Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

This is a multicenter, randomized, double-blind, placebo-controlled, titration-to-effect study of orally administered CR845 in patients with osteoarthritis of the hip or knee.

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. Randomization will be stratified based on a patient's primary OA joint (knee vs. hip). 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 randomized to active study drug or placebo. Approximately 330 patients will be enrolled in this study.

During the Screening, Titration-to-Effect and Follow-up Period, pain intensity scores will be obtained at specified time points. Blood sampling and safety assessments will be conducted during this period as well.

The use of rescue medication for the treatment of any pain (including but not limited to headache, menstrual cramps, or non-target joint pain) during the study will be discussed with the patients at the Screening Visit. Acetaminophen is the only allowable rescue medication for pain beginning from Day -5 until the end of the Maintenance Treatment Period. Starting at the Screening Visit Acetaminophen will be provided as 325-mg tablets and its use (number of tablets taken in the previous 24 hours) will be reported each evening in the patient diary. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02944448
Study type Interventional
Source Cara Therapeutics, Inc.
Contact
Status Completed
Phase Phase 2
Start date September 2016
Completion date June 2017

See also
  Status Clinical Trial Phase
Recruiting NCT03660943 - A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain Phase 3
Completed NCT03643588 - The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain N/A
Not yet recruiting NCT03225911 - Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis N/A
Recruiting NCT03161093 - A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip Phase 3
Not yet recruiting NCT03457051 - Unicompartmental Knee Arthroplasty (UKA) Versus Total Knee Arthroplasty (TKA) of Medial Osteoarthritis N/A
Not yet recruiting NCT03473405 - Air Barrier System for the Reduction of Airborne Colony Forming Units During Total Knee Arthroplasty N/A
Recruiting NCT02615522 - Prospective Post Market Clinical Follow-Up of the Primary Knee Endoprosthesis BPK-S Integration N/A
Recruiting NCT02909257 - Motor-Sparing Femoral Nerve Block Dose Phase 4
Recruiting NCT02905747 - The Effect of Medical Exercise Therapy on Pain, Function and Physical Activity in Patients With Knee Osteoarthritis N/A
Not yet recruiting NCT02865174 - Topical Tranexamic Acid and Floseal® in Total Knee Arthroplasty Phase 4
Not yet recruiting NCT02854176 - Somatosensory Stimulation in Knee Osteoarthritis Phase 2
Completed NCT02881775 - Immediate Effects of rTMS on Excitability of the Quadriceps With Knee Osteoarthritis N/A
Completed NCT02901964 - Effect of Strengthening the Hip Abductor in Patients With Knee Osteoarthritis: Randomized Controlled Trial N/A
Completed NCT03037489 - A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients Phase 2
Not yet recruiting NCT02826850 - Saphenous Nerve Radiofrequency for Knee Osteoarthritis Trial Phase 3
Recruiting NCT02481427 - Finnish Unicompartmental and Total Knee Arthroplasty Investigation N/A
Recruiting NCT02680392 - Functional Outcome and Analgesia in TKA: Radiofrequency vs Continuous Adductor Canal Block N/A
Active, not recruiting NCT02229279 - Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures N/A
Active, not recruiting NCT02440672 - JOURNEY™ II CR Total Knee System N/A
Enrolling by invitation NCT02848027 - Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment Phase 3