PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers
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|ClinicalTrials.gov Identifier: NCT01180179|
Recruitment Status : Active, not recruiting
First Posted : August 12, 2010
Last Update Posted : August 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peptic Ulcer||Drug: Lansoprazole Drug: Famotidine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||228 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Prevention of Recurrent Idiopathic Gastroduodenal Ulcer Bleeding: a Double-blind Randomized Trial|
|Actual Study Start Date :||June 2010|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||May 2019|
Active Comparator: Lansoprazole 30mg once daily
Lansoprazole 30mg once daily
30mg once daily
Active Comparator: Famotidine 40mg once daily
Famotidine 40mg once daily
40mg once daily
- Recurrent ulcer bleeding [ Time Frame: 24 months ]
According to prespecified criteria — hematemesis or melena documented by the admitting physician, or a decrease in the hemoglobin level of at least 2 g/dL, with ulcers or bleeding erosions confirmed on endoscopy.
A prespecified interim-analysis is performed on the primary endpoint when all patients have been randomised and have completed the 12 months follow-up. The interim-analysis is performed by an independent statistician, blinded for the treatment allocation. The statistician will report to the independent data and safety monitoring committee (DSMC). The DSMC will have unblinded access to all data and will discuss the results of the interim-analysis with the steering committee in a joint meeting. The steering committee decides on the continuation of the trial and will report to the central ethics committee. The Peto approach is used: the trial will be ended using symmetric stopping boundaries at P < 0.001.
- Recurrent ulcer detected by endoscopy at 24-month [ Time Frame: at the 24th month of follow-up ]Recurrent ulcer detected by endoscopy at 24-month, with or without clinical symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180179
|China, Hong Kong|
|Endoscopy Center, Prince of Wales Hospital, Shatin|
|Hongkong, Hong Kong, China|
|Principal Investigator:||Grace L Wong, MD||Chinese University of Hong Kong|