Constipation, Parkinson's Disease
Conditions
Keywords
Constipation, Parkinson's Disease
Brief summary
Delayed colonic transient time secondary to a multi-degenerative process is the most likely cause of constipation in idiopathic PD. Since lubiprostone demonstrated its ability to accelerate colonic transit time in healthy volunteers in addition to activating the chloride channels in the intestinal cells, it has the potential to improve constipation in patients with PD with no subsequent adverse events on the control of the neurological manifestation of PD. So we hypothesize the following: 1. Lubiprostone will improve ratings on the Bristol stool form scale (BSFS) in patients with PD induced constipation compared to baseline.(primary) 2. Lubiprostone will increase the number of spontaneous bowel movements (SBM) per week, compared to baseline. (secondary) 3. Lubiprostone will improve health related quality of life in subjects with PD induced constipation. ( secondary)
Interventions
DRUGLubiprostone
Lubiprostone 24 mcg BID orally for 4 weeks
Sponsors
Takeda
University of Arkansas
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age 50-85 years 2. Diagnosis of Parkinson's disease 3. Constipation as defined by the Rome III committee 4. BSFS of more or equal to 1 and less or equal to 3 5. Normal colonoscopy in the last 5 years( normal defined as absence of obstructive lesions in the colon) 6. All women subjects will be post menopausal or surgically sterile.
Exclusion criteria
1. Known hypersensitivity reaction to Amitiza ( Lubiprostone) 2. Known significant adverse effects to previous treatment with Lubiprostone which include; new or worsening abdominal pain, severe diarrhea, nausea, vomiting, and severe headache. 3. Renal dysfunction with creatinine clearance less than 15 ml/min 4. Abnormal liver enzymes or history of chronic liver disorder 5. History of bowel obstruction, , or abdominal adhesions . 6. Abnormal Colonoscopy ( obstructive lesions within the colon) 7. Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Bristol Stool Form Scale (BSFS) at Baseline, End of 4 Weeks and End of 6 Weeks | up to 6 weeks | The average BSFS will be determined at baseline (prior to the start lubiprostone) and compared with average rating of BSFS at end of the 4 weeks of treatment with Lubiprostone and at end of 2 weeks after stopping the Lubiprostone. BSFS is scale between 1-7, it measured the shape of the stool. BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool. Measure was reported at end of week #1-Baseline-,end of Week #5 ( after taking the lubiprostone for 4 weeks) and end of week # 7 ( end of 2 weeks after stopping the Lubiprostone). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Number of Spontaneous Bowel Movements (SBM) Per Week | up to 6 weeks | Average number of spontaneous bowel movements (SBM) per week,measured at baseline, at end of 4 weeks of treatment with Lubiprostone and at 2 weeks after stopping Lubiprostone (( so measure was reported at end of week # 1-Baseline-,end of Week #5 ( after taking the lubiprostone for 4 weeks) and end of week # 7 ( end of 2 weeks after stopping the Lubiprostone)). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lubiprostone patient received treatment( lubiprostone)24 mcg po BID for 4 weeks | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Lubiprostone |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 73 years STANDARD_DEVIATION 0 |
| Gender Female | 0 Participants |
| Gender Male | 1 Participants |
| Region of Enrollment United States | 1 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Average Bristol Stool Form Scale (BSFS) at Baseline, End of 4 Weeks and End of 6 Weeks
The average BSFS will be determined at baseline (prior to the start lubiprostone) and compared with average rating of BSFS at end of the 4 weeks of treatment with Lubiprostone and at end of 2 weeks after stopping the Lubiprostone. BSFS is scale between 1-7, it measured the shape of the stool. BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool. Measure was reported at end of week #1-Baseline-,end of Week #5 ( after taking the lubiprostone for 4 weeks) and end of week # 7 ( end of 2 weeks after stopping the Lubiprostone).
Time frame: up to 6 weeks
Population: Analysis was not performed for this outcome measure secondary to the small sample size ( one patient)
Secondary
Average Number of Spontaneous Bowel Movements (SBM) Per Week
Average number of spontaneous bowel movements (SBM) per week,measured at baseline, at end of 4 weeks of treatment with Lubiprostone and at 2 weeks after stopping Lubiprostone (( so measure was reported at end of week # 1-Baseline-,end of Week #5 ( after taking the lubiprostone for 4 weeks) and end of week # 7 ( end of 2 weeks after stopping the Lubiprostone)).
Time frame: up to 6 weeks
Population: Analysis was not performed for this outcome measure secondary to the small sample size ( one patient.