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MD-1100

Phase 2

Constipation | Small molecule | Gastrointestinal |Ironwood Pharmaceuticals, Inc.|Trials Updated: Mar 24, 2009

MD-1100 target and mechanism

ModalitySmall molecule

Also known as MD-1100 Acetate

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment76

FDA Designations

No designations recorded

MD-1100 clinical trials

MD-1100 · 2 trials · 2 indications

Phase 2 2
NCT00306748Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic ConstipationConstipation
COMPLETED40 Analytics
NCT00258193Phase 2 Study of MD-1100 Acetate on Gastrointestinal Transit in Patients With C-IBSIrritable Bowel Syndrome
COMPLETED36 Analytics
PHASE2COMPLETED
Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic Constipation
ConstipationUnlock trial analytics
PHASE2COMPLETED
Phase 2 Study of MD-1100 Acetate on Gastrointestinal Transit in Patients With C-IBS
Irritable Bowel SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety will be evaluated on an ongoing basis by completing physical examinations, ECGs, clinical laboratory tests, and adverse event reporting.
(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 Endpoints

Stool Frequency will be reported daily
Stool Consistency (Bristol Stool Form Scale) will be reported daily
Stool Ease of Passage will be reported daily
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
MD-1100 AcetateDRUG -
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * 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 fi...

Countries:United States
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Competitive Landscape -Constipation 3 trials

No competing companies are currently tracked in active development for Constipation.
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Frequently asked questions about MD-1100

What is MD-1100?

MD-1100 is an investigational small molecule developed by Ironwood Pharmaceuticals, Inc. (ticker IRWD) for gastrointestinal conditions. It has been studied in Phase 2 clinical trials for constipation and irritable bowel syndrome. MD-1100 is also known as MD-1100 Acetate.

What is MD-1100 used for?

MD-1100 has been studied for the treatment of constipation and irritable bowel syndrome. Specifically, clinical trials have evaluated it in patients with chronic constipation and in patients with constipation-predominant irritable bowel syndrome (C-IBS). It is an investigational therapy and has not been approved for any indication.

Who makes MD-1100?

MD-1100 is being developed by Ironwood Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker symbol IRWD. Ironwood is a gastrointestinal-focused biopharmaceutical company.

What phase is MD-1100 in?

MD-1100 is in Phase 2 clinical development. It has completed Phase 2 trials for constipation and irritable bowel syndrome. No Phase 3 trials have been reported, and the drug remains investigational.

What clinical trials is MD-1100 in?

MD-1100 has been evaluated in two completed Phase 2 trials: NCT00306748, which studied MD-1100 Acetate administered for 14 days in 40 patients with chronic constipation, and NCT00258193, which studied MD-1100 Acetate's effect on gastrointestinal transit in 36 patients with constipation-predominant irritable bowel syndrome. Both trials were conducted in the United States.

Is MD-1100 the same as MD-1100 Acetate?

Yes, MD-1100 Acetate is an alternative name for MD-1100. The two names refer to the same investigational drug candidate. Clinical trial records for MD-1100 use the acetate form designation.