CompletedPhase 3

Phase 3 Study of TAK-438 10 mg in the Treatment of Non-Erosive Gastroesophageal Reflux Disease (NERD)

Japan484 participantsStarted 2016-11-15

Plain-language summary

The purpose of this study was to evaluate the efficacy and safety of oral TAK-438 10 mg once-daily in the treatment of non-erosive gastroesophageal reflux disease (NERD).

Who can participate

Age range20 Years

SexALL

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Inclusion criteria

✓. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
✓. The participant signs and dates a written informed consent form prior to the initiation of any study procedures.
✓. The participant with NERD.
✓. The participant is endoscopically confirmed to have the modified Los Angeles (LA) Classification Grade N or M at the start of the run-in period (Visit 1).
✓. The participant experiences recurrent heartburn, on at least 2 days a week over the last 3 weeks prior to the start of the run-in period (Visit 1).
✓. The participant is either a male or female outpatient with a minimum age of 20 years at the time of informed consent signing. However, participants who are hospitalized only for examination purposes are also allowed to participate.
✓. A female participant of childbearing potential agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study, and for 4 weeks after the last dose of study drug.
✓. The participant's compliance to the study drug has been good (75% or better) in the run-in period.

Exclusion criteria

✕. The participant has received any investigational compound within 84 days prior to the first dose of study drug.
✕. The participant has received TAK-438 in a previous clinical study or as a therapeutic agent, except one with experience of receiving TAK-438 as an adjunct therapy for H. pylori eradication, who can be enrolled in this study.
✕. The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
✕. The participant has donated at least 400 mL of blood within the 90 days prior to the start of the run-in period (Visit 1).
✕. Endoscopic examination for entering this study fails to diagnose NERD within 84 days before the start of the run-in period (Visit 1).
✕. The participant has any complications affecting the esophagus, including Barrett's esophagus (3 cm or more, long segment Barrett's esophagus \[LSBE\]), eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, and esophageal stenosis; a history of radiation therapy or cryotherapy for the esophagus; or caustic or physiochemical trauma (eg, esophageal sclerotherapy). However, participants with Barrett's mucosa (less than 3 cm, short segment Barrett's esophagus \[SSBE\]) or Schatzki's ring (a mucosal tissue ring lining the inferior esophageal sphincter) are permitted to participate.
✕. The participant has a history of surgery or treatment affecting gastroesophageal reflux, including fundoplication and mechanical dilatation for esophageal stenosis (except Schatzki's ring), or a history of gastric or duodenal surgery (except endoscopic removal of benign polyps).
✕. The participant has acute upper gastrointestinal bleeding or gastric or duodenal ulcer, characterized by a defective mucosa with white coating, within 30 days prior to the start of the run-in period (Visit 1). However, participants with gastric or duodenal erosion are permitted to participate.

What they're measuring

Percentage of Days Without Symptoms of Heartburn

Timeframe: Up to Week 4

Cumulative Rate of Improvement in Symptoms of Heartburn

Timeframe: Day 0 to Day 24

Severity of Symptoms of Heartburn

Timeframe: Up to Week 4

Trial details

NCT IDNCT02954848

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-02-25

Results submitted2019-02-25

View on ClinicalTrials.gov More Non-erosive Gastroesophageal Reflux Disease trials