Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-03-03 @ 10:05 AM
Study NCT ID:
NCT02660606
Status:
COMPLETED
Last Update Posted:
2020-04-15
First Post:
2016-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Qualitative Study to Assess the Content Validity of the Prescription Opioid Misuse and Abuse Questionnaire
Sponsor:
Member Companies of the Opioid PMR Consortium
Organization:
Study Overview
Official Title:
A Qualitative Study to Assess the Content Validity of the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POMAQ
Brief Summary:
The purpose of this study is to evaluate the patient usability and reliability of the POMAQ survey to evaluate opioid misuse and abuse among adults with chronic moderate to severe pain, including patients who are opioid abusers, non-abusers, as well as non-opioid users
Detailed Description:
The Food and Drug Administration (FDA) has requested, as part of a post-marketing requirement (PMR) for new drug application (NDA) holders of extended release/long-acting (ER/LA) opioids, to conduct a study to develop and validate a measure of the opioid-related adverse events misuse and abuse among patients with chronic pain prescribed long-term opioid therapy. This measure will be used to assess misuse and abuse in PMR Study 2065-1A and PMR Study 2065-4B.
Currently, no tool exists to meet this need except for the Self-report Misuse, Abuse and Diversion of Prescription (Rx) Opioids questionnaire (SR-MAD) which has undergone several rounds of prior content validation. The SR-MAD has been modified to meet the needs of PMR Studies 2065-1A and 2065-4B, and has been renamed the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ).
This study will seek to further develop and validate the POMAQ using the the Food and Drug Administration (FDA) Guidance for Industry, Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (FDA 2009) as a reference for conducting qualitative research throughout the process of instrument development to ensure the content validity of a measure and to evaluate the comprehensibility of included questions. This qualitative study to evaluate content validity will be conducted prior to the quantitative study to evaluate construct validity
Currently, no tool exists to meet this need except for the Self-report Misuse, Abuse and Diversion of Prescription (Rx) Opioids questionnaire (SR-MAD) which has undergone several rounds of prior content validation. The SR-MAD has been modified to meet the needs of PMR Studies 2065-1A and 2065-4B, and has been renamed the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ).
This study will seek to further develop and validate the POMAQ using the the Food and Drug Administration (FDA) Guidance for Industry, Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (FDA 2009) as a reference for conducting qualitative research throughout the process of instrument development to ensure the content validity of a measure and to evaluate the comprehensibility of included questions. This qualitative study to evaluate content validity will be conducted prior to the quantitative study to evaluate construct validity
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 3033-3 | OTHER | Member Companies of the Opioid PMR Consortium | View |