Evaluation of Clinical Endpoints of Two Sucralfate suspension, 1g/10m
- Conditions
- Health Condition 1: null- duodenal ulcer patients
- Registration Number
- CTRI/2013/04/003538
- Lead Sponsor
- HiTech Pharmacal Co Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 575
1. Patient must have endoscopically confirmed active duodenal ulcer of at least 3 mm in
diameter and not exceeding 25 mm. 2. Patients must be confirmed H.pylori negative. 3. Willingness to continue with current (baseline) behavior with respect to diet, smoking, alcohol and caffeine consumption throughout the study.
4. Patient must sign an IRB/IEC-approved written Informed Consent Form (ICF), which
includes agreement to comply with all study requirements as indicated in the protocol,
including a negative urine pregnancy test at time of entry (if a female of child-bearing
potential).
1. Regular use of therapeutic dose of any non-steroidal anti-inflammatory drug (NSAID)
during the study period or within 8 weeks prior to the baseline endoscopy.
2. Presence of 1 or more chronic ulcers. 3. Patients with more than two duodenal ulcers.
4. Patients with antral, pre-pyloric (more than 1 cm proximal to the pyloric channel) or post-bulbar lesions despite possible concomitant lesions in the duodenum.
5. Patients whose ulcer is due to other diseases (e.g. Zollinger-Ellison Syndrome).
6. Patients with esophageal or gastric ulcers, or with active bleeding.
7. Patients being treated with an H2 receptor antagonist, prostaglandin, antacids, proton pump inhibitors, or any other anti-ulcer medication.
8. Requirement for continuing treatment with tetracyclines, or antimicrobial agents.
9. Use of any investigational agent within 30 days of the first dose of study medication.
10. Patients who have undergone previous gastric surgery, or who have previously
experienced a perforated ulcer.
11. Co-existent pyloric stenosis, gastric outlet obstruction, or grade II or III esophagitis.
12. Bleeding ulcer or a history of a bleeding ulcer within 1 year prior to enrollment.
13. Presence of malignant lesions.
14. Significant and uncontrolled hepatic, cardiac, renal, or endocrine dysfunction.
15. A baseline serum aluminum concentration above upper limit of the normal range in the
presence of abnormal renal function or an
aluminum concentration at baseline that is greater than 2.5 times the upper limit of the
normal range in a patient with normal renal function.
16. Patients who have undergone major trauma or surgery within the previous four weeks or
patients scheduled to undergo surgery during the period of time covered by the study.
17. History of alcoholism or drug abuse in the 2 years prior to the study.
18. Any significant medical disorder that in the opinion of investigator, would preclude
accurate evaluation of the patientâ??s condition.
19. Females who are pregnant or lactating or planning pregnancy during the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method