Trial Outcomes & Findings for Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients (NCT NCT01189409)
NCT ID: NCT01189409
Last Updated: 2019-08-28
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
Last 18 days of each 21 day study period
Results posted on
2019-08-28
Participant Flow
Participant milestones
| Measure |
PEG Then Senna
PEG in stepped bowel protocol
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).
|
Senna Then PEG
Stepped bowel protocol with Senna then PEG
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).
|
|---|---|---|
|
First 3 Weeks
STARTED
|
37
|
33
|
|
First 3 Weeks
COMPLETED
|
19
|
23
|
|
First 3 Weeks
NOT COMPLETED
|
18
|
10
|
|
Second 3 Weeks (Switch to 2nd Treatment)
STARTED
|
19
|
23
|
|
Second 3 Weeks (Switch to 2nd Treatment)
COMPLETED
|
13
|
15
|
|
Second 3 Weeks (Switch to 2nd Treatment)
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PEG Then Senna
n=37 Participants
PEG in stepped bowel protocol
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).
|
Senna Then PEG
n=33 Participants
Stepped bowel protocol with Senna then PEG
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).
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=70 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=37 Participants
|
22 Participants
n=33 Participants
|
42 Participants
n=70 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=37 Participants
|
11 Participants
n=33 Participants
|
28 Participants
n=70 Participants
|
|
Age, Continuous
|
72.8 years
n=37 Participants
|
59.2 years
n=33 Participants
|
66 years
n=70 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=37 Participants
|
15 Participants
n=33 Participants
|
38 Participants
n=70 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=37 Participants
|
18 Participants
n=33 Participants
|
32 Participants
n=70 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Diagnosis
Lung
|
4 Participants
n=37 Participants
|
6 Participants
n=33 Participants
|
10 Participants
n=70 Participants
|
|
Diagnosis
Breast
|
9 Participants
n=37 Participants
|
4 Participants
n=33 Participants
|
13 Participants
n=70 Participants
|
|
Diagnosis
GI
|
3 Participants
n=37 Participants
|
3 Participants
n=33 Participants
|
6 Participants
n=70 Participants
|
|
Diagnosis
Brain
|
1 Participants
n=37 Participants
|
0 Participants
n=33 Participants
|
1 Participants
n=70 Participants
|
|
Diagnosis
Kidney
|
1 Participants
n=37 Participants
|
0 Participants
n=33 Participants
|
1 Participants
n=70 Participants
|
|
Diagnosis
Prostate
|
3 Participants
n=37 Participants
|
3 Participants
n=33 Participants
|
6 Participants
n=70 Participants
|
|
Diagnosis
Bladder
|
1 Participants
n=37 Participants
|
0 Participants
n=33 Participants
|
1 Participants
n=70 Participants
|
|
Diagnosis
Haematological
|
3 Participants
n=37 Participants
|
5 Participants
n=33 Participants
|
8 Participants
n=70 Participants
|
|
Diagnosis
Other
|
12 Participants
n=37 Participants
|
12 Participants
n=33 Participants
|
24 Participants
n=70 Participants
|
PRIMARY outcome
Timeframe: Last 18 days of each 21 day study periodMean 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.
Outcome measures
| Measure |
Polyethylene Glycol (PEG)
n=28 Participants
Those patients on PEG during either treatment period
|
Sennosides
n=28 Participants
Those patients on sennosides during either treatment period
|
No Preference
Participants who completed both arms of the study and had no preference in treatment
|
|---|---|---|---|
|
Bowel Performance Scale (BPS)
Period 1
|
0.659 Ratio
Interval 0.0 to 0.941
|
0.534 Ratio
Interval 0.0 to 1.0
|
—
|
|
Bowel Performance Scale (BPS)
Period 2
|
0.641 Ratio
Interval 0.333 to 1.0
|
0.636 Ratio
Interval 0.111 to 1.0
|
—
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Polyethylene Glycol (PEG)
n=28 Participants
Those patients on PEG during either treatment period
|
Sennosides
n=28 Participants
Those patients on sennosides during either treatment period
|
No Preference
n=28 Participants
Participants who completed both arms of the study and had no preference in treatment
|
|---|---|---|---|
|
Patient Preference
|
13 Participants
|
13 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 weeks (ascertained at the end of period 1)Population: Patients with a minimum of 7 days of treatment in the first period were included in the modeling.
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.
Outcome measures
| Measure |
Polyethylene Glycol (PEG)
n=23 Participants
Those patients on PEG during either treatment period
|
Sennosides
n=24 Participants
Those patients on sennosides during either treatment period
|
No Preference
Participants who completed both arms of the study and had no preference in treatment
|
|---|---|---|---|
|
Time (in Days) to Attain an Ideal BPS Score of Goal
|
6 Days
Interval 4.0 to 13.0
|
8 Days
Interval 6.0 to
Only the lower bound could be computed
|
—
|
SECONDARY outcome
Timeframe: Last 18 days of each 21 day study periodPopulation: Patients who reported incidence of cramps at least once.
The patients were asked to indicate any experience of cramps while on study treatment
Outcome measures
| Measure |
Polyethylene Glycol (PEG)
n=70 Participants
Those patients on PEG during either treatment period
|
Sennosides
n=70 Participants
Those patients on sennosides during either treatment period
|
No Preference
Participants who completed both arms of the study and had no preference in treatment
|
|---|---|---|---|
|
Incidence of Cramps
|
27 Participants
|
25 Participants
|
—
|
SECONDARY outcome
Timeframe: Last 18 days of each 21 day study periodPopulation: Patients who reported incidence of rectal pain or rectal bleeding at least once.
The patients were asked to indicate any experience of rectal bleeding or rectal pain while on study treatment
Outcome measures
| Measure |
Polyethylene Glycol (PEG)
n=70 Participants
Those patients on PEG during either treatment period
|
Sennosides
n=70 Participants
Those patients on sennosides during either treatment period
|
No Preference
Participants who completed both arms of the study and had no preference in treatment
|
|---|---|---|---|
|
Rectal Measures
Rectal Bleeding
|
7 Participants
|
6 Participants
|
—
|
|
Rectal Measures
Rectal Pain
|
10 Participants
|
9 Participants
|
—
|
Adverse Events
Polyethylene Glycol (PEG)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Senna
Serious events: 0 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Polyethylene Glycol (PEG)
n=70 participants at risk
Patients on PEG during either treatment period
|
Senna
n=70 participants at risk
Patients on Senna during either treatment period
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
5.7%
4/70 • 6 weeks (the end of the second treatment period)
|
2.9%
2/70 • 6 weeks (the end of the second treatment period)
|
|
General disorders
Dysphagia
|
0.00%
0/70 • 6 weeks (the end of the second treatment period)
|
1.4%
1/70 • 6 weeks (the end of the second treatment period)
|
|
General disorders
Pain
|
0.00%
0/70 • 6 weeks (the end of the second treatment period)
|
1.4%
1/70 • 6 weeks (the end of the second treatment period)
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/70 • 6 weeks (the end of the second treatment period)
|
1.4%
1/70 • 6 weeks (the end of the second treatment period)
|
|
Gastrointestinal disorders
Cramps
|
0.00%
0/70 • 6 weeks (the end of the second treatment period)
|
1.4%
1/70 • 6 weeks (the end of the second treatment period)
|
|
General disorders
Dizziness
|
0.00%
0/70 • 6 weeks (the end of the second treatment period)
|
1.4%
1/70 • 6 weeks (the end of the second treatment period)
|
|
Product Issues
Allergic Reaction
|
1.4%
1/70 • 6 weeks (the end of the second treatment period)
|
0.00%
0/70 • 6 weeks (the end of the second treatment period)
|
|
General disorders
|
1.4%
1/70 • 6 weeks (the end of the second treatment period)
|
0.00%
0/70 • 6 weeks (the end of the second treatment period)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place