Gastric UlcerPhase 3MGESNCT01150162
Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation
A Phase 3 study testing Rebamipide and Omeprazole and Omeprazole in people with Gastric Ulcer, run by Otsuka Pakistan Limited at 3 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastric Ulcer
- What is being tested?
- Rebamipide and Omeprazole and Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 3 sitesPakistan
- Study dates
- Oct 2010to Aug 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Pakistan3 sites
Abbasi Shaheed Hospital
Karachi
Dow University of Health Sciences
Karachi
Dr. Ziauddin University Hospital
Karachi
About this study
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
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.
- Conditions
- Gastric Ulcer
- Being tested
- Rebamipide and Omeprazole, Omeprazole
- Medical subject headings
- Stomach Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebamipide and OmeprazoleDrug
Also called Mucosta, Omeprazole
open label, oral route, Rebamipide, 100mg tablet t.i.d and Omeprazole 20 mg tablet B.I.D. for 8 weeks
OmeprazoleDrug
open label,oral route, Omeprazole 20mg tablet, B. I.D.; alone, for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mucosta and Omeprazole | Experimental | Not described Receives: Drug: Rebamipide and Omeprazole |
| Omeperazole | Active comparator | Not described Receives: Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing rates for gastric ulcer patients via endoscopic examination
Measured: 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.
Measured: 8 weeks treatment plus 4 weeks follow-up
Secondary outcomes (1)
To determine and compare the Safety profile in both the treatment arms.
Measured: 8 weeks treatment plus 4 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pakistan Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Laeeque Ahmed, Asst. Professor, Principal investigator, Dr. Ziauddin University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150162
- Sponsor's protocol ID
- 037-POA-0901i
- Acronym
- MGES
- Status last verified
- Feb 2013
- First submitted
- 23 Jun 2010
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01150162
- Acronym / sponsor ID
- MGES / 037-POA-0901i
- Conditions
- Gastric Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Otsuka Pakistan LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 24 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mucosta and Omeprazole | Experimental | Drug: Rebamipide and Omeprazole |
| Omeperazole | Active comparator | Drug: Omeprazole |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rebamipide and OmeprazoleAlso: Mucosta, Omeprazoleopen label, oral route, Rebamipide, 100mg tablet t.i.d and Omeprazole 20 mg tablet B.I.D. for 8 weeks | Drug | Mucosta and Omeprazole |
| Omeprazoleopen label,oral route, Omeprazole 20mg tablet, B. I.D.; alone, for 8 weeks | Drug | Omeperazole |
Primary outcome
Healing rates for gastric ulcer patients via endoscopic examination
Time frame: 8 weeks treatment plus 4 weeks follow-up
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.
1 secondary outcome
To determine and compare the Safety profile in both the treatment arms.
Time frame: 8 weeks treatment plus 4 weeks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
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SPADE Clinical Trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Laeeque Ahmed, Asst. Professor principal investigator
Dr. Ziauddin University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rebamipide and Omeprazole and Omeprazole in people with Gastric Ulcer, run by Otsuka Pakistan Limited at 3 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing rates for gastric ulcer patients via endoscopic examination (time frame: 8 weeks treatment plus 4 weeks follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2013.