Irritable Bowel SyndromePhase 2NCT00258193
Phase 2 Study of MD-1100 Acetate on Gastrointestinal Transit in Patients With C-IBS
A Phase 2 study testing MD-1100 Acetate in people with Irritable Bowel Syndrome, run by Ironwood Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The primary objective of this trial is to compare the dose-ranging pharmacodynamic effects of orally administered placebo, and 100 and 1000 ug qd of MD-1100 Acetate on gastrointestinal transit in patients with C-IBS. The secondary objectives of this trial are: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- MD-1100 Acetate
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Sep 2006
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient agrees to use a medically accepted, double-barrier form of contraception (e.g., IUD and condom) during participation;
- No evidence of pelvic floor dysfunction and the completion of a negative digital rectal exam prior to the first dose of study medication;
- Absence of an evacuation disorder as defined per protocol;
- Patients must meet ROME II Criteria for C-IBS;
- The patient's Baseline Colonic Transit Test must show a geometric center (GC) ≤ 2.65 at 24 hours, or ≤ 3.0 at 24 hours and ≤ 3.9 at 48 hours.
Who cannot join
- History of clinically-significant manifestations of any major system organ class;
- History of inflammatory bowel disease or gastric ulcers;
- Significant GI surgery within 6 months;
- Clinically-significant prolonged diarrhea within 60 days;
- Special dietary habit and/or an intense physical workout program within 4 weeks;
- Certain drug hypersensitivities
Show all 9Show fewer
- History of alcoholism or drug addiction within 12 months;
- Receipt of an investigational drug during the study or within 30 days;
- Use of any prescription medication or OTC, non-prescription medications disallowed by the protocol within 7 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study of the Pharmacodynamic Effects of Orally Administered 100ug and 1000ug QD MD-1100 Acetate on Gastrointestinal Transit in Patients With Constipation Predominant Irritable Bowel Syndrome (C-IBS)
- The primary objective of this trial is to compare the dose-ranging pharmacodynamic effects of orally administered placebo, and 100 and 1000 ug qd of MD-1100 Acetate on gastrointestinal transit in patients with C-IBS.
- The secondary objectives of this trial are:
- To compare the dose ranging pharmacodynamic effects of placebo, and 100 and 1000 ug MD-1100 Acetate once daily on time to first bowel movement after first drug intake.
- To describe and summarize the effects of placebo, and 100 and 1000 ug MD-1100 Acetate once daily on stool frequency, stool consistency, ease of passage and sensation of incomplete evacuation during the Treatment Period relative to Baseline.
Read the detailed description
Using a double-blind, randomized, placebo-controlled, parallel group study design, the effects of placebo and two different doses of orally administered MD-1100 Acetate on gastric emptying, small bowel transit and total colonic transit will be compared and evaluated in patients with C-IBS.
After eligibility is confirmed, the patient will return for baseline measurement of colonic transit to ensure that the transit profile is not greater than the mean transit profile of healthy controls in order to avoid a ceiling effect. A patient must have a geometric center of ≤2.65 at 24 hours, or ≤3.0 at 24 hours and ≤3.9 at 48 hours in order to be randomized to a 5-day Treatment Period of study medication. Eligible patients will receive oral study medication for 5 days during which colonic transit will be measured.
Approximately 36 (n=36) patients will be randomized to one of three different treatment groups: placebo (n=12), 100 ug MD-1100 (n=12), or 1000 ug MD-1100 (n=12). All dosing of study medication will be supervised at the Mayo Clinic.
Patients will complete a daily Stool Diary to record bowel habits for 5 consecutive days during the Pretreatment Period and then for the 5 consecutive days of the Treatment PeriodPhysical examinations, vital signs, electrocardiograms, and clinical laboratory tests will be performed throughout the study and adverse events will be recorded for safety evaluation.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- MD-1100 Acetate
- Keywords
- C-IBS, IBS-C, Constipation-predominant Irritable Bowel Syndrome, Constipation Predominant Irritable Bowel Syndrome, Irritable Bowel Syndrome, IBS, Transit, Scintigraphy, Gastroenterology, Gastrointestinal, GC, MD-1100 Acetate, MD-1100, linaclotide, linaclotide acetate
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MD-1100 AcetateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
(Safety) AEs to be collected beginning with patient's first administration of study medication through final study visit
Clinical chemistry, hematology, and urinalyses to be performed before and after the Treatment Period
Cardiac safety will be monitored by ECG recordings
(Efficacy) Primary endpoints for analysis of efficacy are the colonic geometric center (GC) at 24 hours and ascending colon t1/2 values.
Secondary outcomes (1)
Secondary transit endpoints will be gastric emptying t1/2, colonic filling at 6 hours, colonic GC at additional time points including 48 hours, and time to first bowel movement after the first dose of medication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2005 (estimated)
- Study startJan 2006
- Study completionSep 2006
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Camilleri, MD, Principal investigator, Mayo Clinic Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258193
- Sponsor's protocol ID
- Protocol MCP-103-005
- Status last verified
- Oct 2006
- First submitted
- 22 Nov 2005
- Last updated
- 20 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study of the Pharmacodynamic Effects of Orally Administered 100ug and 1000ug QD MD-1100 Acetate on Gastrointestinal Transit in Patients With Constipation Predominant Irritable Bowel Syndrome (C-IBS)
- ClinicalTrials.gov ID
- NCT00258193
- Acronym / sponsor ID
- Protocol MCP-103-005
- Conditions
- Irritable Bowel Syndrome
- Keywords
- C-IBS, IBS-C, Constipation-predominant Irritable Bowel Syndrome, Constipation Predominant Irritable Bowel Syndrome, Irritable Bowel Syndrome, IBS, Transit, Scintigraphy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- Study completion
- Sep 2006
- First posted
- 24 Nov 2005 (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 primary objective of this trial is to compare the dose-ranging pharmacodynamic effects of orally administered placebo, and 100 and 1000 ug qd of MD-1100 Acetate on gastrointestinal transit in patients with C-IBS.
- The secondary objectives of this trial are:
- To compare the dose ranging pharmacodynamic effects of placebo, and 100 and 1000 ug MD-1100 Acetate once daily on time to first bowel movement after first drug intake.
- To describe and summarize the effects of placebo, and 100 and 1000 ug MD-1100 Acetate once daily on stool frequency, stool consistency, ease of passage and sensation of incomplete evacuation during the Treatment Period relative to Baseline.
Detailed description
Using a double-blind, randomized, placebo-controlled, parallel group study design, the effects of placebo and two different doses of orally administered MD-1100 Acetate on gastric emptying, small bowel transit and total colonic transit will be compared and evaluated in patients with C-IBS.
After eligibility is confirmed, the patient will return for baseline measurement of colonic transit to ensure that the transit profile is not greater than the mean transit profile of healthy controls in order to avoid a ceiling effect. A patient must have a geometric center of ≤2.65 at 24 hours, or ≤3.0 at 24 hours and ≤3.9 at 48 hours in order to be randomized to a 5-day Treatment Period of study medication. Eligible patients will receive oral study medication for 5 days during which colonic transit will be measured.
Approximately 36 (n=36) patients will be randomized to one of three different treatment groups: placebo (n=12), 100 ug MD-1100 (n=12), or 1000 ug MD-1100 (n=12). All dosing of study medication will be supervised at the Mayo Clinic.
Patients will complete a daily Stool Diary to record bowel habits for 5 consecutive days during the Pretreatment Period and then for the 5 consecutive days of the Treatment PeriodPhysical examinations, vital signs, electrocardiograms, and clinical laboratory tests will be performed throughout the study and adverse events will be recorded for safety evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient agrees to use a medically accepted, double-barrier form of contraception (e.g., IUD and condom) during participation;
- No evidence of pelvic floor dysfunction and the completion of a negative digital rectal exam prior to the first dose of study medication;
- Absence of an evacuation disorder as defined per protocol;
- Patients must meet ROME II Criteria for C-IBS;
- The patient's Baseline Colonic Transit Test must show a geometric center (GC) ≤ 2.65 at 24 hours, or ≤ 3.0 at 24 hours and ≤ 3.9 at 48 hours.
Key exclusion criteria (9 listed)
- History of clinically-significant manifestations of any major system organ class;
- History of inflammatory bowel disease or gastric ulcers;
- Significant GI surgery within 6 months;
- Clinically-significant prolonged diarrhea within 60 days;
- Special dietary habit and/or an intense physical workout program within 4 weeks;
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 |
|---|---|---|
| MD-1100 Acetate | Drug | – |
Primary outcome
(Safety) AEs to be collected beginning with patient's first administration of study medication through final study visit
Clinical chemistry, hematology, and urinalyses to be performed before and after the Treatment Period
Cardiac safety will be monitored by ECG recordings
(Efficacy) Primary endpoints for analysis of efficacy are the colonic geometric center (GC) at 24 hours and ascending colon t1/2 values.
1 secondary outcome
Secondary transit endpoints will be gastric emptying t1/2, colonic filling at 6 hours, colonic GC at additional time points including 48 hours, and time to first bowel movement after the first dose of medication.
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 20 Oct 2006.
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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 Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MD-1100 Acetate in people with Irritable Bowel Syndrome, run by Ironwood Pharmaceuticals, Inc. 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 9 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 20 Oct 2006. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
(Safety) AEs to be collected beginning with patient's first administration of study medication through final study visit. 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?
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 20 Oct 2006.