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

Sponsor

Takeda (Industry)

Overall Status

Completed

CT.gov ID

NCT01474369

Collaborator

(none)

827

Enrollment

Locations

Arms

14.1

Duration (Months)

15.9

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

827 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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.

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Percentage of symptom-free days of heartburn symptoms [Week 4]
Heartburn symptoms will be collected by participant diaries.
Cumulative symptom improvement rate of heartburn symptoms [Week 4]
Heartburn symptoms will be collected by participant diaries.
Severity of heartburn symptoms [Week 4]
Heartburn symptoms will be collected by participant diaries.

Secondary Outcome Measures

Heartburn symptoms stratified by response (improvement or non-improvement) at Week 2 [Week 4]
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) [Week 4]
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.) [Week 4]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	State	Country
1	Nagoya-shi	Aichi	Japan
2	Abiko-shi	Chiba	Japan
3	Kashiwa-shi	Chiba	Japan
4	Noda-shi	Chiba	Japan
5	Yachiyo-shi	Chiba	Japan
6	Saijo-shi	Ehime	Japan
7	Fukuoka-shi	Fukuoka	Japan
8	Itoshima-shi	Fukuoka	Japan
9	Kasuya-gun	Fukuoka	Japan
10	Onga-gun	Fukuoka	Japan
11	Kouriyama-shi	Fukushima	Japan
12	Gifu-shi	Gifu	Japan
13	Takayama-shi	Gifu	Japan
14	Annaka-shi	Gunma	Japan
15	Hiroshima-shi	Hiroshima	Japan
16	Asahikawa-shi	Hokkaido	Japan
17	Sapporo-shi	Hokkaido	Japan
18	Amagasaki-shi	Hyogo	Japan
19	Kobe-shi	Hyogo	Japan
20	Nishinomiya-shi	Hyogo	Japan
21	Takarazuka-shi	Hyogo	Japan
22	Sagamihara-shi	Kanagawa	Japan
23	Yokohama-shi	Kanagawa	Japan
24	Kochi-shi	Kochi	Japan
25	Suzaki-shi	Kochi	Japan
26	Kumamoto-shi	Kumamoto	Japan
27	Kyoto-shi	Kyoto	Japan
28	Sendai-shi	Miyagi	Japan
29	Nagasaki-shi	Nagasaki	Japan
30	Oita-shi	Oita	Japan
31	Okayama-shi	Okayama	Japan
32	Osaka-shi	Osaka	Japan
33	Takatsuki-shi	Osaka	Japan
34	Saga-shi	Saga	Japan
35	Kumagaya-shi	Saitama	Japan
36	Saitama-shi	Saitama	Japan
37	Tokorozawa-shi	Saitama	Japan
38	Otawara-shi	Tochigi	Japan
39	Bunkyo-ku	Tokyo	Japan
40	Chiyoda-ku	Tokyo	Japan
41	Chuo-ku	Tokyo	Japan
42	Hachioji-shi	Tokyo	Japan
43	Kokubunji-shi	Tokyo	Japan
44	Nakano-ku	Tokyo	Japan
45	Oota-ku	Tokyo	Japan
46	Setagaya-ku	Tokyo	Japan
47	Shibuya-ku	Tokyo	Japan
48	Shinjuku-ku	Tokyo	Japan
49	Shimonoseki-shi	Yamaguchi	Japan
50	Kofu-shi	Yamanashi	Japan
51	Turu-shi	Yamanashi	Japan
52	Yamagata-shi	Ymagata	Japan

Sponsors and Collaborators

Takeda

Investigators

Study Director: Senior Manager, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Takeda

ClinicalTrials.gov Identifier:

NCT01474369

Other Study ID Numbers:

TAK-438/CCT-201
U1111-1125-1115
JapicCTI-111663

First Posted:

Nov 18, 2011

Last Update Posted:

Jul 3, 2013

Last Verified:

Jul 1, 2013

Keywords provided by Takeda

Drug Therapy

Additional relevant MeSH terms:

Gastroesophageal Reflux

Esophagitis, Peptic

Study Results

No Results Posted as of Jul 3, 2013