Clinical trial NCT01669811: Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)
Official title: A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of D961H 20 mg Twice Daily Oral Administration and D961H 20 mg Once Daily Oral Administration in Patients With Refractory Reflux Esophagitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Refractory Reflux Esophagitis
Keywords: Refractory Reflux Esophagitis,
Japanese,
Nexium,
twice daily,
oral administration
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-08-21
Enrollment: 1398
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: This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory reflux esophagitis after 8 weeks of standard Proton-pump inhibitor (PPI) therapy by assessment of presence/absence of inflammation (esophagitis) at Week 8 according to the Los Angeles (LA) classification

Detailed description: A multicentre, randomised, double-blind, parallel-group, comparative study to compare the efficacy and safety of D961H 20 mg twice daily oral administration and D961H 20 mg once daily oral administration in patients with refractory reflux esophagitis

Eligibility criteria: Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures.
2. Patients with RE classified into LA classification Grade A, B, C or D by Endoscopy despite of at least 8-week treatment using standard doses of PPIs.
3. Patients must fulfill at least one of the following criteria such as (i) RE with LA grade C/D at Endoscopy on visit 1 and/or history of RE with LA grade C/D, (ii) RE was diagnosed more than 1 year before visit 1.
4. Patients who are able to complete the Patient Diary

Exclusion Criteria:

1. Male or female aged less than 20 years at the time of informed consent.
2. Patients with current evidence of the gastrointestinal diseases/conditions such as esophageal stricture to interfere with the evaluation of the study etc
3. Gastric or duodenal ulcer verified by Endoscopy within 12 weeks before randomisation.
4. Previous esophageal, gastric or duodenal surgery except simple closure of perforated ulcer, simple endoscopic treatment with simple operation etc
5. Current or historical evidence (within 12 weeks prior to randomisation) of the diseases/conditions as judged to interfere with the evaluation of the study.

Primary outcomes:
measure: Percentage of Participants With Healing of RE Who Were Graded "O" at Week 8 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification
timeFrame: 8 Weeks
Secondary outcomes:
measure: Percentage of Participants With Healing of RE Who Were Graded "O" at Week 4 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification
timeFrame: 4 Weeks
measure: Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Heartburn at Week 4
timeFrame: 4 Weeks
measure: Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Acid Regurgitation at Week 4
timeFrame: 4 Weeks
measure: Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Abdominal Pain at Week 4
timeFrame: 4 Weeks
measure: Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Difficulty of Swallowing at Week 4
timeFrame: 4 Weeks
measure: Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Sleep Disturbance at Week 4
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Abiko-shi
country: Japan
facility: Research Site
city: Adachi-ku
country: Japan
facility: Research Site
city: Annaka-shi
country: Japan
facility: Research Site
city: Asahikawa-shi
country: Japan
facility: Research Site
city: Asakura-shi
country: Japan
facility: Research Site
city: Beppu-shi
country: Japan
facility: Research Site
city: Bunkyo-ku
country: Japan
facility: Research Site
city: Chuo-ku
country: Japan
facility: Research Site
city: Fujiidera-shi
country: Japan
facility: Research Site
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Fukushima-shi
country: Japan
facility: Research Site
city: Gifu-shi
country: Japan
facility: Research Site
city: Hamamatsu-shi
country: Japan
facility: Research Site
city: Hirakata-shi
country: Japan
facility: Research Site
city: Hitachi-shi
country: Japan
facility: Research Site
city: Ibara-shi
country: Japan
facility: Research Site
city: Ichiki-Kushikino-shi
country: Japan
facility: Research Site
city: Ishikari-shi
country: Japan
facility: Research Site
city: Iwata-shi
country: Japan
facility: Research Site
city: Izumo-shi
country: Japan
facility: Research Site
city: Kagoshima-shi
country: Japan
facility: Research Site
city: Kamakura-shi
country: Japan
facility: Research Site
city: Kanazawa-shi
country: Japan
facility: Research Site
city: Karatsu-shi
country: Japan
facility: Research Site
city: Kawasaki-shi
country: Japan
facility: Research Site
city: Kirishima-shi
country: Japan
facility: Research Site
city: Kita-ku
country: Japan
facility: Research Site
city: Kobe-shi
country: Japan
facility: Research Site
city: Kochi-shi
country: Japan
facility: Research Site
city: Koga-shi
country: Japan
facility: Research Site
city: Koriyama-shi
country: Japan
facility: Research Site
city: Kumagaya-shi
country: Japan
facility: Research Site
city: Kumamoto-shi
country: Japan
facility: Research Site
city: Kyoto-shi
country: Japan
facility: Research Site
city: Machida-shi
country: Japan
facility: Research Site
city: Matsumoto-shi
country: Japan
facility: Research Site
city: Meguro-ku
country: Japan
facility: Research Site
city: Moriguchi-shi
country: Japan
facility: Research Site
city: Nishinomiya-shi
country: Japan
facility: Research Site
city: Ogori-shi
country: Japan
facility: Research Site
city: Oita-shi
country: Japan
facility: Research Site
city: Okayama-shi
country: Japan
facility: Research Site
city: Osaka-shi
country: Japan
facility: Research Site
city: Ota-ku
country: Japan
facility: Research Site
city: Otawara-shi
country: Japan
facility: Research Site
city: Saga-shi
country: Japan
facility: Research Site
city: Saitama-shi
country: Japan
facility: Research Site
city: Sakaide-shi
country: Japan
facility: Research Site
city: Saku-shi
country: Japan
facility: Research Site
city: Sapporo-shi
country: Japan
facility: Research Site
city: Sendai-shi
country: Japan
facility: Research Site
city: Shibuya-ku
country: Japan
facility: Research Site
city: Shinagawa-ku
country: Japan
facility: Research Site
city: Shinjuku-ku
country: Japan
facility: Research Site
city: Takasaki-shi
country: Japan
facility: Research Site
city: Takatsuki-shi
country: Japan
facility: Research Site
city: Toshima-ku
country: Japan
facility: Research Site
city: Toyama-shi
country: Japan
facility: Research Site
city: Uji-shi
country: Japan
facility: Research Site
city: Wakayama-shi
country: Japan
facility: Research Site
city: Yanagawa-shi
country: Japan
facility: Research Site
city: Yokohama-shi
country: Japan
facility: Research Site
city: Yufu-shi
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca, Moelndal, Sweden
name: Tore Lind, MSD
role: STUDY_DIRECTOR
affiliation: AstraZeneca, Osaka, Japan
name: Lan Chen
role: STUDY_DIRECTOR
affiliation: Dept of Gastroenterology and Hepatology, Shimane, Japan
name: Yoshikazu Kinoshita, PROFESSOR OF MEDICINE
role: PRINCIPAL_INVESTIGATOR
References: