Trial | NCT01150162  Report issue

Title

Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation
A Prospective Randomized, Multi-center Study to Assess the Safety and Efficacy of Mucosta (Rebamipide), in Combination With Omeprazole as Adjuvant Therapy in Gastric Ulcer Patients

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    129
A Prospective Randomized, Multi-center study to assess the Safety and Efficacy of Mucosta (Rebamipide), in combination with Omeprazole as adjuvant therapy in Gastric Ulcer Patients.
Study Started
Oct 31
2010
Primary Completion
Jun 30
2012
Study Completion
Aug 31
2012
Last Update
Feb 04
2013
Estimate

Drug Rebamipide and Omeprazole

open label, oral route, Rebamipide, 100mg tablet t.i.d and Omeprazole 20 mg tablet B.I.D. for 8 weeks

  • Other names: Mucosta, Omeprazole

Drug Omeprazole

open label,oral route, Omeprazole 20mg tablet, B. I.D.; alone, for 8 weeks

Mucosta and Omeprazole Experimental

Omeperazole Active Comparator

Criteria 

Inclusion Criteria:

Patients with dyspepsia or epigastric pain and endoscopically proven gastric and duodenal ulcers
Required laboratory parameters and time limits (screening blood tests will be taken including hemoglobin, white blood cell count, random glucose, potassium, sodium, chlorine, creatinine, AST, ALT, bilirubin, and alkaline phosphatase)
Age > 18 years
A statement that all patients must have signed an informed consent form prior to registration in study

Exclusion Criteria:

Patients who had undergone surgery for ulcers
History of hypersensitivity to drugs to be used in the study
Women who are pregnant or lactating or intended to get pregnant during the study period
No Results Posted