Assessing a Stool Symptom Screener in Patients With Chronic Opioid-Induced Constipation

Completed

• Conditions: Opioid-induced Constipation

• Registration Number: NCT01645371
• Lead Sponsor: AstraZeneca

Brief Summary

This qualitative research is to assess the validity of the stool symptom screener that will be used in patients with chronic opioid-induced constipation to determine the adequacy of their response to laxatives.

Detailed Description

Assessing the Content Validity of a Stool Symptom Screener in Patients with Chronic Opioid-Induced Constipation

Study Timeline

• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-07-18
• Study First Posted: 2012-07-20
• Study Start: 2012-08
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-17
• Last Update Posted: 2014-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• Receiving a stable maintenance opioid regimen (total daily dose of 30-1000mg of oral morphine, or equianalgesic amounts of 1 or more other opioid therapies) for a minimum of 4 weeks for non-cancer related pain.
• Development of constipation symptoms since starting opioids.
• Taken laxatives to help with bowel movements for at least four days over the past 2 weeks.

Exclusion Criteria

• Receiving opioid regimen for treatment of pain related to cancer.
• Participated in any clinical trial or research study relating to opioid use and/or constipation within the past year.
• History of cancer within 5 years from the time of screening.
• Has medical condition(s) and/or treatment(s) associated with diarrhea, intermittent loose stools, or constipation (e.g., fecal incontinence or chronic idiopathic constipation).
• Has irritable bowel syndrome (IBS) or chronic functional constipation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Semi-structured discussion guide	Data will be collected at ONE time point from each patient using a semi-structured interview guide (up to 5 months)	Using a semi-structured discussion guide during a single one-on-one interview, qualitative information will be collected from subjects that relates to their experience with Opioid Induced Constipation symptoms and to their understanding and perception of a verbally-administered stool symptom screener.