Trial Outcomes & Findings for Lubiprostone (Amitiza®) Vs. Standard Care in Opioid-induced Constipation After Surgery in Inpatient Rehabilitation (NCT NCT00662363)
NCT ID: NCT00662363
Last Updated: 2013-03-06
Results Overview
Patient Assessment of Constipation (PAC) - Change in this measure was assessed. The PAC has previously been found to be a valid and reliable way to measure constipation symptoms and clinical course. The PAC has two components. The symptom (SYM) component is composed of 12 items with score range 0-4 with lower scores indicating improvement. Scores within the two domains were separately averaged. The PAC-SYM questionnaire has shown good concurrent and clinical validity for opioid-induced constipation in a number of pain populations and has demonstrative responsiveness to treatment. There are three symptom domains within the PAC-SYM: Abdominal symptoms (4 items), rectal symptoms (3 items) and stool symptoms (5 items).
COMPLETED
NA
64 participants
Baseline and Day 7, after treatment completed (6 days of treatment)
2013-03-06
Participant Flow
Participants were recruited from the inpatient population of an academic freestanding rehabilitation hospital following admission for impairments related to an orthopedic surgery.The study was approved by the local institutional review board and all subjects provided written informed consent.
72 patients were recruited. There were eight who did not meet inclusion and/or exclusion criteria following consent and screening visit. Reasons for exclusion were: history of Crohn's disease (1 person), history of irritable bowel disease (1 person), diarrhea on baseline visit day (1 person), or no associated bowel symptom (5 persons).
Participant milestones
| Measure |
Lubiprostone
Lubiprostone24 µg po BID for 6 days with placebo senna tab
|
Senna
Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
21
|
22
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
Reasons for withdrawal
| Measure |
Lubiprostone
Lubiprostone24 µg po BID for 6 days with placebo senna tab
|
Senna
Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Discharged early from rehab
|
4
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Lubiprostone (Amitiza®) Vs. Standard Care in Opioid-induced Constipation After Surgery in Inpatient Rehabilitation
Baseline characteristics by cohort
| Measure |
Lubiprostone
n=32 Participants
Lubiprostone24 µg po BID for 6 days with placebo senna tab
|
Senna
n=32 Participants
Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Age Continuous
|
70.9 years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
72.2 years
STANDARD_DEVIATION 10.5 • n=107 Participants
|
71.6 years
STANDARD_DEVIATION 11.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=99 Participants
|
32 participants
n=107 Participants
|
64 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 7, after treatment completed (6 days of treatment)Population: All subjects randomized and who had baseline and endpoint data were included in the intention to treat analysis.
Patient Assessment of Constipation (PAC) - Change in this measure was assessed. The PAC has previously been found to be a valid and reliable way to measure constipation symptoms and clinical course. The PAC has two components. The symptom (SYM) component is composed of 12 items with score range 0-4 with lower scores indicating improvement. Scores within the two domains were separately averaged. The PAC-SYM questionnaire has shown good concurrent and clinical validity for opioid-induced constipation in a number of pain populations and has demonstrative responsiveness to treatment. There are three symptom domains within the PAC-SYM: Abdominal symptoms (4 items), rectal symptoms (3 items) and stool symptoms (5 items).
Outcome measures
| Measure |
Lubiprostone
n=28 Participants
Lubiprostone24 µg po BID for 6 days with placebo senna tab
|
Senna
n=28 Participants
Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
|
|---|---|---|
|
Change in Patient Assessment of Constipation (PAC) - Symptoms (Sym)
|
-0.22 units on a scale
Standard Deviation 0.57
|
-0.29 units on a scale
Standard Deviation 0.58
|
PRIMARY outcome
Timeframe: Baseline and day 7Population: intention to treat
The second component of the PAC is the quality of life (QOL) component.The quality of life (QOL) component consists of five items that are rated on a 0-4 scale with higher scores indicating better QOL. Scores within the domains are averaged.
Outcome measures
| Measure |
Lubiprostone
n=28 Participants
Lubiprostone24 µg po BID for 6 days with placebo senna tab
|
Senna
n=28 Participants
Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
|
|---|---|---|
|
Change in Patient Assessment of Constipation - Quality of Life
|
0.99 units on a scale
Standard Deviation 0.78
|
.42 units on a scale
Standard Deviation 0.84
|
Adverse Events
Lubiprostone
Senna
Serious adverse events
| Measure |
Lubiprostone
n=31 participants at risk
Lubiprostone24 µg po BID for 6 days with placebo senna tab
|
Senna
n=29 participants at risk
Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
patellar dislocation
|
3.2%
1/31 • Number of events 1
|
0.00%
0/29
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/31
|
3.4%
1/29 • Number of events 1
|
Other adverse events
| Measure |
Lubiprostone
n=31 participants at risk
Lubiprostone24 µg po BID for 6 days with placebo senna tab
|
Senna
n=29 participants at risk
Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
41.9%
13/31 • Number of events 22
|
27.6%
8/29 • Number of events 16
|
|
Nervous system disorders
Headache
|
0.00%
0/31
|
3.4%
1/29 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/31
|
3.4%
1/29 • Number of events 1
|
|
Blood and lymphatic system disorders
Increased INR
|
0.00%
0/31
|
3.4%
1/29 • Number of events 1
|
Additional Information
Christina Marciniak
Rehabilitation Institute of Chicago
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place