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Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03561883
Recruitment Status : Active, not recruiting
First Posted : June 19, 2018
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease (GERD) Drug: IW-3718 Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 6, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD Heartburn

Arm Intervention/treatment
Experimental: 1500 mg IW-3718 BID
Three 500 mg IW-3718 tablets administered twice daily (BID), immediately after the morning and evening meals.
Drug: IW-3718
oral tablet

Placebo Comparator: Placebo
Three placebo tablets administered BID immediately after the morning and evening meals.
Drug: placebo
oral tablet




Primary Outcome Measures :
  1. Change From Baseline at Week 8 in Weekly Heartburn Severity Score (WHSS) [ Time Frame: Baseline, Week 8 ]
    The WHSS for a week is the average of the non-missing Daily Heartburn Severity Scores (DHSS) for that week. The DHSS for a day is the greater score of the 2 modified Reflux Symptom Questionnaire (mRESQ) items assessing heartburn severity ("Burning feeling behind the breastbone or in the center of the upper stomach" and "Pain behind the breastbone or in the center of the upper stomach") for that day.


Secondary Outcome Measures :
  1. Change From Baseline at Week 8 in Weekly Regurgitation Frequency Score (WRFS) [ Time Frame: Baseline, Week 8 ]
    The WRFS for a week is the average of the non-missing Daily Regurgitation Frequency Scores (DRFS) for that week. DRFS for a day is the greater score of the 2 mRESQ items assessing regurgitation frequency ("Regurgitation [liquid or food moving upwards toward your throat or mouth]" and "An acid or bitter taste in the mouth") for that day.

  2. Proportion of Overall Heartburn Responders During the 8-Week Treatment Period [ Time Frame: Up to Week 8 ]
    An overall heartburn responder is defined as a participant who is a weekly heartburn responder for at least 4 weeks, including at least 1 of the last 2 weeks (Weeks 7 and 8), during the 8-week Treatment Period. A weekly heartburn responder is a participant with a decrease from baseline of ≥ 45% in Weekly Heartburn Severity Score (WHSS).

  3. Proportion of Heartburn-Free Days During the 8-Week Treatment Period [ Time Frame: Up to Week 8 ]
    Proportion of heartburn-free days is calculated as the number of heartburn-free (DHSS=0) days divided by the number of diary entry days.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Each patient must meet all of the following criteria to be eligible for enrollment in this study:

  • Patient is an ambulatory male or female (if female, nonpregnant) and is at least 18 years old at the Screening Visit.
  • Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or regurgitation) while taking standard proton pump inhibitor (PPI) therapy.
  • Patient has evidence of pathological acid reflux.
  • Female patients must not be pregnant and must agree to avoid pregnancy for the duration of the study.
  • Patient must comply with study procedures.

Exclusion Criteria:

Patients who meet any of the following criteria will not be eligible to participate in the study:

  • Patient has a history of complete lack of GERD symptom response to PPI therapy.
  • Patient has a significant medical or surgical history including conditions that would impact drug absorption or metabolism (such as bowel obstruction, poorly controlled diabetes, gastroparesis, hiatal hernia).
  • Patient reports pain or burning behind the breastbone or in the center of the upper stomach as his or her predominant symptom at the Screening Visit.
  • Patient has received an investigational drug during the 30 days before the Screening Visit, or is planning to receive another investigational drug or use an investigational device at any time during the study.

NOTE: Other inclusion and exclusion criteria apply, per the study protocol.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561883


Locations
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Sponsors and Collaborators
Ironwood Pharmaceuticals, Inc.
Investigators
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Study Chair: Zurab Machaidze, MD Ironwood Pharmaceuticals, Inc.
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Responsible Party: Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03561883    
Other Study ID Numbers: C3718-302
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ironwood Pharmaceuticals, Inc.:
Gastroesophageal Reflux Disease
GERD
Proton Pump Inhibitor
IW-3718
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases