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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01645371

Enrollment

Registered

2012-07-20

Start date

2012-08-31

Completion date

2013-02-28

Last updated

2014-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid-induced Constipation

Keywords

opioid-induced constipation

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 84 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results