Chronic Idiopathic ConstipationPhase 4NCT01460225
Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation
A Phase 4 study testing lubiprostone in people with Chronic Idiopathic Constipation, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
This prospective study is designed to evaluate how lubiprostone may affect gastric motor and sensory function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Idiopathic Constipation
- What is being tested?
- lubiprostone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jan 2011
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic idiopathic constipation
Who cannot join
- medications that slow gastrointestinal (GI) motility
- prior surgery to the GI tract
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: Effects of Lubiprostone on Gastric Sensory and Motor Function in Patients With Chronic Idiopathic Constipation
This prospective study is designed to evaluate how lubiprostone may affect gastric motor and sensory function.
- Conditions
- Chronic Idiopathic Constipation
- Being tested
- lubiprostone
- Keywords
- constipation, chronic idiopathic constipation, no prior history of surgery to the colon, not on any type of medication that could alter gastrointestinal motility or transit
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lubiprostoneDrug
24 micrograms twice daily for 1 week
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 24 micrograms of lubiprostone twice daily for one week. Receives: Drug: lubiprostone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Emptying
gastric emptying was measured before and after 7 days of treatment.at set times (2 and 4 hours post eating a radio-labeled meal)
Measured: Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startSep 2007
- Primary completionDec 2010
- Study completionJan 2011
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 Chronic Idiopathic ConstipationStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460225
- Sponsor's protocol ID
- 07-033L
- Status last verified
- Jul 2018
- First submitted
- 19 Jul 2010
- Last updated
- 13 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lubiprostone on Gastric Sensory and Motor Function in Patients With Chronic Idiopathic Constipation
- ClinicalTrials.gov ID
- NCT01460225
- Acronym / sponsor ID
- 07-033L
- Conditions
- Chronic Idiopathic Constipation
- Keywords
- constipation, chronic idiopathic constipation, no prior history of surgery to the colon, not on any type of medication that could alter gastrointestinal motility or transit
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Study start
- Sep 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 26 Oct 2011 (estimated)
- Results
- Posted 13 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective study is designed to evaluate how lubiprostone may affect gastric motor and sensory function.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: lubiprostone24 micrograms of lubiprostone twice daily for one week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic idiopathic constipation
Key exclusion criteria (2 listed)
- medications that slow gastrointestinal (GI) motility
- prior surgery to the GI tract
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 |
|---|---|---|
| lubiprostone24 micrograms twice daily for 1 week | Drug | Treatment |
Primary outcome
Gastric Emptying
Time frame: Day 1 and Day 7
gastric emptying was measured before and after 7 days of treatment.at set times (2 and 4 hours post eating a radio-labeled meal)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lubiprostone in people with Chronic Idiopathic Constipation, run by Dartmouth-Hitchcock Medical Center 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 13 Jul 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2018). 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?
Gastric Emptying (time frame: Day 1 and Day 7). 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 13 Jul 2018.