Assessing a Stool Symptom Screener in Patients With Chronic Opioid-Induced Constipation
NCT ID: NCT01645371
Last Updated: 2014-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
79 participants
OBSERVATIONAL
2012-08-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Subjects with opioid induced constipation
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
84 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Sostek, MD
Role: STUDY_DIRECTOR
AstraZeneca
Karin S Coyne, PHD, MPH
Role: PRINCIPAL_INVESTIGATOR
United BioSource
References
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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. doi: 10.1080/003655299750025327.
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. doi: 10.1016/j.ejpain.2005.03.008.
Related Links
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D3820C00028\_statement\_of\_no\_CSR\_Synopsis.pdf
Other Identifiers
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D3820C00028
Identifier Type: -
Identifier Source: org_study_id
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