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

Opioid-induced Constipation research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Opioid-induced Constipation

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Subjects with opioid induced constipation

Study Status

Completed

Start Date: August 2012

Completed Date: February 2013

Phase:

Type: Observational

Design:

Primary Outcome: Semi-structured discussion guide

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Mark Sostek, MD

Lead Sponsor: AstraZeneca

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01645371

Frank L, Kleinman L, Farup C, Taylor L, Miner P Jr. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol. 1999 Sep;34(9):870-7.

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