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A Study of the Safety and Effectiveness of Orally Administered CR845 in Patients With Osteoarthritis of the Hip or Knee

NCT02524197 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2017-01-31

No results posted yet for this study

Summary

To assess the safety and tolerability of orally-administered CR845 in patients with osteoarthritis (OA) of the hip or knee. The study drug is being tested to reduce OA pain, and will be taken twice a day for two weeks, with four different doses (strengths) being tested. From screening period to follow up examination, the study is expected to last for up to 38 days per participant.

Conditions

Interventions

DRUG

CR845 0.25 mg

Subjects will dose orally twice a day with CR845 0.25 mg tablets for two weeks. A diary will be kept for recording the individual's pain scores and dosing accountability.

DRUG

CR845 0.50 mg

Subjects will dose orally twice a day with CR845 0.50 mg tablets for two weeks. A diary will be kept for recording the individual's pain scores and dosing accountability.

DRUG

CR845 1 mg

Subjects will dose orally twice a day with CR845 1 mg tablets for two weeks. A diary will be kept for recording the individual's pain scores and dosing accountability.

DRUG

CR845 5 mg

Subjects will dose orally twice a day with CR845 5 mg tablets for two weeks. A diary will be kept for recording the individual's pain scores and dosing accountability.

Sponsors & Collaborators

  • Cara Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Tiseo, PhD · Cara Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02524197 on ClinicalTrials.gov