Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation

NCT ID: NCT01150162

Last Updated: 2013-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mucosta and Omeprazole

Group Type EXPERIMENTAL

Rebamipide and Omeprazole

Intervention Type DRUG

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

Omeperazole

Group Type ACTIVE_COMPARATOR

Omeprazole

Intervention Type DRUG

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

Interventions

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Rebamipide and Omeprazole

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

Intervention Type DRUG

Omeprazole

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

Intervention Type DRUG

Other Intervention Names

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Mucosta Omeprazole

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pakistan Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Laeeque Ahmed, Asst. Professor

Role: PRINCIPAL_INVESTIGATOR

Dr. Ziauddin University Hospital

Locations

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Abbasi Shaheed Hospital

Karachi, , Pakistan

Site Status

Dow University of Health Sciences

Karachi, , Pakistan

Site Status

Dr. Ziauddin University Hospital

Karachi, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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037-POA-0901i

Identifier Type: -

Identifier Source: org_study_id

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