Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02637557 · ClinicalTrials.gov registry record · Phase 2
A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)
A Phase 2 study of Gastroesophageal Reflux Disease, sponsored by Ironwood Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 282
- Enrollment target
- 20
- Study locations
NCT02637557: Completed Phase 2 study of Gastroesophageal Reflux Disease, sponsored by Ironwood Pharmaceuticals.
NCT02637557 is a Phase 2 study of Gastroesophageal Reflux Disease that has completed, run by Ironwood Pharmaceuticals. The registered enrollment target is 282 participants, below the 345-participant average among 25 other Gastroesophageal Reflux Disease trials with a reported enrollment target (18% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02637557, a Phase 2 study of Gastroesophageal Reflux Disease, has completed, sponsored by Ironwood Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 282 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objectives of this study are to evaluate the safety, efficacy, and dose-response relationship of IW-3718 administered orally to participants who have GERD and continue to experience GERD symptoms while receiving once-daily (QD), standard-dose proton pump inhibitors (PPIs).
Primary Outcome
The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. A negative change from Baseline indicates improvement.
Conditions Studied
Interventions
- DRUG Matching Placebo
- DRUG IW-3718
- DRUG PPI
Study Locations (20)
California
- IW-3718 Investigator - Anaheim
- IW-3718 Investigator - Carmichael
- IW-3718 Investigator - Chula Vista
- IW-3718 Investigator - La Mirada
- IW-3718 Investigator - Mission Hills
- IW-3718 Investigator - Newport Beach
- IW-3718 Investigator - Oakland
- IW-3718 Investigator - Sacramento
- IW-3718 Investigator - San Diego
Arizona
- IW-3718 Investigator - Phoenix
- IW-3718 Investigator - Tucson
- IW-3718 Investigator - Tucson
- IW-3718 Investigator - Tucson
Florida
- IW-3718 Investigator - DeLand
- IW-3718 Investigator - Hollywood
- IW-3718 Investigator - Inverness
Connecticut
- IW-3718 Investigator - Bristol
- IW-3718 Investigator - Waterbury
Alabama
- IW-3718 Investigator - Dothan
Arkansas
- IW-3718 Investigator - North Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 282 participants |
| Start Date | 2016-03-01 |
| Est. Completion | 2017-04-26 |
| Phase | Phase 2 |
What the finished NCT02637557 record still lists
NCT02637557 is an interventional study that assigns participants to a tested intervention. The registered 282 participants enrollment target is mid-sized for trials with a published cap, below the 345-participant average among 25 other Gastroesophageal Reflux Disease trials with a reported enrollment target (18% lower).
The record links to 1 condition, with Gastroesophageal Reflux Disease appearing as the primary indexed condition, and to 3 interventions - of which Matching Placebo is the first listed.
NCT02637557 names 20 study sites across 6 states, led by California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT02637557 about?
NCT02637557 is a clinical study titled "A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)". The objectives of this study are to evaluate the safety, efficacy, and dose-response relationship of IW-3718 administered orally to participants who have GERD and continue to experience GERD symptoms while receiving once-daily (QD), standard-dose proton pump inhibitors (PPIs).
What is the current status of trial NCT02637557?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 282 participants. The study started on 2016-03-01. Estimated completion is 2017-04-26.
What conditions does trial NCT02637557 study?
This clinical trial studies the following conditions: Gastroesophageal Reflux Disease.
What interventions are being tested in trial NCT02637557?
The interventions under investigation include: Matching Placebo (DRUG), IW-3718 (DRUG), PPI (DRUG).
Who is sponsoring clinical trial NCT02637557?
This trial is sponsored by Ironwood Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02637557 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gastroesophageal Reflux Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02637557's enrollment target sits among peer trials
282 6th of 25 higher than 20 of 25 other Gastroesophageal Reflux Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroesophageal Reflux Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents
COMPLETED · Phase 2
-
Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)
COMPLETED · Phase 2
-
Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules in Treating Symptomatic Non-Erosive Gastroesophageal Reflux Disease in Adolescents
COMPLETED · Phase 2
-
The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis
COMPLETED · Phase 2
-
Maintenance Intermittent Therapy for Symptomatic GERD Patients
COMPLETED · Phase 2
-
Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients With Rabeprazole
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02860364 · 282 participants · NA
Comparing Hypothermic Temperatures During Hemiarch Surgery
- NCT04867395 · 282 participants · NA
A Multi-Phase Study Examining Hospital to Home Transitions for Children With Medical Complexity
- NCT05101070 · 282 participants · Phase 1
S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors
- NCT06276491 · 282 participants · Phase 1
Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI