Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients
|ClinicalTrials.gov Identifier: NCT01189409|
Recruitment Status : Suspended (This study has been suspended because of staffing issues and pending review.)
First Posted : August 26, 2010
Last Update Posted : December 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Constipation Cancer||Drug: PEG then Senna Drug: Senna then PEG||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||
The primary outcome will be treated as a binomial outcome, expressed as the number of successful trials out of a pre-defined number of trials n = 18. Given this, the primary outcome will be analysed via a generalized mixed effects model. The model will include: (i) fixed effects for treatment, treatment period and their interaction, (ii) fixed effects for the baseline characteristics and (iii) a random patient effect. Including the latter effect in the model will help capture the within-patient correlation among the values of the primary outcome collected in Period I and Period II for the same patient.
All statistical analyses will be conducted using the open-source statistical software package R.
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Double blind using a dummy alternate treatment.|
|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|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2019|
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).
Other Name: senokot
- Bowel Performance Scale (BPS) [ Time Frame: Last 18 days of each 21 day study period ]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) ]The patients will be asked to state which treament period they prefer
- Time (in days) to attain an ideal BPS score of Goal (patient's goal) [ Time Frame: 3 weeks (ascertained at the end of period 1) ]The time will be evaluated from Day 4 onward, since the first 3 days will be part of the washout period.
- rectal measures and incidence of cramps [ Time Frame: last 18 days of each study period ]The patients will be asked to indicate suppository use and experience of cramps while on study treatment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189409
|Canada, British Columbia|
|BC Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Principal Investigator:||Philippa Hawley, FRCPC||British Columbia Cancer Agency|