A Phase 3 interventional study of Esomeprazole and Esomeprazole in Reflux Esophagitis, sponsored by AstraZeneca. Completed at 44 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2010-06-17.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily by assessment of presence/absence of recurrence of Reflux Esophagitis throughout the treatment period (from the randomisation to the treatment completion) according to the Los Angeles classification.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 540 is above the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
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Exclusion Criteria:
Esomeprazole and Omeprazole
Drug: Esomeprazole · Drug: Omeprazole
Esomeprazole
Drug: Esomeprazole
10mg once daily oral administration
Also known as: Nexium
20mg once daily oral administration
Also known as: Nexium
10mg once daily oral administration
Also known as: Prilosec
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period.
Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D throughout the treatment period was evaluated.
Time frame: Up to 24 weeks
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment
Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 4 weeks after treatment was evaluated.
Time frame: up to 4 weeks
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment
Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 12 weeks after treatment was evaluated.
Time frame: Up to 12 weeks
Enrolment 8Jan08-19May09. 564 randomised participants, 563 in Full Analysis set and safety analysis set. FAS used for summaries of baseline characteristics and efficacy. SAS for summaries of safety. 1 pt. in Omep. 10 mg excluded as they took no investigational drug. Nos. for gender were 188 in Esom. 20 mg, 188 in Esom. 10 mg and 187 in Omep. 20 mg.
| Milestone | Experimental: Esomeprazole 20 mg | Experimental: Esomeprazole 10 mg | Comparator: Omeprazole 10 mg |
|---|---|---|---|
| Started | 188 | 189 | 187 |
| Completed | 160 | 154 | 148 |
| Not completed | 28 | 35 | 39 |
| Withdrew: Adverse event | 6 | 8 | 3 |
| Withdrew: Withdrawal by subject | 9 | 6 | 11 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
| Withdrew: Protocol violation | 3 | 3 | 1 |
| Withdrew: Pregnancy | 1 | 0 | 0 |
| Withdrew: Incorrect enrolment | 0 | 1 | 0 |
| Withdrew: Recurrence of reflux esophagitis | 5 | 15 | 21 |
| Withdrew: Difficult to continue | 3 | 1 | 1 |
| Withdrew: Other reason | 1 | 1 | 1 |
Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 4 weeks after treatment was evaluated.
| Participants | Experimental: Esomeprazole 20 mg | Experimental: Esomeprazole 10 mg | Comparator: Omeprazole 10 mg |
|---|---|---|---|
| Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment | 184 | 180 | 171 |
Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D throughout the treatment period was evaluated.
| Participants | Experimental: Esomeprazole 20 mg | Experimental: Esomeprazole 10 mg | Comparator: Omeprazole 10 mg |
|---|---|---|---|
| Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period. | 174 | 166 | 156 |
Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 12 weeks after treatment was evaluated.
| Participants | Experimental: Esomeprazole 20 mg | Experimental: Esomeprazole 10 mg | Comparator: Omeprazole 10 mg |
|---|---|---|---|
| Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment | 179 (NA to NA) | 172 (NA to NA) | 163 (NA to NA) |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental: Esomeprazole 20 mg | — | 5/188 (2.7%) | 71/188 (37.8%) |
| Experimental: Esomeprazole 10 mg | — | 4/188 (2.1%) | 69/188 (36.7%) |
| Comparator: Omeprazole 10 mg | — | 1/187 (0.5%) | 34/187 (18.2%) |
| Event | Experimental: Esomeprazole 20 mg | Experimental: Esomeprazole 10 mg | Comparator: Omeprazole 10 mg |
|---|---|---|---|
| ConstipationGastrointestinal disorders | 0/188 | 0/188 | 1/187 |
| Colonic polypGastrointestinal disorders | 1/188 | 1/188 | 0/187 |
| OesophagitisGastrointestinal disorders | 1/188 | 0/188 | 0/187 |
| Hand fractureInjury, poisoning and procedural complications | 0/188 | 1/188 | 0/187 |
| Subdural haematomaInjury, poisoning and procedural complications | 0/188 | 1/188 | 0/187 |
| Pancreatic carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/188 | 0/188 | 0/187 |
| Small intestine carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/188 | 1/188 | 0/187 |
| TachyarrhythmiaCardiac disorders | 1/188 | 0/188 | 0/187 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 1/188 | 0/188 | 0/187 |
| Event | Experimental: Esomeprazole 20 mg | Experimental: Esomeprazole 10 mg | Comparator: Omeprazole 10 mg |
|---|---|---|---|
| NasopharyngitisInfections and infestations | 31/188 | 37/188 | 31/187 |
| Abdominal pain upperGastrointestinal disorders | 11/188 | 3/188 | 4/187 |
| DiarrhoeaGastrointestinal disorders | 4/188 | 7/188 | 7/187 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 2/188 | 2/188 | 5/187 |
| Blood creatine phosphokinase increasedInvestigations | 5/188 | 5/188 | 2/187 |
| Blood pressure increasedInvestigations | 1/188 | 5/188 | 1/187 |
| ContusionInjury, poisoning and procedural complications | 5/188 | 0/188 | 2/187 |
| ConstipationGastrointestinal disorders | 2/188 | 1/188 | 4/187 |
| Abdominal distensionGastrointestinal disorders | 0/188 | 0/188 | 4/187 |
| Upper respiratory tract infectionInfections and infestations | 4/188 | 1/188 | 0/187 |
| Age, Customized(Participants) | Experimental: Esomeprazole 20 mg | Experimental: Esomeprazole 10 mg | Comparator: Omeprazole 10 mg | Total |
|---|---|---|---|---|
| <65 | 131 (131 to NA) | 131 (131 to NA) | 137 (137 to NA) | 399 (0 to 0) |
| 65-74 | 45 (45 to NA) | 41 (41 to NA) | 38 (38 to NA) | 124 (0 to 0) |
| >=75 | 12 (12 to NA) | 16 (16 to NA) | 12 (12 to NA) | 40 (0 to 0) |
| Missing | 0 (0 to NA) | 1 (1 to NA) | 0 (0 to NA) | 1 (0 to 0) |
| Sex/Gender, Customized(Participants) | Experimental: Esomeprazole 20 mg | Experimental: Esomeprazole 10 mg | Comparator: Omeprazole 10 mg | Total |
|---|---|---|---|---|
| Female | 46 (142 to NA) | 51 (137 to NA) | 42 (145 to NA) | 139 (0 to 0) |
| Male | 142 (46 to NA) | 147 (51 to NA) | 145 (42 to NA) | 434 (0 to 0) |
| Missing | 0 (0 to NA) | 1 (1 to NA) | 0 (0 to NA) | 1 (0 to 0) |
This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.
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