Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Gastric Ulcer |
| Intervention | Drug: Rebamipide and Omeprazole Drug: Omeprazole |
| Phase | Phase 3 |
| Sponsor | Otsuka Pakistan Limited |
| Responsible Party | Otsuka Pakistan Limited |
| ClinicalTrials.gov Identifier | NCT01150162 |
| First Received | June 23, 2010 |
| Last Updated | February 1, 2013 |
| Last verified | February 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 23, 2010 |
|---|---|
| Last Updated Date | February 1, 2013 |
| Start Date | October 2010 |
| Estimated Primary Completion Date | August 2012 |
| Current Primary Outcome Measures |
|
| Current Secondary Outcome Measures | To determine and compare the Safety profile in both the treatment arms. [Time Frame: 8 weeks treatment plus 4 weeks follow-up] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation |
|---|---|
| Official 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 |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Gastric Ulcer |
| Intervention | Drug: Rebamipide and Omeprazole open label, oral route, Rebamipide, 100mg tablet t.i.d and Omeprazole 20 mg tablet B.I.D. for 8 weeks Other Names:
open label,oral route, Omeprazole 20mg tablet, B. I.D.; alone, for 8 weeks |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 129 |
| Estimated Completion Date | August 2012 |
| Estimated Primary Completion Date | June 2012 |
| Eligibility Criteria | 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Pakistan |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01150162 |
|---|---|
| Other Study ID Numbers | 037-POA-0901i |
| Has Data Monitoring Committee | No |
| Information Provided By | Otsuka Pakistan Limited |
| Study Sponsor | Otsuka Pakistan Limited |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Dr. Laeeque Ahmed, Asst. Professor Dr. Ziauddin University Hospital |
| Verification Date | February 2013 |
Locations[ + expand ][ + ]
| Dr. Ziauddin University Hospital | Karachi, Pakistan |
|---|---|
| Dow University of Health Sciences | Karachi, Pakistan |
| Abbasi Shaheed Hospital | Karachi, Pakistan |