Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients
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|ClinicalTrials.gov Identifier: NCT01189409|
Recruitment Status : Terminated (This study was terminated based on results of interim analysis.)
First Posted : August 26, 2010
Results First Posted : October 19, 2018
Last Update Posted : August 28, 2019
|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 :||70 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|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||October 2018|
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 ]Mean values of Number of Days with Satisfactory Bowel Movements Per Days of Treatment across time by treatment, derived from the mixed effects Poisson regression model. If the BPS rating on a day was -1, 0 or +1, the patient's bowel movement on that day was deemed to be satisfactory.
- Patient Preference [ Time Frame: end of study (6 weeks) ]The patients will be asked to state which treatment period they prefer. Only assessed using patients who completed both arms of the study (n=28).
- Time (in Days) to Attain an Ideal BPS Score of Goal [ Time Frame: 3 weeks (ascertained at the end of period 1) ]
Proportion of patients in the study population estimated to reach a BPS at goal in the first period as a function of the time (in days) from day 1, presuming they were followed for 21 days and contributed a BPS score on each of those days.
Constipation was graded using the Victoria Bowel Performance Scale (BPS), a nine-point scale from -4 (constipation) to +4 (diarrhea) which has been validated for use in patients receiving palliative care.
- Incidence of Cramps [ Time Frame: Last 18 days of each 21 day study period ]The patients were asked to indicate any experience of cramps while on study treatment
- Rectal Measures [ Time Frame: Last 18 days of each 21 day study period ]The patients were asked to indicate any experience of rectal bleeding or rectal pain while on study treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|