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Initiation of Phase 2b Trial of Oral CR845 in Chronic Pain set for Second Half of 2016

Source Link:: http://ir.caratherapeutics.com/releasedetail.cfm?ReleaseID=960001

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Additional Information

Additional Relevant Details This will be designed as a double-blind, multiple dose Phase 2b with repeat doses of CR845 administered over an eight week treatment period in patients with moderate-to-severe pain which is greater than or equal to 5 on a 10-point scale associated with osteoarthritis. Four treatment arms oral twice a day dosage, placebo and three CR845 tablet strengths. This will be an approximately 330 patient trial run at about 15 sites in the United States.

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Additional Relevant Details Update on 9.15.16: The Phase 2b trial is a randomized, double-blind, placebo-controlled trial of three tablet strengths of CR845, 1.0 mg, 2.5 mg and 5.0 mg, dosed twice a day (BID) over an eight-week treatment period in approximately 330 osteoarthritis patients experiencing moderate-to-severe pain. The primary efficacy endpoint will be change from baseline at week eight, with respect to the weekly mean of the daily pain intensity score using a numerical rating scale (NRS). Secondary endpoints will include: change from baseline in the Western Ontario and McMaster Osteoarthritis Index (WOMAC), the Patient Global Impression of Change (PGIC) and amount of rescue medication used.

http://ir.caratherap...

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Catalyst Date

Occurred on:

Sep 15, 2016

Occurred Source:

http://ir.caratherapeutics.com/releasedetail.cfm?ReleaseID=989199

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Related Keywords Oral Cr845, Phase 2b Trial, Chronic Pain