NCT02637557
Completed
Phase 2
A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-range-finding Trial of IW-3718 Administered Orally for 8 Weeks to Patients With Symptomatic Gastroesophageal Reflux Disease Not Completely Responsive to Proton Pump Inhibitors
ConditionsGastroesophageal Reflux Disease
Overview
- Phase
- Phase 2
- Intervention
- Matching Placebo
- Conditions
- Gastroesophageal Reflux Disease
- Sponsor
- Ironwood Pharmaceuticals, Inc.
- Enrollment
- 282
- Locations
- 1
- Primary Endpoint
- Percent Change From Baseline to Week 8 in Weekly Heartburn Severity Score (WHSS)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is an ambulatory, community-dwelling male or nonpregnant female and is at least 18 years old at the Screening Visit. Lactating females must agree not to breastfeed.
- •Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or regurgitation) on ≥ 4 days per week during the 8 weeks before the Screening Visit while taking standard QD PPI therapy.
Exclusion Criteria
- •Patient may not meet any of the excluded conditions specified in the protocol
- •Patient has any alarm symptoms including but not limited to GI bleeding, anemia, vomiting, dysphagia, or unexpected weight loss any time during the Screening or Pretreatment Periods
- •Patient has a history of clinically significant hypersensitivity or allergies to any of the excipients contained in the study medication (active or placebo).
- •NOTE: Additional inclusion/exclusion criteria may apply.
Arms & Interventions
Control
Matching placebo twice daily
Intervention: Matching Placebo
Control
Matching placebo twice daily
Intervention: PPI
500 mg IW-3718
500 mg IW-3718 twice daily
Intervention: IW-3718
500 mg IW-3718
500 mg IW-3718 twice daily
Intervention: PPI
1000 mg IW-3718
1000 mg IW-3718 twice daily
Intervention: IW-3718
1000 mg IW-3718
1000 mg IW-3718 twice daily
Intervention: PPI
1500 mg IW-3718
1500 mg IW-3718 twice daily
Intervention: IW-3718
1500 mg IW-3718
1500 mg IW-3718 twice daily
Intervention: PPI
Outcomes
Primary Outcomes
Percent Change From Baseline to Week 8 in Weekly Heartburn Severity Score (WHSS)
Time Frame: Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8
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.
Secondary Outcomes
- Change From Baseline Over Time in the mRESQ-eD Item 'Hoarseness Severity'(Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8)
- Change From Baseline Over Time in the mRESQ-eD Item 'Cough Severity'(Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8)
- Percentage of Participants Who Are Overall Heartburn Responders(Week 8)
- Percent Change From Baseline to Week 4 in WHSS(Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4)
- Change From Baseline to Week 8 in WHSS(Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8)
- Change From Baseline to Week 4 in WHSS(Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4)
- Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 8(Week 8)
- Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 4(Week 4)
- Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 8(Week 8)
- Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 4(Week 4)
- Change From Baseline Over Time in the Weekly Average of Modified Reflux Symptom Questionnaire - Electronic Diary (mRESQ-eD) Item 'Heartburn Severity'(Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8)
- Change From Baseline Over Time in the Weekly Average of mRESQ-eD Item 'Burning Feeling Behind Breastbone or Center of Upper Stomach Severity'(Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8)
- Change From Baseline Over Time in the mRESQ-eD Item 'Pain Behind Breastbone or Center of Upper Stomach Severity'(Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8)
- Change From Baseline Over Time in the mRESQ-eD Item 'Difficulty Swallowing Severity'(Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8)
- Change From Baseline Over Time in the mRESQ-eD Item 'Regurgitation Frequency'(Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8)
- Change From Baseline Over Time in the mRESQ-eD Item 'Acid or Bitter Taste Frequency'(Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8)
- Change From Baseline Over Time in the mRESQ-eD Item 'Coughing Frequency'(Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8)
- Change From Baseline Over Time in the mRESQ-eD Item 'Burping Frequency'(Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8)
- Change From Baseline in the Proportion of Heartburn-Free Days During Week 8(Week 8)
- Change From Baseline in the Proportion of Heartburn-Free Days During Week 4(Week 4)
Study Sites (1)
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