Health Condition 1: null- duodenal ulcer patients
Conditions
Interventions
Intervention1: Generic Sucralfate oral suspension, 1 g/10 mL: The suspension will be administered at a dose of 10 mL four times daily for up to 56 days
Control Intervention1: Carafate oral suspension,
Sponsors
HiTech Pharmacal Co Inc
Novel Laboratories Inc
Eligibility
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| demonstrating upper gastro intestinal endoscopically assessed Duodenal ulcer healingTimepoint: [28 days], [56 days] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of patients with endoscopically assessed DU healing after 28 ± 2 days of treatmentTimepoint: 28 days;2. Ulcer pain, as evaluated by a 100 mm Visual Analog Scale (VAS) at each VisitTimepoint: Week 2, Week 4, Week 6 and Week 8;3. Ulcer pain, as evaluated by daily pain scoresTimepoint: Week 2, Week 4, Week 6 and Week 8;4. The use of antacid rescue medicationTimepoint: Week 2, Week 4, Week 6 and Week 8 | — |
Countries
India
Contacts
Public ContactR Arulprakash
Sristek Clinical Research Organization
Outcome results
None listed