A Phase 3 interventional study of Esomeprazole and Placebo in Gastric Ulcer, Duodenal Ulcer and Rheumatoid Arthritis, sponsored by AstraZeneca. Completed at 39 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2010-05-28.
Sponsored by AstraZeneca · Phase 3, Interventional, and Prevention
The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers
112 studies on the registry are indexed under Stomach Ulcer; 13 are open to participants now.
This study's enrollment of 343 is above the median of 265 across 86 interventional studies indexed under Stomach Ulcer.
Browse Stomach Ulcer studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
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Exclusion Criteria:
Placebo
Drug: Placebo
Esomeprazole 20 mg
Drug: Esomeprazole
20mg once daily oral
Also known as: Nexium
once daily oral
Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period
The absence of gastric and/or duodenal ulcer throughout the treatment period
Time frame: each visit up to 24 weeks
Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment
Time frame: up to 4 weeks
Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment
Time frame: up to 12 weeks
343 randomised participants 341 in Full Analysis set and safety analysis set. Full set used for summaries of baseline char. and efficacy variables. Safety set used for summaries of safety variables. 2 excluded, took no investigational drug or had protocol deviation. 173 Esomeprazole 20 and 168 placebo had baseline information and were summarised.
| Milestone | Experimental: Esomeprazole 20 mg | Comparater: Placebo |
|---|---|---|
| Started | 175 | 168 |
| Completed | 134 | 90 |
| Not completed | 41 | 78 |
| Withdrew: Adverse event | 18 | 17 |
| Withdrew: Withdrawal by subject | 7 | 3 |
| Withdrew: Protocol violation | 8 | 1 |
| Withdrew: Recurrence of gastric ulcer | 8 | 57 |
The absence of gastric and/or duodenal ulcer throughout the treatment period
| Participants | Experimental: Esomeprazole 20 mg | Comparater: Placebo |
|---|---|---|
| Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period | 167 | 112 |
The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment
| Participants | Experimental: Esomeprazole 20 mg | Comparater: Placebo |
|---|---|---|
| Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment | 172 | 133 |
The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment
| Participants | Experimental: Esomeprazole 20 mg | Comparater: Placebo |
|---|---|---|
| Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment | 168 | 119 |
Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental: Esomeprazole 20 mg | — | 12/173 (6.9%) | 134/173 (77.5%) |
| Comparater: Placebo | — | 5/168 (3%) | 124/168 (73.8%) |
| Event | Experimental: Esomeprazole 20 mg | Comparater: Placebo |
|---|---|---|
| Faeces DiscolouredGastrointestinal disorders | 0/173 | 1/168 |
| Upper Gastrointestinal HaemorrhageGastrointestinal disorders | 0/173 | 1/168 |
| Gastroduodenal HaemorrhageGastrointestinal disorders | 0/173 | 1/168 |
| Pneumonia BacterialInfections and infestations | 0/173 | 1/168 |
| Gastric CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/173 | 1/168 |
| Oesophageal CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/173 | 1/168 |
| Haemorrhagic AnaemiaBlood and lymphatic system disorders | 0/173 | 1/168 |
| Colonic PolypGastrointestinal disorders | 1/173 | 0/168 |
| EnterocolitisGastrointestinal disorders | 1/173 | 0/168 |
| VomitingGastrointestinal disorders | 1/173 | 0/168 |
| Event | Experimental: Esomeprazole 20 mg | Comparater: Placebo |
|---|---|---|
| NasopharyngitisInfections and infestations | 27/173 | 27/168 |
| Abdominal Pain UpperGastrointestinal disorders | 18/173 | 22/168 |
| Stomach DiscomfortGastrointestinal disorders | 15/173 | 17/168 |
| Abdominal DistensionGastrointestinal disorders | 15/173 | 11/168 |
| Reflux OesophagitisGastrointestinal disorders | 10/173 | 13/168 |
| NauseaGastrointestinal disorders | 11/173 | 9/168 |
| AnorexiaMetabolism and nutrition disorders | 11/173 | 6/168 |
| DyspepsiaGastrointestinal disorders | 7/173 | 10/168 |
| DiarrhoeaGastrointestinal disorders | 9/173 | 6/168 |
| ConstipationGastrointestinal disorders | 7/173 | 5/168 |
| Age, Customized(participants) | Experimental: Esomeprazole 20 mg | Comparater: Placebo | Total |
|---|---|---|---|
| <65 years | 78 | 91 | 169 |
| Between 65 and 74 years | 59 | 54 | 113 |
| >=75 years | 36 | 23 | 59 |
| Missing | 2 | 0 | 2 |
| Sex/Gender, Customized(participants) | Experimental: Esomeprazole 20 mg | Comparater: Placebo | Total |
|---|---|---|---|
| Female | 108 | 100 | 208 |
| Male | 65 | 68 | 133 |
| Missing | 2 | 0 | 2 |
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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