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MD-1100

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

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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Frequently asked questions about MD-1100

What is MD-1100 used for?

MD-1100 is an investigational small molecule being developed by Ironwood Pharmaceuticals for the treatment of constipation and irritable bowel syndrome. It is currently in Phase 2 clinical development, with completed trials in patients with chronic constipation and constipation-predominant irritable bowel syndrome.

Who makes MD-1100?

MD-1100 is being developed by Ironwood Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IRWD. The company is conducting clinical trials of MD-1100 for gastrointestinal conditions.

What phase is MD-1100 in?

MD-1100 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one in patients with irritable bowel syndrome and one in patients with chronic constipation. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is MD-1100 in?

MD-1100 has been studied in two completed Phase 2 trials. NCT00258193 evaluated MD-1100 acetate on gastrointestinal transit in patients with irritable bowel syndrome, enrolling 36 participants. NCT00306748 evaluated MD-1100 acetate administered for 14 days in patients with chronic constipation, enrolling 40 participants.

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

Yes, MD-1100 acetate is the salt form of MD-1100. The clinical trials NCT00258193 and NCT00306748 both studied MD-1100 acetate, which is the active pharmaceutical ingredient in the investigational drug product.