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

AstraZeneca

Status: Completed

Conditions: Opioid-induced Constipation

Study type: Observational

Funder types: Industry

Identifiers

NCT01645371

D3820C00028

Details and patient eligibility

About

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.

Full description

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

Enrollment: 79 patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No 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.

Trial design

79 participants in 1 patient group

Subjects with opioid induced constipation