Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation
MGES
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
1 other identifier
interventional
129
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2010
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2010
CompletedFirst Posted
Study publicly available on registry
June 24, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFebruary 4, 2013
February 1, 2013
1.7 years
June 23, 2010
February 1, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Healing rates for gastric ulcer patients via endoscopic examination
8 weeks treatment plus 4 weeks follow-up
Improvement or absence of gastric ulcer associated symptoms
Improvement or absence of gastric ulcer associated symptoms, i.e. pain, burning, etc.
8 weeks treatment plus 4 weeks follow-up
Secondary Outcomes (1)
To determine and compare the Safety profile in both the treatment arms.
8 weeks treatment plus 4 weeks follow-up
Study Arms (2)
Mucosta and Omeprazole
EXPERIMENTALOmeperazole
ACTIVE COMPARATORInterventions
open label, oral route, Rebamipide, 100mg tablet t.i.d and Omeprazole 20 mg tablet B.I.D. for 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Abbasi Shaheed Hospital
Karachi, Pakistan
Dow University of Health Sciences
Karachi, Pakistan
Dr. Ziauddin University Hospital
Karachi, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Laeeque Ahmed, Asst. Professor
Dr. Ziauddin University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2010
First Posted
June 24, 2010
Study Start
October 1, 2010
Primary Completion
June 1, 2012
Study Completion
August 1, 2012
Last Updated
February 4, 2013
Record last verified: 2013-02