Efficacy of TAK-438 Compared to Placebo in the Treatment of Non-Erosive Gastroesophageal Reflux Disease
This study is currently recruiting participants.
Verified January 2013 by Takeda Global Research & Development Center, Inc.
Sponsor:
Takeda Pharmaceutical Company Limited
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier:
NCT01474369
First received: October 24, 2011
Last updated: January 17, 2013
Last verified: January 2013
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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 Global Research & Development Center, Inc.:
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.
| Estimated Enrollment: | 840 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | April 2013 |
| 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:
- Participants with grade N or M in the modified LA classification system confirmed by endoscopy at initiation of the pre-observation period (VISIT 1).
- 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).
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)
- Outpatients (hospitalization for testing possible)
Exclusion Criteria:
- 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.
- 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)
- 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.
- Participants with acute gastritis or acute exacerbation of chronic gastritis as a complication
- Participants with a previous or current history of the Zollinger-Ellison syndrome or other gastric acid hypersecretion disorders
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474369
Show 52 Study Locations
Contacts
| Contact: Takeda Study Registration Call Center | 800-778-2860 | medicalinformation@tpna.com |
Show 52 Study LocationsSponsors and Collaborators
Takeda Pharmaceutical Company Limited
Investigators
| Study Director: | Senior Manager | Takeda Pharmaceutical Company Limited |
More Information
No publications provided
| Responsible Party: | Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited ) |
| 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: | January 17, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Takeda Global Research & Development Center, Inc.:
|
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 May 16, 2013