U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. DDT COA #000102: Physical Activity Accelerometry Assessment for Analgesic Clinical Trials (PAACT)
  1. Drugs

DDT COA #000102: Physical Activity Accelerometry Assessment for Analgesic Clinical Trials (PAACT)

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Drug Evaluation (ODE) II
Division of Anesthesia, Analgesia, and Addiction Products (DAAAP)

DDT COA Number
DDT COA #000102

Instrument Name
Physical Activity Accelerometry Assessment for Analgesic Clinical Trials (PAACT)

Disease/Condition
Musculoskeletal pain

Concept of Interest
Physical activity

Context of Use
Non-cognitively impaired adults with a diagnosis of osteoarthritis of the knee

COA Type
Digital Monitoring COA

Qualification Stage
Letter of Intent - Accepted

Requestor(s)
Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION)
Contact(s)
Kushang Patel

Date Accepted into CDER’s COA Qualification Program
May 31, 2018

Submission and Regulatory Correspondence History

Qualification Submission Date FDA Submission Decision & Recommendations Date
Letter of Intent 12/14/17 FDA Response (Accepted) 5/10/18

Back to Clinical Outcome Assessments (COA) Qualification Submission