NCT01645371|Completed
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
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Assessing the Content Validity of a Stool Symptom Screener in Patients With Chronic Opioid-Induced Constipation
Sponsor study identifier
observational
79
0 countries
N/A
Study Start
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2013
Actual (reported)Study Completion
February 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 12, 2012
Actual (reported)July 20, 2012
Actual (reported)August 2012
Date type not reportedThis date has not been verified as actual or estimated.
February 2013
Actual (reported)February 2013
Actual (reported)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)
multi-speciality medical clinics ( family practice, neurology, internal medicine, pain management)
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.
Mark Sostek, MD
AstraZeneca
Karin S Coyne, PHD, MPH
United BioSource
79 participants (actual enrollment reported by the registry).
First Submitted
July 12, 2012
First Posted
July 20, 2012
Study Start
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
Contact the study team to confirm eligibility.
Primary Completion
February 2013
Actual (reported)Study Completion
February 2013
Actual (reported)Last Updated
October 20, 2014
Record last verified: 2014-10
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Source: ClinicalTrials.gov.
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