Clinical trial NCT01474369: Efficacy of TAK-438 Compared to Placebo in the Treatment of Non-Erosive Gastroesophageal Reflux Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-erosive Gastroesophageal Reflux Disease
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-11-18
Enrollment: 827
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Percentage of symptom-free days of heartburn symptoms
timeFrame: Week 4
measure: Cumulative symptom improvement rate of heartburn symptoms
timeFrame: Week 4
measure: Severity of heartburn symptoms
timeFrame: Week 4
Secondary outcomes:
measure: Heartburn symptoms stratified by response (improvement or non-improvement) at Week 2
timeFrame: Week 4
measure: Heartburn Symptoms Stratified by Baseline Endoscopic Findings (Grade N or M)
timeFrame: Week 4
measure: 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.)
timeFrame: Week 4
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
state: Aichi
city: Abiko-shi
country: Japan
state: Chiba
city: Kashiwa-shi
country: Japan
state: Chiba
city: Noda-shi
country: Japan
state: Chiba
city: Yachiyo-shi
country: Japan
state: Chiba
city: Saijo-shi
country: Japan
state: Ehime
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Itoshima-shi
country: Japan
state: Fukuoka
city: Kasuya-gun
country: Japan
state: Fukuoka
city: Onga-gun
country: Japan
state: Fukuoka
city: Kouriyama-shi
country: Japan
state: Fukushima
city: Gifu-shi
country: Japan
state: Gifu
city: Takayama-shi
country: Japan
state: Gifu
city: Annaka-shi
country: Japan
state: Gunma
city: Hiroshima-shi
country: Japan
state: Hiroshima
city: Asahikawa-shi
country: Japan
state: Hokkaido
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Amagasaki-shi
country: Japan
state: Hyogo
city: Kobe-shi
country: Japan
state: Hyogo
city: Nishinomiya-shi
country: Japan
state: Hyogo
city: Takarazuka-shi
country: Japan
state: Hyogo
city: Sagamihara-shi
country: Japan
state: Kanagawa
city: Yokohama-shi
country: Japan
state: Kanagawa
city: Kochi-shi
country: Japan
state: Kochi
city: Suzaki-shi
country: Japan
state: Kochi
city: Kumamoto-shi
country: Japan
state: Kumamoto
city: Kyoto-shi
country: Japan
state: Kyoto
city: Sendai-shi
country: Japan
state: Miyagi
city: Nagasaki-shi
country: Japan
state: Nagasaki
city: Oita-shi
country: Japan
state: Oita
city: Okayama-shi
country: Japan
state: Okayama
city: Osaka-shi
country: Japan
state: Osaka
city: Takatsuki-shi
country: Japan
state: Osaka
city: Saga-shi
country: Japan
state: Saga
city: Kumagaya-shi
country: Japan
state: Saitama
city: Saitama-shi
country: Japan
state: Saitama
city: Tokorozawa-shi
country: Japan
state: Saitama
city: Otawara-shi
country: Japan
state: Tochigi
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Chiyoda-ku
country: Japan
state: Tokyo
city: Chuo-ku
country: Japan
state: Tokyo
city: Hachioji-shi
country: Japan
state: Tokyo
city: Kokubunji-shi
country: Japan
state: Tokyo
city: Nakano-ku
country: Japan
state: Tokyo
city: Oota-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Shibuya-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Shimonoseki-shi
country: Japan
state: Yamaguchi
city: Kofu-shi
country: Japan
state: Yamanashi
city: Turu-shi
country: Japan
state: Yamanashi
city: Yamagata-shi
country: Japan
state: Ymagata
Study officials:
affiliation: Takeda
name: Senior Manager
role: STUDY_DIRECTOR
References:
citation: 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.