Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT02462850
Brief Summary:
The purpose of CLCT-006, a multi-center open-label study, is to evaluate the safety of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) for the treatment of moderate to severe acute pain ("flare") associated with osteoarthritis of the knee or hip under actual conditions of use.
Detailed Description:
The purpose of CLCT-006, a multi-center open-label study, is to evaluate the safety of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) for the treatment of moderate to severe acute pain ("flare") associated with osteoarthritis of the knee or hip under actual conditions of use.
The study will also endeavor to determine
* the physicians' global evaluation of CL-108 as a treatment for moderate to severe acute pain associated with osteoarthritis of the knee or hip
* the patients' global impression of change in pain after treatment of moderate to severe acute pain associated with osteoarthritis of the knee or hip
* any change in the patient's quality of life after treatment of moderate to severe acute pain associated with osteoarthritis of the knee or hip
* the percentage change in pain intensity after treatment of moderate to severe acute pain associated with osteoarthritis of the knee or hip
Study:
NCT02462850
Study Brief:
Protocol Section:
NCT02462850