ConstipationPhase 4NCT01189409
Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients
A Phase 4 study testing PEG then Senna and Senna then PEG in people with Constipation and Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
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 British Columbia Cancer Pain and Symptom Management/Palliative Care clinics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation, Cancer
- What is being tested?
- PEG then Senna and Senna then PEG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2010to Oct 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (18 years and above) with diagnosis of cancer.
- Patient requires treatment or prevention of constipation.
- Patient is able to communicate effectively with staff.
- Expected prognosis more than 12 weeks.
- On or starting opioid therapy
Who cannot join
- Patient unable to take oral medication.
- Allergy or previous intolerance to PEG or sennosides.
- Lactose intolerant.
- Contraindication to PEG or sennosides.
- Known or suspected bowel obstruction or ileus.
- Colostomy or ileostomy.
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- Inflammatory bowel disease.
- Hospitalisation expected within the study period.
- Patient unable to complete the study diary in English.
Trial locations and contacts
1 site in 1 country.
About this study
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
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 British Columbia Cancer Pain and Symptom Management/Palliative Care clinics. Each participating patient will be randomly assigned to one of two treatment groups.
Read the detailed description
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 of one active treatment 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.
- Conditions
- Constipation, Cancer
- Being tested
- PEG then Senna, Senna then PEG
- Keywords
- Constipation, Opioids, Cancer, Polyethylene glycol, Sennosides, Opioid Therapy
- Medical subject headings
- Constipation, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG then SennaDrug
Also called Lax-a-Day
Stepped bowel protocol with PEG for 3 weeks followed by senna for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder).
Senna then PEGDrug
Also called senokot
Stepped bowel protocol with senna for 3 weeks followed by PEG for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder).
| Study group | Role | What they receive |
|---|---|---|
| PEG then Senna | Experimental | PEG in stepped bowel protocol Receives: Drug: PEG then Senna |
| Senna then PEG | Experimental | Stepped bowel protocol with Senna then PEG Receives: Drug: Senna then PEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel Performance Scale (BPS)
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.
Measured: Last 18 days of each 21 day study period
Secondary outcomes (4)
Patient Preference
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).
Measured: end of study (6 weeks)
Time (in Days) to Attain an Ideal BPS Score of Goal
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.
Measured: 3 weeks (ascertained at the end of period 1)
Incidence of Cramps
The patients were asked to indicate any experience of cramps while on study treatment
Measured: Last 18 days of each 21 day study period
Rectal Measures
The patients were asked to indicate any experience of rectal bleeding or rectal pain while on study treatment
Measured: Last 18 days of each 21 day study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2017
- Study completionOct 2018
Why it stopped: This study was terminated based on results of interim analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pippa Hawley, British Columbia Cancer Agency
- Investigators
- Philippa Hawley, FRCPC, Principal investigator, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189409
- Sponsor's protocol ID
- H0901329
- Status last verified
- Aug 2019
- First submitted
- 17 Mar 2010
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01189409
- Acronym / sponsor ID
- H0901329
- Conditions
- Constipation, Cancer
- Keywords
- Constipation, Opioids, Cancer, Polyethylene glycol, Sennosides, Opioid Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated based on results of interim analysis.
- Enrolment
- 70 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2017 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 26 Aug 2010 (estimated)
- Results
- Posted 19 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 British Columbia Cancer Pain and Symptom Management/Palliative Care clinics. Each participating patient will be randomly assigned to one of two treatment groups.
Detailed description
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 of one active treatment 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PEG then Senna | Experimental | Drug: PEG then SennaPEG in stepped bowel protocol |
| Senna then PEG | Experimental | Drug: Senna then PEGStepped bowel protocol with Senna then PEG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patient (18 years and above) with diagnosis of cancer.
- Patient requires treatment or prevention of constipation.
- Patient is able to communicate effectively with staff.
- Expected prognosis more than 12 weeks.
- On or starting opioid therapy
Key exclusion criteria (9 listed)
- Patient unable to take oral medication.
- Allergy or previous intolerance to PEG or sennosides.
- Lactose intolerant.
- Contraindication to PEG or sennosides.
- Known or suspected bowel obstruction or ileus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG then SennaAlso: Lax-a-DayStepped bowel protocol with PEG for 3 weeks followed by senna for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder). | Drug | PEG then Senna |
| Senna then PEGAlso: senokotStepped bowel protocol with senna for 3 weeks followed by PEG for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder). | Drug | Senna then PEG |
Primary outcome
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.
4 secondary outcomes
Patient Preference
Time frame: end of study (6 weeks)
Time (in Days) to Attain an Ideal BPS Score of Goal
Time frame: 3 weeks (ascertained at the end of period 1)
Incidence of Cramps
Time frame: Last 18 days of each 21 day study period
Rectal Measures
Time frame: Last 18 days of each 21 day study period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippa Hawley, FRCPC principal investigator
British Columbia Cancer Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PEG then Senna and Senna then PEG in people with Constipation and Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel Performance Scale (BPS) (time frame: Last 18 days of each 21 day study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.