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RECLAIM

Trial

Clinical Trial Title

RECLAIM

Trial Status

Open to Enrollment

Start Date

January 1, 2019

Trial Type

Gastroenterology

Specific Condition

GERD

Description

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).

Experimental:  Three 500 mg study drug tablets administered twice daily (BID), immediately after the morning and evening meals.

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


Eligibility Criteria

Ages Eligible for Study:  18 years and older
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, 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.


IRB Number

10823

Principal Investigator Name

Harald Schoeppner, MD

Contact Name

Paul Fitzpatrick

Phone

503-413-7094

Contact Fax

503-413-6861

Contact E-Mail

pfitzpatri@lhs.org

Last Updated: Thursday, December 5, 2019 08:22:08 AM