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NCT Number: NCT01150162

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.

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Key information

Conditions

Gastric Ulcer Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases Stomach Ulcer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Abbasi Shaheed Hospital, Karachi, Pakistan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rebamipide and Omeprazole

Drug

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

Omeprazole

Drug

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

Primary outcomes

  1. Healing rates for gastric ulcer patients via endoscopic examination

    Time frame: 8 weeks treatment plus 4 weeks follow-up

  2. Improvement or absence of gastric ulcer associated symptoms

    Time frame: 8 weeks treatment plus 4 weeks follow-up

    Improvement or absence of gastric ulcer associated symptoms, i.e. pain, burning, etc.

Secondary outcomes

  1. To determine and compare the Safety profile in both the treatment arms.

    Time frame: 8 weeks treatment plus 4 weeks follow-up

Sponsors and collaborators

Lead sponsor

Otsuka Pakistan Limited

Industry

Registry information

Official study title

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

Acronym: MGES

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 24, 2010
Registry last updated
Feb 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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