A Randomized, Double Blind, Double-dummy, 2-treatment, 2-period Crossover Comparison of Sennosides and Polyethylene Glycol in Treatment of Opioid-induced Constipation in Outpatients With Cancer
One group will be started on a bowel protocol of escalating doses of sennosides, plus a
dummy polyethylene glycol (lactose), and the other will receive dummy sennosides capsules
(lactose)plus polyethylene glycol, with the same dosing protocol. After three weeks the
patients will switch to the alternate active product and dummy preparation. The total
duration for the study will be 6 weeks for each patient.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Bowel Performance Scale (BPS)
The proportion of days in which the BPS is within the range -1 to +1 wll be compared between treatment periods
Last 18 days of each 21 day study period
No
Philippa Hawley, FRCPC
Principal Investigator
British Columbia Cancer Agency
Canada: Health Canada
H0901329
NCT01189409
June 2010
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