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NCT Number: NCT01645371

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

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.

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Key information

Conditions

Opioid-induced Constipation Chemically-Induced Disorders Constipation Mental Disorders Narcotic-Related Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Semi-structured discussion guide

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 20, 2012
Registry last updated
Oct 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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