Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients
This is a study to compare the efficacy and tolerability of two laxatives for treatment of opioid-induced constipation in adult outpatients with cancer treated at the BC Cancer Agency Pain and Symptom Management/Palliative Care clinics. Each participating patient will be randomly assigned to one of two treatment groups.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||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|
- Bowel Performance Scale (BPS) [ Time Frame: Last 18 days of each 21 day study period ] [ Designated as safety issue: No ]The proportion of days in which the BPS is within the range -1 to +1 wll be compared between treatment periods
- Patient preference [ Time Frame: end of study (6 weeks) ] [ Designated as safety issue: No ]The patients will be asked to state which treament period they prefer
|Study Start Date:||June 2010|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: PEG then Senna
PEG in stepped bowel protocol
Drug: PEG then Senna
Stepped bowel protocol with PEG for 3 weeks followed by senna for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder).
Other Name: Lax-a-Day
Experimental: Senna then PEG
Stepped bowel protocol with Senna then PEG
Drug: Senna then PEG
Stepped bowel protocol with senna for 3 weeks followed by PEG for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder).
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.
|Contact: Philippa Hawley, FRCPC||604-866-6000 ext firstname.lastname@example.org|
|Contact: Brenda Ng||604-866-6000 ext email@example.com|
|Canada, British Columbia|
|BC Cancer Agency||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Contact: P Hawley, B.Med FRCPC 604-877-6000 ext 2707 firstname.lastname@example.org|
|Principal Investigator: Philippa Hawley, FRCPC|
|Principal Investigator:||Philippa Hawley, FRCPC||British Columbia Cancer Agency|