Back to resultsPh2a Study to Evaluate IW-3718 in Patients With Gastroesophageal Reflux Not Completely Responsive to Proton Pump Inhibitors
Primary Purpose
Gastroesophageal Reflux
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IW-3718
Matching Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Ironwood Investigational Site
- Ironwood Investigational Site
- Ironwood Investigational Site
- Ironwood Investigational Site
- Ironwood Investigational Site
- Ironwood Investigational Site
- Ironwood Investigational Site
- Ironwood Investigational Site
- Ironwood Investigational Site
- Ironwood Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
IW-3718
Matching Placebo
Arm Description
Twice a day
Twice a day
Outcomes
Primary Outcome Measures
Exploratory Endpoints - GERD Symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT02030925
First Posted
December 19, 2013
Last Updated
July 28, 2016
Sponsor
Ironwood Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02030925
Brief Title
Ph2a Study to Evaluate IW-3718 in Patients With Gastroesophageal Reflux Not Completely Responsive to Proton Pump Inhibitors
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ironwood Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IW-3718
Arm Type
Experimental
Arm Description
Twice a day
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Arm Description
Twice a day
Intervention Type
Drug
Intervention Name(s)
IW-3718
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Primary Outcome Measure Information:
Title
Exploratory Endpoints - GERD Symptoms
Time Frame
Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Ironwood Investigational Site
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Ironwood Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Ironwood Investigational Site
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Ironwood Investigational Site
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Ironwood Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Ironwood Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Ironwood Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Ironwood Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Ironwood Investigational Site
City
Logan
State/Province
Utah
ZIP/Postal Code
84341
Country
United States
Facility Name
Ironwood Investigational Site
City
South Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ph2a Study to Evaluate IW-3718 in Patients With Gastroesophageal Reflux Not Completely Responsive to Proton Pump Inhibitors
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