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

Opioid-induced Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01645371
• Other study ID #: D3820C00028
• Status: Completed
• Phase: N/A
• First received: July 12, 2012
• Last updated: October 17, 2014
• Start date: August 2012
• Est. completion date: February 2013

Study information

• Verified date: October 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 84 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Constipation
• Opioid-induced Constipation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

References & Publications (2)

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. — View Citation

Slappendel R, Simpson K, Dubois D, Keininger DL. Validation of the PAC-SYM questionnaire for opioid-induced constipation in patients with chronic low back pain. Eur J Pain. 2006 Apr;10(3):209-17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Semi-structured discussion guide	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.	Data will be collected at ONE time point from each patient using a semi-structured interview guide (up to 5 months)	No

External Links

•   D3820C00028_statement_of_no_CSR_Synopsis.pdf