Trial Outcomes & Findings for Amitiza in Constipation Associated With PD (Parkinson's Disease) (NCT NCT00908076)

Results Overview

Global impression of change, stool diary, visual analog scale of improvement, UPDRS rating scale and constipation questionnaires. The primary efficacy data will be analyzed using Student's t-test with unequal variances as the difference from baseline in SBM comparing cases and controls, using last observation carried forward for missing data in the intent-to-treat population.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

78 participants

Primary outcome timeframe

Baseline to end of study

Results posted on

2022-12-29

Participant Flow

Participant milestones

Participant milestones
Measure	Amitiza LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.	Placebo LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
Overall Study STARTED	27	27
Overall Study COMPLETED	26	26
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Amitiza LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.	Placebo LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
Overall Study Lack of Efficacy	1	1

Baseline Characteristics

Amitiza in Constipation Associated With PD (Parkinson's Disease)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Amitiza n=27 Participants LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.	Placebo n=27 Participants LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.	Total n=54 Participants Total of all reporting groups
Age, Continuous	67.3 years STANDARD_DEVIATION 8.1 • n=5 Participants	70.1 years STANDARD_DEVIATION 12.2 • n=7 Participants	68.0 years STANDARD_DEVIATION 10.15 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	27 participants n=7 Participants	54 participants n=5 Participants
PD duration	8.9 years STANDARD_DEVIATION 6.3 • n=5 Participants	9.5 years STANDARD_DEVIATION 6.3 • n=7 Participants	9.2 years STANDARD_DEVIATION 6.3 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to end of study

Population: A marked or very marked clinical global improvement. Ondo WG et al. Placebo-controlled trial of lubiprostone for constipation associated with Parkinson disease. Neurology 2012 May 22; 78:1650. - See more at: http://www.jwatch.org/jn201205290000006/2012/05/29/lubiprostone-constipation-parkinson-disease#sthash.ggWrS7Vq.dpuf

Global impression of change, stool diary, visual analog scale of improvement, UPDRS rating scale and constipation questionnaires. The primary efficacy data will be analyzed using Student's t-test with unequal variances as the difference from baseline in SBM comparing cases and controls, using last observation carried forward for missing data in the intent-to-treat population.

Outcome measures

Outcome measures
Measure	Amitiza n=27 Participants LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.	Placebo n=27 Participants LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
Change From Baseline to End of Study	64 Percentage of participants	18.5 Percentage of participants

Adverse Events

Amitiza

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Amitiza n=27 participants at risk LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=27) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.	Placebo n=27 participants at risk LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=27) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
Gastrointestinal disorders diarrhea	11.1% 3/27 • Number of events 3	3.7% 1/27 • Number of events 1

Additional Information

Christine Hunter

Baylor College of Medicine

Phone: 713-798-6556

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place