Status:
COMPLETED
Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation
Lead Sponsor:
Otsuka Pakistan Limited
Conditions:
Gastric Ulcer
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT01150162
Start Date
October 1 2010
End Date
August 1 2012
Last Update
February 4 2013
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Abbasi Shaheed Hospital
Karachi, Pakistan
2
Dow University of Health Sciences
Karachi, Pakistan
3
Dr. Ziauddin University Hospital
Karachi, Pakistan