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

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ClinicalTrials.gov Identifier: NCT03561883
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE June 7, 2018
First Posted Date  ICMJE June 19, 2018
Last Update Posted Date January 10, 2019
Actual Study Start Date  ICMJE September 6, 2018
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2018)
Proportion of Overall Heartburn Responders [ Time Frame: Week 8 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
Number of Overall Heartburn Responders [ Time Frame: Week 8 ]
Change History Complete list of historical versions of study NCT03561883 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2018)
  • Proportion of Overall Heartburn Responders Among Participants With a Baseline Weekly Heartburn Severity Score (WHSS) ≥ 3 [ Time Frame: Week 8 ]
  • Percent Change From Baseline to Week 8 in WHSS [ Time Frame: Baseline, Week 8 ]
  • Percent Change From Baseline to Week 8 in Weekly Regurgitation Frequency Score (WRFS) [ Time Frame: Baseline, Week 8 ]
  • Proportion of Heartburn-Free (Daily Heartburn Severity Score [DHSS]=0) Days During the 8-Week Treatment Period [ Time Frame: up to Week 8 ]
  • Proportion of Overall Regurgitation Responders [ Time Frame: up to Week 8 ]
  • Proportion of Days When Heartburn Did Not Occur (DHSS=0) or Was Very Mild (DHSS=1) During the 8-Week Treatment Period [ Time Frame: Week 8 ]
  • 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 Frame: Week 8 ]
  • Proportion of Regurgitation-Free (DRFS=0) Days During the 8-Week Treatment Period [ Time Frame: Week 8 ]
  • Change From Baseline to Week 8 in Each Modified Reflux Symptom Questionnaire Electronic Diary (mRESQ) Item [ Time Frame: Baseline, Week 8 ]
  • Proportion of Nights With Difficulty Falling Asleep Due to GERD During the 8-Week Treatment Period [ Time Frame: Week 8 ]
  • Proportion of Days With Nighttime Awakening Due to GERD During the 8-Week Treatment Period [ Time Frame: Week 8 ]
  • Number of Degree of Relief (of Heartburn/Regurgitation/Overall GERD Symptoms) Responders [ Time Frame: up to Week 8 ]
  • Change From Baseline to Week 8 in Heartburn/Regurgitation/Overall GERD Symptoms Bothersomeness [ Time Frame: Baseline, Week 8 ]
  • Proportion of Days With Rescue Medication Use During the 8-Week Treatment Period [ Time Frame: up to Week 8 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
  • Percent Change From Baseline to Week 8 in Weekly Heartburn Severity Score (WHSS) [ Time Frame: Baseline, Week 8 ]
  • Percent Change From Baseline to Week 8 in Weekly Regurgitation Frequency Score (WRFS) [ Time Frame: Baseline, Week 8 ]
  • Number of Overall Regurgitation Responders [ Time Frame: up to Week 8 ]
  • Percent of Days When Heartburn Did Not Occur (Daily Heartburn Severity Score [DHSS]=0) or Was Very Mild (DHSS=1) During Week 8 [ Time Frame: Week 8 ]
  • Percent of Days When Regurgitation Did Not Occur (Daily Regurgitation Frequency Scores [DRFS]=0) or Rarely Occurred (DRFS=1) During Week 8 [ Time Frame: Week 8 ]
  • Percent of Heartburn-Free (DHSS=0) Days During Week 8 [ Time Frame: Week 8 ]
  • Percent of Regurgitation-Free (DRFS=0) Days During Week 8 [ Time Frame: Week 8 ]
  • Change From Baseline to Week 8 in Each Modified Reflux Symptom Questionnaire Electronic Diary (mRESQ) Item [ Time Frame: Baseline, Week 8 ]
  • Percent of Nights With Difficulty Falling Asleep Due to GERD During Week 8 [ Time Frame: Week 8 ]
  • Percent of Days With Nighttime Awakening Due to GERD During Week 8 [ Time Frame: Week 8 ]
  • Number of Degree of Relief (of Heartburn/Regurgitation/Overall GERD Symptoms) Responders [ Time Frame: up to Week 8 ]
  • Change From Baseline to Week 8 in Heartburn/Regurgitation/Overall GERD Symptoms Bothersomeness [ Time Frame: Baseline, Week 8 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Gastroesophageal Reflux Disease (GERD)
Intervention  ICMJE
  • Drug: IW-3718
    oral tablet
  • Drug: placebo
    oral tablet
Study Arms  ICMJE
  • Experimental: 1500 mg IW-3718 BID
    Three 500 mg IW-3718 tablets administered twice daily (BID), immediately after the morning and evening meals.
    Intervention: Drug: IW-3718
  • Placebo Comparator: Placebo
    Three placebo tablets administered BID immediately after the morning and evening meals.
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2018)
660
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ironwood Study Team IW3718@ironwoodpharma.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03561883
Other Study ID Numbers  ICMJE C3718-302
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ironwood Pharmaceuticals, Inc.
Study Sponsor  ICMJE Ironwood Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Zurab Machaidze, MD Ironwood Pharmaceuticals, Inc.
PRS Account Ironwood Pharmaceuticals, Inc.
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP