ConstipationNCT00669461
Lubiprostone as a Treatment for Constipation in Parkinson's Disease
A study testing Lubiprostone in people with Constipation and Parkinson's Disease, run by University of Arkansas at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Constipation, Parkinson's Disease
- What is being tested?
- Lubiprostone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50-85 years
- Diagnosis of Parkinson's disease
- Constipation as defined by the Rome III committee
- BSFS of more or equal to 1 and less or equal to 3
- Normal colonoscopy in the last 5 years( normal defined as absence of obstructive lesions in the colon)
- All women subjects will be post menopausal or surgically sterile.
Who cannot join
- Known hypersensitivity reaction to Amitiza ( Lubiprostone)
- Known significant adverse effects to previous treatment with Lubiprostone which include; new or worsening abdominal pain, severe diarrhea, nausea, vomiting, and severe headache.
- Renal dysfunction with creatinine clearance less than 15 ml/min
- Abnormal liver enzymes or history of chronic liver disorder
- History of bowel obstruction, , or abdominal adhesions .
- Abnormal Colonoscopy ( obstructive lesions within the colon)
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
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:
- Lubiprostone will improve ratings on the Bristol stool form scale (BSFS) in patients with PD induced constipation compared to baseline.(primary)
- Lubiprostone will increase the number of spontaneous bowel movements (SBM) per week, compared to baseline. (secondary)
- Lubiprostone will improve health related quality of life in subjects with PD induced constipation. ( secondary)
- Conditions
- Constipation, Parkinson's Disease
- Being tested
- Lubiprostone
- Keywords
- Constipation, Parkinson's Disease
- Medical subject headings
- Constipation, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LubiprostoneDrug
Lubiprostone 24 mcg BID orally for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Drug: Lubiprostone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 6 weeks
Secondary outcomes (1)
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)).
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2008 (estimated)
- Study startJun 2009
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor
- Investigators
- Muhannad M Heif, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669461
- Sponsor's protocol ID
- 78055
- Other IDs
- 78055, FWA00001119
- Status last verified
- Nov 2016
- First submitted
- 28 Apr 2008
- Last updated
- 30 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lubiprostone as a Treatment for Constipation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00669461
- Acronym / sponsor ID
- 78055
- Conditions
- Constipation, Parkinson's Disease
- Keywords
- Constipation, Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- Jun 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 30 Apr 2008 (estimated)
- Results
- Posted 15 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Lubiprostone will improve ratings on the Bristol stool form scale (BSFS) in patients with PD induced constipation compared to baseline.(primary)
- Lubiprostone will increase the number of spontaneous bowel movements (SBM) per week, compared to baseline. (secondary)
- Lubiprostone will improve health related quality of life in subjects with PD induced constipation. ( secondary)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Drug: Lubiprostone |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 50-85 years
- Diagnosis of Parkinson's disease
- Constipation as defined by the Rome III committee
- BSFS of more or equal to 1 and less or equal to 3
- Normal colonoscopy in the last 5 years( normal defined as absence of obstructive lesions in the colon)
Key exclusion criteria (7 listed)
- Known hypersensitivity reaction to Amitiza ( Lubiprostone)
- Known significant adverse effects to previous treatment with Lubiprostone which include; new or worsening abdominal pain, severe diarrhea, nausea, vomiting, and severe headache.
- Renal dysfunction with creatinine clearance less than 15 ml/min
- Abnormal liver enzymes or history of chronic liver disorder
- History of bowel obstruction, , or abdominal adhesions .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LubiprostoneLubiprostone 24 mcg BID orally for 4 weeks | Drug | Patients |
Primary outcome
Average Bristol Stool Form Scale (BSFS) at Baseline, End of 4 Weeks and End of 6 Weeks
Time frame: 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).
1 secondary outcome
Average Number of Spontaneous Bowel Movements (SBM) Per Week
Time frame: up to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhannad M Heif, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lubiprostone in people with Constipation and Parkinson's Disease, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Bristol Stool Form Scale (BSFS) at Baseline, End of 4 Weeks and End of 6 Weeks (time frame: up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2016.