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

NCT01474369 | Completed Phase 3

• 3 other identifiers: TAK-438/CCT-201U1111-1125-1115JapicCTI-111663
• Study Type: interventional
• Target: 827
• Locations: 1 country
• Sites: 52

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.

Conditions

Non-erosive Gastroesophageal Reflux Disease

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (3)

• Percentage of symptom-free days of heartburn symptoms

  Heartburn symptoms will be collected by participant diaries.

  Week 4

• Cumulative symptom improvement rate of heartburn symptoms

  Heartburn symptoms will be collected by participant diaries.

  Week 4

• Severity of heartburn symptoms

  Heartburn symptoms will be collected by participant diaries.

  Week 4

Secondary Outcomes (3)

• Heartburn symptoms stratified by response (improvement or non-improvement) at Week 2

  Week 4

• Heartburn Symptoms Stratified by Baseline Endoscopic Findings (Grade N or M)

  Week 4

• 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

Study Arms (3)

TAK-438 10 mg QD

EXPERIMENTAL

Drug: TAK-438

TAK-438 20 mg QD

EXPERIMENTAL

Drug: TAK-438

Placebo QD

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TAK-438 DRUG

TAK-438 10 mg, tablets, orally, once daily for 4 weeks. Thereafter, TAK-438 placebo tablets, orally, once daily for 1 week.

TAK-438 10 mg QD

Placebo DRUG

TAK-438 placebo-matching tablets, orally, once daily for 5 weeks.

Placebo QD

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Takeda: lead

Study Sites (52)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

Unknown Facility

Abiko-shi, Chiba, Japan

Location

Unknown Facility

Kashiwa-shi, Chiba, Japan

Location

Unknown Facility

Noda, Chiba, Japan

Location

Unknown Facility

Yachiyo-shi, Chiba, Japan

Location

Unknown Facility

Saijo-shi, Ehime, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Unknown Facility

Itoshima-shi, Fukuoka, Japan

Location

Unknown Facility

Kasuya-gun, Fukuoka, Japan

Location

Unknown Facility

Onga-gun, Fukuoka, Japan

Location

Unknown Facility

Kouriyama-shi, Fukushima, Japan

Location

Unknown Facility

Gifu, Gifu, Japan

Location

Unknown Facility

Takayama-shi, Gifu, Japan

Location

Unknown Facility

Annaka-shi, Gunma, Japan

Location

Unknown Facility

Hiroshima, Hiroshima, Japan

Location

Unknown Facility

Asahikawa-shi, Hokkaido, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Amagasaki-shi, Hyōgo, Japan

Location

Unknown Facility

Kobe, Hyōgo, Japan

Location

Unknown Facility

Nishinomiya-shi, Hyōgo, Japan

Location

Unknown Facility

Takarazuka-shi, Hyōgo, Japan

Location

Unknown Facility

Sagamihara-shi, Kanagawa, Japan

Location

Unknown Facility

Yokohama, Kanagawa, Japan

Location

Unknown Facility

Kochi, Kochi, Japan

Location

Unknown Facility

Suzaki-shi, Kochi, Japan

Location

Unknown Facility

Kumamoto, Kumamoto, Japan

Location

Unknown Facility

Kyoto, Kyoto, Japan

Location

Unknown Facility

Sendai, Miyagi, Japan

Location

Unknown Facility

Nagasaki, Nagasaki, Japan

Location

Unknown Facility

Ōita, Oita Prefecture, Japan

Location

Unknown Facility

Okayama, Okayama-ken, Japan

Location

Unknown Facility

Osaka, Osaka, Japan

Location

Unknown Facility

Takatsuki-shi, Osaka, Japan

Location

Unknown Facility

Saga, Saga-ken, Japan

Location

Unknown Facility

Kumagaya-shi, Saitama, Japan

Location

Unknown Facility

Saitama-shi, Saitama, Japan

Location

Unknown Facility

Tokorozawa-shi, Saitama, Japan

Location

Unknown Facility

Otawara-shi, Tochigi, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, Japan

Location

Unknown Facility

Chiyoda-ku, Tokyo, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, Japan

Location

Unknown Facility

Hachioji-shi, Tokyo, Japan

Location

Unknown Facility

Kokubunji-shi, Tokyo, Japan

Location

Unknown Facility

Nakano-ku, Tokyo, Japan

Location

Unknown Facility

Oota-ku, Tokyo, Japan

Location

Unknown Facility

Setagaya-ku, Tokyo, Japan

Location

Unknown Facility

Shibuya-ku, Tokyo, Japan

Location

Unknown Facility

Shinjuku-ku, Tokyo, Japan

Location

Unknown Facility

Shimonoseki-shi, Yamaguchi, Japan

Location

Unknown Facility

Kofu, Yamanashi, Japan

Location

Unknown Facility

Turu-shi, Yamanashi, Japan

Location

Unknown Facility

Yamagata, Ymagata, Japan

Location

Related Publications (1)

• Kinoshita Y, Sakurai Y, Shiino M, Kudou K, Nishimura A, Miyagi T, Iwakiri K, Umegaki E, Ashida K. Evaluation of the Efficacy and Safety of Vonoprazan in Patients with Nonerosive Gastroesophageal Reflux Disease: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study. Curr Ther Res Clin Exp. 2016 Dec 21;81-82:1-7. doi: 10.1016/j.curtheres.2016.12.001. eCollection 2016.

  PMID: 28119763 DERIVED

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine

Study Officials

• Senior Manager

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: November 18, 2011
• Study Start: December 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: July 3, 2013

Record last verified: 2013-07

Locations

JP (52)