Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation

Last updated: February 1, 2013
Sponsor: Otsuka Pakistan Limited
Overall Status: Completed

Phase

3

Condition

Ulcers

Colic

Stomach Discomfort

Treatment

N/A

Clinical Study ID

NCT01150162
037-POA-0901i
  • Ages 18-65
  • All Genders

Study 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

Inclusion Criteria:

  • Patients with dyspepsia or epigastric pain and endoscopically proven gastric andduodenal ulcers

  • Required laboratory parameters and time limits (screening blood tests will be takenincluding 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 toregistration in study

Exclusion

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 studyperiod

Study Design

Total Participants: 129
Study Start date:
October 01, 2010
Estimated Completion Date:
August 31, 2012

Connect with a study center

  • Abbasi Shaheed Hospital

    Karachi,
    Pakistan

    Site Not Available

  • Dow University of Health Sciences

    Karachi,
    Pakistan

    Site Not Available

  • Dr. Ziauddin University Hospital

    Karachi,
    Pakistan

    Site Not Available

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