CovidResearchTrials by Shray Alag


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Report for D004942: Esophagitis, Peptic NIH

(Synonyms: Esophagitis, P, Esophagitis, Pepti, Esophagitis, Peptic)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)


Name (Synonyms) Correlation
drug1369 IW-3718 Wiki 1.00
drug3408 placebo Wiki 0.38

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D005764 Gastroesophageal Reflux NIH 0.82

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002020 Gastroesophageal reflux HPO 0.82

There are 2 clinical trials

Clinical Trials


1 A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients With Gastroesophageal Reflux Disease While Receiving Proton Pump Inhibitors

The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard-dose proton pump inhibitors (PPIs).

NCT03561090 Gastroesophageal Reflux Disease (GERD) Drug: IW-3718 Drug: placebo
MeSH:Gastroesophageal Reflux Esophagitis, Peptic
HPO:Gastroesophageal reflux

Primary Outcomes

Measure: Proportion of Overall Heartburn Responders

Time: Week 8

Secondary Outcomes

Measure: Proportion of Overall Heartburn Responders Among Participants With a Baseline Weekly Heartburn Severity Score (WHSS) ≥ 3

Time: Week 8

Measure: Percent Change From Baseline to Week 8 in WHSS

Time: Baseline, Week 8

Measure: Percent Change From Baseline to Week 8 in Weekly Regurgitation Frequency Score (WRFS)

Time: Baseline, Week 8

Measure: Proportion of Heartburn-Free (Daily Heartburn Severity Score [DHSS]=0) Days During the 8-Week Treatment Period

Time: up to Week 8

Measure: Proportion of Overall Regurgitation Responders

Time: Week 8

Measure: Proportion of Days When Heartburn Did Not Occur (DHSS=0) or Was Very Mild (DHSS=1) During the 8-Week Treatment Period

Time: Week 8

Measure: Proportion of Days When Regurgitation Did Not Occur (Daily Regurgitation Frequency Scores [DRFS]=0) or Rarely Occurred (DRFS=1) During the 8-Week Treatment Period

Time: Week 8

Measure: Proportion of Regurgitation-Free (DRFS=0) Days During the 8-Week Treatment Period

Time: Week 8

Measure: Change From Baseline to Week 8 in Each Modified Reflux Symptom Questionnaire Electronic Diary (mRESQ) Item

Time: Baseline, Week 8

Measure: Proportion of Nights With Difficulty Falling Asleep Due to GERD During the 8-Week Treatment Period

Time: Week 8

Measure: Proportion of Days With Nighttime Awakening Due to GERD During the 8-Week Treatment Period

Time: Week 8

Measure: Number of Degree of Relief (of Heartburn/Regurgitation/Overall GERD Symptoms) Responders

Time: up to Week 8

Measure: Change From Baseline to Week 8 in Heartburn/Regurgitation/Overall GERD Symptoms Bothersomeness

Time: Baseline, Week 8

Measure: Proportion of Days With Rescue Medication Use During the 8-Week Treatment Period

Time: up to Week 8

2 A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients With Gastroesophageal Reflux Disease While Receiving Proton Pump Inhibitors

The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standarddose proton pump inhibitors (PPIs).

NCT03561883 Gastroesophageal Reflux Disease (GERD) Drug: IW-3718 Drug: placebo
MeSH:Gastroesophageal Reflux Esophagitis, Peptic
HPO:Gastroesophageal reflux

Primary Outcomes

Measure: Proportion of Overall Heartburn Responders

Time: Week 8

Secondary Outcomes

Measure: Proportion of Overall Heartburn Responders Among Participants With a Baseline Weekly Heartburn Severity Score (WHSS) ≥ 3

Time: Week 8

Measure: Percent Change From Baseline to Week 8 in WHSS

Time: Baseline, Week 8

Measure: Percent Change From Baseline to Week 8 in Weekly Regurgitation Frequency Score (WRFS)

Time: Baseline, Week 8

Measure: Proportion of Heartburn-Free (Daily Heartburn Severity Score [DHSS]=0) Days During the 8-Week Treatment Period

Time: up to Week 8

Measure: Proportion of Overall Regurgitation Responders

Time: up to Week 8

Measure: Proportion of Days When Heartburn Did Not Occur (DHSS=0) or Was Very Mild (DHSS=1) During the 8-Week Treatment Period

Time: Week 8

Measure: Proportion of Days When Regurgitation Did Not Occur (Daily Regurgitation Frequency Scores [DRFS]=0) or Rarely Occurred (DRFS=1) During the 8-Week Treatment Period

Time: Week 8

Measure: Proportion of Regurgitation-Free (DRFS=0) Days During the 8-Week Treatment Period

Time: Week 8

Measure: Change From Baseline to Week 8 in Each Modified Reflux Symptom Questionnaire Electronic Diary (mRESQ) Item

Time: Baseline, Week 8

Measure: Proportion of Nights With Difficulty Falling Asleep Due to GERD During the 8-Week Treatment Period

Time: Week 8

Measure: Proportion of Days With Nighttime Awakening Due to GERD During the 8-Week Treatment Period

Time: Week 8

Measure: Number of Degree of Relief (of Heartburn/Regurgitation/Overall GERD Symptoms) Responders

Time: up to Week 8

Measure: Change From Baseline to Week 8 in Heartburn/Regurgitation/Overall GERD Symptoms Bothersomeness

Time: Baseline, Week 8

Measure: Proportion of Days With Rescue Medication Use During the 8-Week Treatment Period

Time: up to Week 8


HPO Nodes