study drug.
• Of non-childbearing potential - the patient must be surgically or biologically sterile (hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or postmenopausal for at least 1 year).
• If male, the patient must be surgically or biologically sterile. If not sterile, the patient must agree to use an acceptable form of birth control with a heterosexual partner (as described in inclusion criterion #9) or abstain from sexual relations during the treatment period and for 3 days following the last dose of study drug.
• Is free of other physical, mental, or medical conditions that, in the opinion of the Investigator, would make study participation inadvisable.
• Reports a daily pain intensity score in the index joint ≥ 5 (on a 0-10 NRS scale) during 4 or more of the last 7 days prior to randomization, with 2 consecutive days ≥ 5 occurring just prior to randomization
• Exclusion Criteria:
• Has had a joint replacement in the index joint.
• Has received an intra-articular injection of corticosteroids or hyaluronic acid in the index joint within 3 months prior to the Screening Visit.
• Has started a new medication for chronic illness within 30 days prior to the Screening Visit.
• Is receiving opioid analgesic treatment for OA of the hip or knee at a dose > 40 mg of morphine equivalent.
• Uses antipsychotics, antiepileptics, sedatives, hypnotics, or antianxiety agents, selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants with a dose change <30 days prior to day 1 of the study.
• Has a history or current diagnosis of substance dependence (except caffeine or nicotine) or alcohol abuse, according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
• Has a positive urine drug screen for drugs of abuse at Screening.
• Has been diagnosed with a condition of hyperhidrosis (excessive sweating) or primary hypodipsia (a reduced sense of thirst).

Where it is running

• Cara Therapeutics Study Site — Birmingham, Alabama, United States
• Cara Therapeutics Study Site — Peoria, Arizona, United States
• Cara Therapeutics Study Site — Phoenix, Arizona, United States
• Cara Therapeutics Study Site — Carmichael, California, United States
• Cara Therapeutics Study Site — San Diego, California, United States
• Cara Therapeutics Study Site — Tustin, California, United States
• Cara Therapeutics Study Site — Homestead, Florida, United States
• Cara Therapeutics Study Site — Jupiter, Florida, United States
• Cara Therapeutics Study Site — Lake Worth, Florida, United States
• Cara Therapeutics Study Site — Miami, Florida, United States
• Cara Therapeutics Study Site — Oldsmar, Florida, United States
• Cara Therapeutics Study Site — Orlando, Florida, United States
• Cara Therapeutics Study Site — Plantation, Florida, United States
• Cara Therapeutics Study Site — South Miami, Florida, United States
• Cara Therapeutics Study Site — Tampa, Florida, United States
• Cara Therapeutics Study Site — Savannah, Georgia, United States
• Cara Therapeutics Study Site — Hazelwood, Missouri, United States
• Cara Therapeutics Study Site — Omaha, Nebraska, United States
• Cara Therapeutics Study Site — Las Vegas, Nevada, United States
• Cara Therapeutics Study Site — Berlin, New Jersey, United States
• Cara Therapeutics Study Site — Binghamton, New York, United States
• Cara Therapeutics Study Site — Rochester, New York, United States
• Cara Therapeutics Study Site — Cincinnati, Ohio, United States
• Cara Therapeutics Study Site — Cincinnati, Ohio, United States
• Cara Therapeutics Study Site — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.