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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01474369
First received: October 24, 2011
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Non-erosive Gastroesophageal Reflux Disease
Drug: TAK-438
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Percentage of symptom-free days of heartburn symptoms [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Heartburn symptoms will be collected by participant diaries.

  • Cumulative symptom improvement rate of heartburn symptoms [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Heartburn symptoms will be collected by participant diaries.

  • Severity of heartburn symptoms [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Heartburn symptoms will be collected by participant diaries.


Secondary Outcome Measures:
  • Heartburn symptoms stratified by response (improvement or non-improvement) at Week 2 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.

  • Heartburn Symptoms Stratified by Baseline Endoscopic Findings (Grade N or M) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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).

  • 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.) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.


Enrollment: 827
Study Start Date: December 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAK-438 10 mg QD 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.
Experimental: TAK-438 20 mg QD Drug: 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 Comparator: Placebo QD Drug: Placebo
TAK-438 placebo-matching tablets, orally, once daily for 5 weeks.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474369

  Show 52 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: Senior Manager Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01474369     History of Changes
Other Study ID Numbers: TAK-438/CCT-201, U1111-1125-1115, JapicCTI-111663
Study First Received: October 24, 2011
Last Updated: July 2, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014