Irritable Bowel SyndromePhase 1NCT01166789
Lubiprostone Effects on Visceral Pain Sensitivity
A Phase 1 study testing Lubiprostone in people with Irritable Bowel Syndrome, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this research study is to determine how Lubiprostone, a medication used to treat irritable bowel syndrome with constipation predominant symptoms (IBS-C), works to reduce clinical pain. Lubiprostone acts in the small intestine to cause an increase in the secretion of chloride, water and sodium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Lubiprostone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Aug 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- clinical diagnosis of IBS-C
- meeting Rome III diagnostic criteria for IBS-C
- age 18 or older
Who cannot join
- use of laxatives or prokinetics within two weeks prior to the study or during the study
- use of IBS-specific compounds, opiates, anticholinergics, or any drug likely to cause constipation as a side-effect
- use of analgesics for 48 hours prior to the study
- hypothyroid condition
- history of bowel resection except appendectomy or cholecystectomy
- psychotic disorder, major depression, substance abuse (other than tobacco), or other psychiatric condition likely to interfere with the conduct of the study. Subjects treated for depression more than 2 years ago or for situational circumstances may be eligible for the study at the investigator's discretion
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- renal disease
- inflammatory or ischemic disease of the rectum
- known to be an unreliable subject
- Because this study involves exposure to radiation, subjects who are pregnant or planning to become pregnant, employees currently working with radiation, and subjects who have participated in research involving radiation within the past year will also be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Clinical and Translational Research Center
Chapel Hill, North Carolina, 27599
About this study
The purpose of this research study is to determine how Lubiprostone, a medication used to treat irritable bowel syndrome with constipation predominant symptoms (IBS-C), works to reduce clinical pain. Lubiprostone acts in the small intestine to cause an increase in the secretion of chloride, water and sodium. The increased fluid causes food residue to move through the bowel more quickly and makes the stools softer. First, we want to test the idea that Lubiprostone works by making a person less sensitive to pain. Second, we want to confirm that Lubiprostone decreases the time it takes fecal matter to travel through your GI tract, referred to as transit time.
Read the detailed description
Subjects will be enrolled in an 8-week study requiring a total of 7 visits to the UNC Center for Clinical and Translational Research. The protocol is divided into 4 two-week periods: (1) Two-week baseline diary symptom monitoring, followed by a barostat test of pain sensitivity. (2) Two-week treatment with either Lubiprostone or placebo, with daily symptom diary recording and barostat test of pain sensitivity at the end. In addition, patients will be tested for whole gut transit time by the radio-opaque marker (Sitzmark) technique in the second week. (3) Two-week washout period, during which patients will continue the symptom diary. (4) Two-week crossover to Lubiprostone or placebo, identical to the second two-week period.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Lubiprostone, Placebo
- Keywords
- IBS, pain threshold, constipation
- Medical subject headings
- Irritable Bowel Syndrome, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LubiprostoneDrug
Also called Amitiza
48ug daily taken as 24ug capsules twice per day, in morning and evening.
PlaceboDrug
2 capsules daily, taken in morning and evening
| Study group | Role | What they receive |
|---|---|---|
| Lubiprostone | Active comparator | Lubiprostone 48ug taken daily for 14 days. Receives: Drug: Lubiprostone |
| Placebo | Placebo comparator | 2 capsules containing a substance with no active ingredient taken daily for 14 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain threshold
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startFeb 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Principal investigator, William Whitehead, PhD, University of North Carolina, Chapel Hill
- Investigators
- William E Whitehead, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166789
- Sponsor's protocol ID
- 07-004L
- Status last verified
- Sep 2011
- First submitted
- 19 Jul 2010
- Last updated
- 16 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lubiprostone Effects on Visceral Pain Sensitivity
- ClinicalTrials.gov ID
- NCT01166789
- Acronym / sponsor ID
- 07-004L
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, pain threshold, constipation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- Feb 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine how Lubiprostone, a medication used to treat irritable bowel syndrome with constipation predominant symptoms (IBS-C), works to reduce clinical pain. Lubiprostone acts in the small intestine to cause an increase in the secretion of chloride, water and sodium. The increased fluid causes food residue to move through the bowel more quickly and makes the stools softer. First, we want to test the idea that Lubiprostone works by making a person less sensitive to pain. Second, we want to confirm that Lubiprostone decreases the time it takes fecal matter to travel through your GI tract, referred to as transit time.
Detailed description
Subjects will be enrolled in an 8-week study requiring a total of 7 visits to the UNC Center for Clinical and Translational Research. The protocol is divided into 4 two-week periods: (1) Two-week baseline diary symptom monitoring, followed by a barostat test of pain sensitivity. (2) Two-week treatment with either Lubiprostone or placebo, with daily symptom diary recording and barostat test of pain sensitivity at the end. In addition, patients will be tested for whole gut transit time by the radio-opaque marker (Sitzmark) technique in the second week. (3) Two-week washout period, during which patients will continue the symptom diary. (4) Two-week crossover to Lubiprostone or placebo, identical to the second two-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lubiprostone | Active comparator | Drug: LubiprostoneLubiprostone 48ug taken daily for 14 days. |
| Placebo | Placebo comparator | Drug: Placebo2 capsules containing a substance with no active ingredient taken daily for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of IBS-C
- meeting Rome III diagnostic criteria for IBS-C
- age 18 or older
Key exclusion criteria (10 listed)
- use of laxatives or prokinetics within two weeks prior to the study or during the study
- use of IBS-specific compounds, opiates, anticholinergics, or any drug likely to cause constipation as a side-effect
- use of analgesics for 48 hours prior to the study
- hypothyroid condition
- history of bowel resection except appendectomy or cholecystectomy
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 |
|---|---|---|
| LubiprostoneAlso: Amitiza48ug daily taken as 24ug capsules twice per day, in morning and evening. | Drug | Lubiprostone |
| Placebo2 capsules daily, taken in morning and evening | Drug | Placebo |
Primary outcome
Pain threshold
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2011.
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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.
William E Whitehead, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lubiprostone in people with Irritable Bowel Syndrome, run by University of North Carolina, Chapel Hill 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 3 inclusion and 10 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 16 Sep 2011. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain threshold (time frame: 2 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 16 Sep 2011.