Ph2a Study to Evaluate IW-3718 in Patients With Gastroesophageal Reflux Not Completely Responsive to Proton Pump Inhibitors
A Phase 2a Study to Evaluate the Effect of IW-3718 Administered Orally for 4 Weeks in Patients With GERD Not Completely Responsive to Proton Pump Inhibitors
1 other identifier
interventional
93
1 country
10
Brief Summary
This study is meant to assess the effect of IW-3718 as an added treatment to ongoing once-daily protocol pump inhibitor (PPI) treatment for patients who continue to experience symptoms of their gastroesophageal reflux disease (GERD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2014
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2013
CompletedFirst Posted
Study publicly available on registry
January 9, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedAugust 1, 2016
July 1, 2016
10 months
December 19, 2013
July 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Exploratory Endpoints - GERD Symptoms
Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period
Study Arms (2)
IW-3718
EXPERIMENTALTwice a day
Matching Placebo
PLACEBO COMPARATORTwice a day
Interventions
Eligibility Criteria
You may qualify if:
- Patient is between 18 and 65 years of age at the Screening Visit; females must not be pregnant or must not be breastfeeding;
- Patient has a confirmed diagnosis of gastroesophageal reflux disease, must be currently taking a proton pump inhibitor (PPI), and must be experiencing GERD symptoms as specified by the protocol.
You may not qualify if:
- Patient may not meet any of the excluded conditions specified in the protocol;
- Patient is experiencing alarm symptoms such as GI bleeding, anemia, vomiting, dysphagia, or unexpected weight loss;
- Patient has a clinically significant hypersensitivity or allergies to any of the active ingredients or excipients in the study medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Ironwood Investigational Site
North Little Rock, Arkansas, 72117, United States
Ironwood Investigational Site
Anaheim, California, 92801, United States
Ironwood Investigational Site
Monroe, Louisiana, 71201, United States
Ironwood Investigational Site
Chesterfield, Michigan, 48047, United States
Ironwood Investigational Site
Raleigh, North Carolina, 27612, United States
Ironwood Investigational Site
Cleveland, Ohio, 44109, United States
Ironwood Investigational Site
Chattanooga, Tennessee, 37421, United States
Ironwood Investigational Site
Nashville, Tennessee, 37212, United States
Ironwood Investigational Site
Logan, Utah, 84341, United States
Ironwood Investigational Site
South Ogden, Utah, 84405, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2013
First Posted
January 9, 2014
Study Start
February 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
August 1, 2016
Record last verified: 2016-07