Efficacy of TAK-438 Compared to Placebo in the Treatment of Non-Erosive Gastroesophageal Reflux Disease

Non-erosive Gastroesophageal Reflux Disease Clinical Trial

Official title:

A Phase 3, Randomized, Double Blind, Placebo Control, Multicenter Study to Evaluate the Efficacy and Safety of TAK- 438 (10 and 20 mg Once-Daily) in Patients With Non-Erosive Gastroesophageal Reflux Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474369
• Other study ID #: TAK-438/CCT-201
• Secondary ID: U1111-1125-1115J
• Status: Completed
• Phase: Phase 3
• First received: October 24, 2011
• Last updated: July 2, 2013
• Start date: December 2011
• Est. completion date: February 2013

Study information

• Verified date: July 2013
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the superiority of efficacy of TAK-438, once daily (QD), to placebo in patients with non-erosive gastroesophageal reflux disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 827
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Participants with grade N or M in the modified LA classification system confirmed by endoscopy at initiation of the pre-observation period (VISIT 1).

2. Participants with repeated acid reflux symptoms (heartburn or regurgitation) for 2 days or more in one week in the 3 weeks before initiation of initiation of the pre-observation period (VISIT 1).

3. Participants with severity* of moderate or higher for acid reflux symptoms (heartburn or regurgitation) in the 3 weeks before initiation of the pre-observation period (VISIT 1)

• Severity: No symptoms, very mild (symptoms present but often forgotten), mild (not so painful), moderate (rather painful), severe (painful) and very severe (painful enough to affect night time sleep or daily activities)

4. Outpatients (hospitalization for testing possible)

Exclusion Criteria:

1. Participants with an esophagus-related complication [Barrett's esophagus (3 cm or more, LSBE), eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infections, esophageal stenosis, etc.], or a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Barrett's esophagus (less than 3 cm, SSBE) or Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) are allowed to be included.

2. Participants who have received surgery or treatment affecting gastroesophageal reflux (cardioplasty, dilation of esophageal stenosis [excluding Schatzki's ring], etc.), or who have a history of surgery of stomach or duodenum (excluding removal of benign polyp under endoscopy)

3. Participants who have acute upper gastrointestinal bleeding, gastric ulcers (mucosal defects associated with white coating) or duodenal ulcers (mucosal defect with white coating) within 30 days before initiation of the pre-observation period (VISIT 1) However, participants with gastric or duodenal erosions are allowed to be included.

4. Participants with acute gastritis or acute exacerbation of chronic gastritis as a complication

5. Participants with a previous or current history of the Zollinger-Ellison syndrome or other gastric acid hypersecretion disorders

6. Participants with a history of chest pain due to heart disease or with chest pains suspected of being caused by heart disease within one year before initiation of the pre-observation period (VISIT 1)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Non-erosive Gastroesophageal Reflux Disease

Intervention

Drug:
• TAK-438
TAK-438 10 mg, tablets, orally, once daily for 4 weeks. Thereafter, TAK-438 placebo tablets, orally, once daily for 1 week.
• TAK-438
TAK-438 20 mg, tablets, orally, once daily for 4 weeks. Thereafter, TAK-438 placebo tablets, orally, once daily for 1 week.
• Placebo
TAK-438 placebo-matching tablets, orally, once daily for 5 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of symptom-free days of heartburn symptoms	Heartburn symptoms will be collected by participant diaries.	Week 4	No
Primary	Cumulative symptom improvement rate of heartburn symptoms	Heartburn symptoms will be collected by participant diaries.	Week 4	No
Primary	Severity of heartburn symptoms	Heartburn symptoms will be collected by participant diaries.	Week 4	No
Secondary	Heartburn symptoms stratified by response (improvement or non-improvement) at Week 2	Heartburn symptoms will be collected by participant diaries. Percentage of symptom-free days, cumulative symptom improvement rate, and severity of heartburn symptoms are evaluation parameters.	Week 4	No
Secondary	Heartburn Symptoms Stratified by Baseline Endoscopic Findings (Grade N or M)	Heartburn symptoms collected by participant diaries. Percentage of symptom-free days, cumulative symptom improvement rate and severity of heartburn symptoms=evaluation parameters. Participants with Non-Erosive Gastroesophageal Reflux Disease divided into Grade N (endoscopically normal) and M (minimal change) by modified Los Angeles Classification System. Grade definitions: Grade N (endoscopically normal), M (minimal change), A (Mucosal break <5 mm) B (Mucosal break =5 mm) C (Mucosal break continuous between 2 or more folds and <75% of circumference) and D (Mucosal break =75% of circumference).	Week 4	No
Secondary	Heartburn symptoms stratified by combination of response at Week 2 and baseline endoscopic findings (improvement and grade N, improvement and grade M, non-improvement and grade N, non-improvement and grade M.)	Heartburn symptoms will be collected by participant diaries. Percentage of symptom-free days, cumulative symptom improvement rate, and severity of heartburn symptoms are evaluation parameters.	Week 4	No