Covid 19 Research using Clinical Trials (Home Page)
Report for D005764: Gastroesophageal Reflux NIH
(Synonyms: Gastroesophageal Refl, Gastroesophageal Reflux)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (5)
Correlated MeSH Terms (3)
There are 3 clinical trials
Clinical Trials
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
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
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
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
The aim of this study is to evaluate patient and consultant experiences with phone
consultations for endoscopy-related outpatient appointments during the COVID-19 outbreak.