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MD-1100

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00306748Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic ConstipationPHASE2 COMPLETED 40 — — Mar 1, 2006Aug 1, 2006Mar 24, 200914 United States
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Study Endpoints
Primary Endpoints
Safety will be evaluated on an ongoing basis by completing physical examinations, ECGs, clinical laboratory tests, and adverse event reporting.
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 — 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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