ConstipationPhase 2NCT00306748
Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic Constipation
A Phase 2 study testing MD-1100 Acetate in people with Constipation, run by Ironwood Pharmaceuticals, Inc. at 14 sites in United States.
Trial summary
The purpose of this study is to determine the safety and gastrointestinal pharmacodynamics (stool frequency, stool consistency, stool ease of passage, stool completeness of evacuation) of MD-1100 acetate administered daily for 14 days. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Constipation
- What is being tested?
- MD-1100 Acetate
- How many people
- 40 participants
- Where
- 14 sitesUnited States
- Study dates
- Mar 2006to Aug 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant, non-breastfeeding female, age 18-70 years old at the time of first dose;
- Sexually active patients of childbearing potential agree to use double-barrier birth control;
- Females of childbearing potential must complete negative pregnancy tests prior to first dose;
- Negative colonoscopy within 10 years or completion of negative flexible sigmoidoscopy if under the age of 50 provided there is no history of rectal bleeding, weight loss, or anemia;
- BMI must be greater than/equal to 18.5 and less than 35.0;
- Successful completion of physical exam, 12-lead ECG, clinical laboratory tests prior to first dose of study medication;
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- Vital signs must not have clinically-significant findings within 4 hours of first dose of study medication;
- Patient reports 3 or less spontaneous bowel movements (SBMs) per week and meets 1 or more of the following criteria for constipation for 12 weeks in the previous 12 months: straining at least 25% bowel movements (BMs), lumpy or hard stools at least 25% of BMs, or sensation of incomplete evacuation at least 25% of BMs;
- Patient reports 3 or less SBMs during the 7-day Pre-treatment Period;
- Patient is compliant with IVRS for at least 6 days in the 7-day Pre-treatment Period.
Who cannot join
- Use of investigational drug within 30 days;
- Laxative/enema-induced diarrhea within 60 days;
- Patient meets ROME II criteria for functional diarrhea;
- Most bothersome symptom is moderate or severe abdominal pain or abdominal discomfort;
- History of cancer, inflammatory bowel disease, ischemic colitis, bowel resection, colostomy, or fecal impaction;
- Diagnosis of cathartic colon or laxative/enema abuse, pelvic floor dysfunction, evacuation disorder, bulimia, anorexia, or neurological disorders;
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- Surgery within 30 days or GI surgery within 6 months of first dose of study medication. Cholecystectomy and/or appendectomy are acceptable if completed more than 60 days prior to first dose of study medication;
- Patient may not use any disallowed medications (prescription and/or over-the-counter treatments for chronic constipation or C-IBS, drugs that target 5-HT4, 5-HT2b, or 5-HT3 receptors, narcotics, anti-cholinergic agents, GI preparations, etc.) during the 7-day Pre-treatment Period or during the study. Stable, continuous (30 days or more) use of dietary fiber is acceptable.
- Any acute or chronic condition that would limit the patient's ability to complete and/or participate in the study.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Austin Gastroenterology, P.A.
Austin, Texas, 78745
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Consultants for Clinical Research of South Florida
Boynton Beach, Florida, 33426
UC for Functional GI & Motility Disorders
Chapel Hill, North Carolina, 27599-7080
ClinSearch
Chattanooga, Tennessee, 37304
Trinity Clinic - Corsicana
Corsicana, Texas, 75110
Memphis Gastroenterology Clinic
Germantown, Tennessee, 38120
Vital Research
Greensboro, North Carolina, 27408
Clinical Research Associates
Huntsville, Alabama, 35801
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112
Vantage Clinical Research
Olympia, Washington, 98506
Chung H. Kim, MD
Pittsford, New York, 14534
East Coast Clinical Research, LLC
Virginia Beach, Virginia, 23454
About this study
Official title: A Randomized, Multicenter, Double-Blind, Parallel-Design, Phase 2 Trial of Oral MD-1100 Acetate Administered for 14 Days Once Daily at 100 ug, 300 ug, 1000 ug, or Placebo to Patients With Chronic Constipation
The purpose of this study is to determine the safety and gastrointestinal pharmacodynamics (stool frequency, stool consistency, stool ease of passage, stool completeness of evacuation) of MD-1100 acetate administered daily for 14 days.
- Conditions
- Constipation
- Being tested
- MD-1100 Acetate
- Keywords
- Chronic Constipation, Chronic Idiopathic Constipation, Constipation, CIC, CC, MD-1100, MD-1100 Acetate, Microbia, Microbia, Inc., linaclotide, linaclotide acetate
- Medical subject headings
- Constipation
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 will be evaluated on an ongoing basis by completing physical examinations, ECGs, clinical laboratory tests, and adverse event reporting.
Secondary outcomes (8)
Stool Frequency will be reported daily
Stool Consistency (Bristol Stool Form Scale) will be reported daily
Stool Ease of Passage will be reported daily
Stool Completeness of Evacuation will be reported daily
Patient Assessment of Abdominal Discomfort will be reported weekly
Patient Assessment of Constipation will be reported weekly
Patient Assessment of Overall Relief will be reported weekly
Part 1 of the Irritable Bowel Symptom Severity Scale (IBSSS) will be reported once pre-dose and once post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2006 (estimated)
- Study startMar 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies 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
- 40 participants
Sponsor and investigators
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jeffrey M. Johnston, MD, FACP, Study director, Microbia, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306748
- Sponsor's protocol ID
- MCP-103-004
- Status last verified
- Mar 2009
- First submitted
- 20 Mar 2006
- Last updated
- 24 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-Blind, Parallel-Design, Phase 2 Trial of Oral MD-1100 Acetate Administered for 14 Days Once Daily at 100 ug, 300 ug, 1000 ug, or Placebo to Patients With Chronic Constipation
- ClinicalTrials.gov ID
- NCT00306748
- Acronym / sponsor ID
- MCP-103-004
- Conditions
- Constipation
- Keywords
- Chronic Constipation, Chronic Idiopathic Constipation, Constipation, CIC, CC, MD-1100, MD-1100 Acetate, Microbia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2006
- Study completion
- Aug 2006
- First posted
- 24 Mar 2006 (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 study is to determine the safety and gastrointestinal pharmacodynamics (stool frequency, stool consistency, stool ease of passage, stool completeness of evacuation) of MD-1100 acetate administered daily for 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or non-pregnant, non-breastfeeding female, age 18-70 years old at the time of first dose;
- Sexually active patients of childbearing potential agree to use double-barrier birth control;
- Females of childbearing potential must complete negative pregnancy tests prior to first dose;
- Negative colonoscopy within 10 years or completion of negative flexible sigmoidoscopy if under the age of 50 provided there is no history of rectal bleeding, weight loss, or anemia;
- BMI must be greater than/equal to 18.5 and less than 35.0;
Key exclusion criteria (9 listed)
- Use of investigational drug within 30 days;
- Laxative/enema-induced diarrhea within 60 days;
- Patient meets ROME II criteria for functional diarrhea;
- Most bothersome symptom is moderate or severe abdominal pain or abdominal discomfort;
- History of cancer, inflammatory bowel disease, ischemic colitis, bowel resection, colostomy, or fecal impaction;
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 will be evaluated on an ongoing basis by completing physical examinations, ECGs, clinical laboratory tests, and adverse event reporting.
8 secondary outcomes
Stool Frequency will be reported daily
Stool Consistency (Bristol Stool Form Scale) will be reported daily
Stool Ease of Passage will be reported daily
Stool Completeness of Evacuation will be reported daily
Patient Assessment of Abdominal Discomfort will be reported weekly
Patient Assessment of Constipation will be reported weekly
Patient Assessment of Overall Relief will be reported weekly
Part 1 of the Irritable Bowel Symptom Severity Scale (IBSSS) will be reported once pre-dose and once post-dose.
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 24 Mar 2009.
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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.
Jeffrey M. Johnston, MD, FACP study director
Microbia, Inc.
14 sites 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 Constipation, run by Ironwood Pharmaceuticals, Inc. at 14 sites 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 10 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 24 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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 will be evaluated on an ongoing basis by completing physical examinations, ECGs, clinical laboratory tests, and adverse event reporting.. 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 24 Mar 2009.