Mucosta in Gastric Ulcer Treatment, Effectiveness and Saf... | NCT01150162

Studies
Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation

NCT01150162

Sponsor

Otsuka Pakistan Limited

Status

Completed

Last Update Posted

Feb 4, 2013Estimated

Enrollment

129Actual

Phase

Phase 3

Conditions

Gastric Ulcer

Interventions

Rebamipide and Omeprazole
Omeprazole

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Jun 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Jun 23, 2010

First Submission Date that Met QC Criteria

Jun 23, 2010

First Posted Date

Jun 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2013

Last Update Posted Date

Feb 4, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

129Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mucosta and Omeprazole	Experimental		Drug: Rebamipide and Omeprazole
Omeperazole	Active Comparator		Drug: Omeprazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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	Mucosta and Omeprazole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
To determine and compare the Safety profile in both the treatment arms.		8 weeks treatment plus 4 weeks follow-up

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr. Laeeque Ahmed, Asst. Professor	Dr. Ziauddin University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abbasi Shaheed Hospital		Karachi			Pakistan
Dow University of Health Sciences

Condition Browse Module

MeSH Terms

ID	Term
D013276	Stomach Ulcer

Ancestor Terms

ID	Term
D010437	Peptic Ulcer
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C052785	rebamipide
D009853	Omeprazole

Ancestor Terms

ID	Term
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided