A Phase 4 interventional study of LUBIPROSTONE in Parkinson's Disease, sponsored by Baylor College of Medicine. Completed at 2 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-12-29.
Sponsored by Baylor College of Medicine · Phase 4, Interventional, and Treatment
The purpose of this study is to determine if Amitiza (lubiprostone), a drug proven to be safe and effective for chronic constipation, will also improve constipation symptoms in Parkinson's Disease patients. We will also evaluate the impact of the drug on changes in bowel movement consistency, quality of life and motor symptoms.
Parkinson's disease (PD) affects about one million people in the United States. It is a common neurological condition that is clinically defined by rigidity (muscle stiffness), bradykinesia (slowness of movement) and tremor. Parkinson's Disease , however, reveals numerous non-motor symptoms that have been underemphasized. Problematic symptoms include varying degrees of dementia, psychosis, diminished assertiveness and confidence, general fatigue, excessive daytime sleepiness, problems with blood pressure, sweating, and bladder, and a common yet difficult to define sense of "not feeling well".
A commonly missed symptom in Parkinson's patients is constipation. Constipation can be difficult to treat with current medications available and many are ineffective. Levodopa and dopamine agonists drugs are useful for motor symptoms in Parkinson's Disease but have no effect on constipation. Laxatives and enemas provide limited relief with bothersome side effects. Even fewer drugs have been studied targeting the constipation problem specifically in the Parkinson's Disease population. Lubiprostone (AMITIZA) is a new medication that has been studied in the general population for the treatment of chronic constipation. It has been shown to be a safe and effective medication with few side effects. Lubiprostone has not yet been studied in the Parkinson's Disease population. We hope to show that this medication can be safe and effective for constipation in PD patients as well.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 78 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
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Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
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Exclusion Criteria:
Amitiza
Drug: LUBIPROSTONE
Matching Placebo
Drug: 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
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.
Time frame: Baseline to end of study
| Milestone | Amitiza | Placebo |
|---|---|---|
| Started | 27 | 27 |
| Completed | 26 | 26 |
| Not completed | 1 | 1 |
| Withdrew: Lack of efficacy | 1 | 1 |
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.
| Percentage of participants | Amitiza | Placebo |
|---|---|---|
| Change From Baseline to End of Study | 64 | 18.5 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Amitiza | — | 0/27 (0%) | 3/27 (11.1%) |
| Placebo | — | 0/27 (0%) | 1/27 (3.7%) |
| Event | Amitiza | Placebo |
|---|---|---|
| diarrheaGastrointestinal disorders | 3/27 | 1/27 |
Patients were included if they had PD using standard criteria, were aged 35 to 85 years, and met the ROME II criteria19 and scored at least 10 on the ROME II constipation assessment. Excluded if they had any other identifiable cause of constipation, use of opioids, anticholinergic agents, or antacids containing magnesium or aluminum salts.
| Age, Continuous(years) | Amitiza | Placebo | Total |
|---|---|---|---|
| Mean | 67.3 ± 8.1 | 70.1 ± 12.2 | 68.0 ± 10.15 |
| Sex: Female, Male(Participants) | Amitiza | Placebo | Total |
|---|---|---|---|
| Female | 7 | 8 | 15 |
| Male | 20 | 19 | 39 |
| Region of Enrollment(participants) | Amitiza | Placebo | Total |
|---|---|---|---|
| United States | 27 | 27 | 54 |
| PD duration(years) | Amitiza | Placebo | Total |
|---|---|---|---|
| Mean | 8.9 ± 6.3 | 9.5 ± 6.3 | 9.2 ± 6.3 |
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Baylor College of Medicine