HealthyPhase 4NCT00953043
Lubiprostone, Colonic Motility and Sensation
A Phase 4 study testing lubiprostone and Bowel preparation in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to evaluate the effects of lubiprostone, a drug approved and used for constipation, on pattern of contractions of the colon and the colon's sensitivity to distension. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- lubiprostone and Bowel preparation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jul 2009
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects
- Body mass index (BMI): 18 to 32.
- Negative pregnancy test for women of childbearing potential.
- Absence of gastrointestinal symptoms (abridged Bowel Disease Questionnaire).
- Signed informed consent.
Who cannot join
- Subjects with body mass index (BMI) of less than 18 or more than 32.
- Structural or metabolic diseases/conditions that affect the gastrointestinal (GI)system, or functional gastrointestinal disorders. For screening, the Bowel Disease Questionnaire will be used to exclude subjects with irritable bowel syndrome.
- Use of drugs or agents within the past 2 weeks that alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer antidepressants.
- NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection, and birth control pills or depot injections are permissible.
- Use of drugs or agents within the 2 weeks prior to screening that may add drowsiness and central nervous system (CNS) depression such as barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, antihistamines, muscle relaxants, other CNS depressants.
- Female subjects who are pregnant or breast feeding.
Show all 12Show fewer
- Females must be either surgically sterilized, postmenopausal (>12 months since last menses) or, if of childbearing potential, using reliable methods of contraception as determined by the physician (single-barrier methods alone and rhythm methods are not acceptable).
- Clinical evidence (including physical exam and ECG) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study. Any candidate participants with such disorder mentioned will be referred to their general physician.
- The Hospital Anxiety and Depression Scale (HADS) will be used to exclude subjects with significant affective disorders, as well as to determine anxiety and depression scores at the start of the study. Any candidate participants with such disorder mentioned will be referred to their general physician.
- Symptoms of a significant clinical illness in the two weeks prior to screening.
- Participation in another clinical study within the 30 days prior to screening.
- Subjects who are considered by the investigator to be alcoholics not in remission or known substance abusers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Lubiprostone, a Chloride Channel Activator, on Colonic Sensorimotor Functions in Healthy Subjects. A Phase IV, Placebo-Controlled, Parallel Group Study
This study is being done to evaluate the effects of lubiprostone, a drug approved and used for constipation, on pattern of contractions of the colon and the colon's sensitivity to distension.
Read the detailed description
This was a trial of healthy adults to compare the effects of oral lubiprostone, 24 microgram per day and placebo for three days, on sensation and contractions of the colon using validated methods.
On days 1 and 2, participants took the study medication with their breakfast and recorded the time. On day 2 starting at 4:00 pm, participants started a polyethylene glycol-based bowel preparation to cleanse the colon. After overnight bowl preparation, participants reported fasting to the study center at 7:00 am on day 3. Colonic sensorimotor functions were assessed by an endoscopically placed barostat-manometric assembly.
After 30 minutes of rest following tube placement, fasting colonic tone, colonic compliance and colonic sensation were tested. The last dose of medication was ingested and 1 hour later the same colonic functions, as well as colonic response to a standardized meal of a 1,000-kilocalorie chocolate milkshake were assessed. The participant was able to leave the study center in the afternoon, after a meal had been ingested (if desired).
Details on colonic tube placement: A flexible sigmoidoscopy was performed to evaluate the left side of the colon and to place a Teflon-coated guide wire beyond the splenic flexure. The colon was deflated as the sigmoidoscope was removed and a barostat catheter (constructed at Mayo Clinic, Rochester, MN) with six manometric point sensors and a polyethylene balloon was introduced into the colon over the guide wire. The barostat catheter was positioned in the mid-descending or upper sigmoid colon with the aid of fluoroscopy. The final position of the barostatically controlled balloon was confirmed by fluoroscopy. After the colonic tube placement, participants rested for 30 min. The catheter was connected to a rigid piston barostat machine. After transient inflation of the barostat bag to a volume of 75 ml to ensure it was unfolded, it was deflated. Thereafter, it was inflated in 2 mm Hg increments to baseline operating pressure, which was defined as 2 mm Hg above the minimal distension pressure at which respiratory excursions were clearly recorded by the barostat tracing.
- Conditions
- Healthy
- Being tested
- lubiprostone, Placebo, Bowel preparation
- Keywords
- lubiprostone, colon, motility, sensation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lubiprostoneDrug
Also called Amitiza
Lubiprostone 24 micrograms, one dose daily for three days in 30 subjects
PlaceboDrug
Placebo medication given for three days
Bowel preparationOther
Also called NuLytely
Polyethylene glycol-based bowel preparation
| Study group | Role | What they receive |
|---|---|---|
| Lubiprostone | Active comparator | Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days. Receives: Drug: lubiprostone; Other: Bowel preparation |
| Placebo | Placebo comparator | Subjects randomized to this arm received placebo medication for three days. Receives: Drug: Placebo; Other: Bowel preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic Compliance
Colonic compliance is a measure of the "stiffness" of the colon, that is, what pressure was needed to reach half the maximum volume of the colon.
After the barostat catheter was inserted in the colon, the catheter was connected to a barostat machine. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg up to 64 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance.
Measured: 1 hour after third dose of lubiprostone or placebo, on Day 3
Fasting Colonic Tone
Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon).
Measured: 30 minutes after the colonic tube placement, on Day 3
Postprandial Colonic Tone
Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon).
Measured: 30 minutes after standard meal, on Day 3
Pain Sensation Ratings in Response to Colonic Distension at 32 mm HG Above Baseline Operating Pressure
Pain was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.
Measured: approximately 1 hour after colonic tube placement, on Day 3
Secondary outcomes (4)
Gas Sensation Ratings in Response to Colonic Distensions at 32 mm Hg Above Baseline Operating Pressure
Gas sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no gas sensation and 100 mm for extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of gas sensation.
Measured: approximately 1 hour after colonic tube placement, on Day 3
Median Pressure When First Sensation Was Reported by 50% of Participants
The sensory threshold for first sensation was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mmg Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation.
Measured: approximately 45 min after colonic tube placement, on Day 3
Median Pressure When Gas Sensation Was First Reported by 50% of Participants
The sensory threshold for first perception of gas was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mmg Hg. During this assessment participants were asked to report when they had the first perception of gas. The investigator recorded the threshold pressure at which the participants reported this sensation.
Measured: approximately 45 min after colonic tube placement, on Day 3
Median Pressure When Pain Sensation Was First Reported by 50% of Participants
The sensory threshold for first perception of pain was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mmg Hg. During this assessment participants were asked to report when they had the first perception of pain. The investigator recorded the threshold pressure at which the participants reported this sensation.
Measured: approximately 45 min after colonic tube placement, on Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startSep 2007
- Primary completionJul 2008
- Study completionJul 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR), Takeda
- Investigators
- Michael Camilleri, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953043
- Sponsor's protocol ID
- 07-001438
- Other IDs
- K24DK002638, R01DK054681, UL1RR024150
- Status last verified
- Feb 2012
- First submitted
- 4 Aug 2009
- Last updated
- 27 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sweetser S, Busciglio IA, Camilleri M, Bharucha AE, Szarka LA, Papathanasopoulos A, Burton DD, Eckert DJ, Zinsmeister AR. Effect of a chloride channel activator, lubiprostone, on colonic sensory and motor functions in healthy subjects. Am J Physiol Gastrointest Liver Physiol. 2009 Feb;296(2):G295-301. doi: 10.1152/ajpgi.90558.2008. Epub 2008 Nov 25.
PubMed 19033530
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lubiprostone, a Chloride Channel Activator, on Colonic Sensorimotor Functions in Healthy Subjects. A Phase IV, Placebo-Controlled, Parallel Group Study
- ClinicalTrials.gov ID
- NCT00953043
- Acronym / sponsor ID
- 07-001438
- Conditions
- Healthy
- Keywords
- lubiprostone, colon, motility, sensation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR), Takeda
- Study start
- Sep 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Posted 9 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to evaluate the effects of lubiprostone, a drug approved and used for constipation, on pattern of contractions of the colon and the colon's sensitivity to distension.
Detailed description
This was a trial of healthy adults to compare the effects of oral lubiprostone, 24 microgram per day and placebo for three days, on sensation and contractions of the colon using validated methods.
On days 1 and 2, participants took the study medication with their breakfast and recorded the time. On day 2 starting at 4:00 pm, participants started a polyethylene glycol-based bowel preparation to cleanse the colon. After overnight bowl preparation, participants reported fasting to the study center at 7:00 am on day 3. Colonic sensorimotor functions were assessed by an endoscopically placed barostat-manometric assembly.
After 30 minutes of rest following tube placement, fasting colonic tone, colonic compliance and colonic sensation were tested. The last dose of medication was ingested and 1 hour later the same colonic functions, as well as colonic response to a standardized meal of a 1,000-kilocalorie chocolate milkshake were assessed. The participant was able to leave the study center in the afternoon, after a meal had been ingested (if desired).
Details on colonic tube placement: A flexible sigmoidoscopy was performed to evaluate the left side of the colon and to place a Teflon-coated guide wire beyond the splenic flexure. The colon was deflated as the sigmoidoscope was removed and a barostat catheter (constructed at Mayo Clinic, Rochester, MN) with six manometric point sensors and a polyethylene balloon was introduced into the colon over the guide wire. The barostat catheter was positioned in the mid-descending or upper sigmoid colon with the aid of fluoroscopy. The final position of the barostatically controlled balloon was confirmed by fluoroscopy. After the colonic tube placement, participants rested for 30 min. The catheter was connected to a rigid piston barostat machine. After transient inflation of the barostat bag to a volume of 75 ml to ensure it was unfolded, it was deflated. Thereafter, it was inflated in 2 mm Hg increments to baseline operating pressure, which was defined as 2 mm Hg above the minimal distension pressure at which respiratory excursions were clearly recorded by the barostat tracing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lubiprostone | Active comparator | Drug: lubiprostone, Other: Bowel preparationSubjects randomized to this arm received 24 micrograms of lubiprostone per day for three days. |
| Placebo | Placebo comparator | Drug: Placebo, Other: Bowel preparationSubjects randomized to this arm received placebo medication for three days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy subjects
- Body mass index (BMI): 18 to 32.
- Negative pregnancy test for women of childbearing potential.
- Absence of gastrointestinal symptoms (abridged Bowel Disease Questionnaire).
- Signed informed consent.
Key exclusion criteria (12 listed)
- Subjects with body mass index (BMI) of less than 18 or more than 32.
- Structural or metabolic diseases/conditions that affect the gastrointestinal (GI)system, or functional gastrointestinal disorders. For screening, the Bowel Disease Questionnaire will be used to exclude subjects with irritable bowel syndrome.
- Use of drugs or agents within the past 2 weeks that alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer antidepressants.
- NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection, and birth control pills or depot injections are permissible.
- Use of drugs or agents within the 2 weeks prior to screening that may add drowsiness and central nervous system (CNS) depression such as barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, antihistamines, muscle relaxants, other CNS depressants.
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: AmitizaLubiprostone 24 micrograms, one dose daily for three days in 30 subjects | Drug | Lubiprostone |
| PlaceboPlacebo medication given for three days | Drug | Placebo |
| Bowel preparationAlso: NuLytelyPolyethylene glycol-based bowel preparation | Other | Lubiprostone, Placebo |
Primary outcome
Colonic Compliance
Time frame: 1 hour after third dose of lubiprostone or placebo, on Day 3
Colonic compliance is a measure of the "stiffness" of the colon, that is, what pressure was needed to reach half the maximum volume of the colon. After the barostat catheter was inserted in the colon, the catheter was connected to a barostat machine. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg up to 64 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance.
Fasting Colonic Tone
Time frame: 30 minutes after the colonic tube placement, on Day 3
Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon).
Postprandial Colonic Tone
Time frame: 30 minutes after standard meal, on Day 3
Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon).
Pain Sensation Ratings in Response to Colonic Distension at 32 mm HG Above Baseline Operating Pressure
Time frame: approximately 1 hour after colonic tube placement, on Day 3
Pain was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.
4 secondary outcomes
Gas Sensation Ratings in Response to Colonic Distensions at 32 mm Hg Above Baseline Operating Pressure
Time frame: approximately 1 hour after colonic tube placement, on Day 3
Median Pressure When First Sensation Was Reported by 50% of Participants
Time frame: approximately 45 min after colonic tube placement, on Day 3
Median Pressure When Gas Sensation Was First Reported by 50% of Participants
Time frame: approximately 45 min after colonic tube placement, on Day 3
Median Pressure When Pain Sensation Was First Reported by 50% of Participants
Time frame: approximately 45 min after colonic tube placement, on Day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19033530Sweetser S, Busciglio IA, Camilleri M, Bharucha AE, Szarka LA, Papathanasopoulos A, Burton DD, Eckert DJ, Zinsmeister AR. Effect of a chloride channel activator, lubiprostone, on colonic sensory and motor functions in healthy subjects. Am J Physiol Gastrointest Liver Physiol. 2009 Feb;296(2):G295-301. doi: 10.1152/ajpgi.90558.2008. Epub 2008 Nov 25.
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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.
Michael Camilleri, MD principal investigator
Mayo Clinic
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 and Bowel preparation in people with Healthy, run by Mayo Clinic 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 5 inclusion and 12 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 27 Feb 2012. 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 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 9 Feb 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?
Colonic Compliance (time frame: 1 hour after third dose of lubiprostone or placebo, on Day 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00953043, which also lists 1 linked publication.
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 27 Feb 2012.