Evaluation of Clinical Endpoints of Two Sucralfate suspension, 1g/10mL

Phase 3

Recruiting

• Conditions: duodenal ulcer patients

• Registration Number: CTRI/2013/04/003538
• Lead Sponsor: HiTech Pharmacal Co Inc

Brief Summary

This is a multicentre, randomized, double-blind, prospective, placebo controlled, three arm, parallel group comparison trial, evaluating the clinical bioequivalence of generic sucralfate oral suspension, 1g/10 mL with Carafate® suspension in patients with duodenal ulcer. The primary endpoint is the percentage of patients with endoscopically assessed DU healing after 56 ± 2 days of treatment (approximately 8 weeks); the secondary endpoints include percentage of patients with endoscopically assessed DU healing after 28 ± 2 days of treatment (approximately 4 Weeks), the use of antacid rescue medication, ulcer pain scores and occurrence of adverse events.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-04
• Last Update Posted: 2014-11-02

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 575

Inclusion Criteria

• Patient must have endoscopically confirmed active duodenal ulcer of at least 3 mm in diameter and not exceeding 25 mm.
• Patients must be confirmed H.pylori negative.
• Willingness to continue with current (baseline) behavior with respect to diet, smoking, alcohol and caffeine consumption throughout the study.
• 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

• 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.
• Presence of 1 or more chronic ulcers.
• Patients with more than two duodenal ulcers.
• Patients whose ulcer is due to other diseases (e.g. Zollinger-Ellison Syndrome).
• Patients with esophageal or gastric ulcers, or with active bleeding.
• Patients being treated with an H2 receptor antagonist, prostaglandin, antacids, proton pump inhibitors, or any other anti-ulcer medication.
• Requirement for continuing treatment with tetracyclines, or antimicrobial agents.
• Use of any investigational agent within 30 days of the first dose of study medication.
• Patients who have undergone previous gastric surgery, or who have previously experienced a perforated ulcer.
• Bleeding ulcer or a history of a bleeding ulcer within 1 year prior to enrollment.
• Presence of malignant lesions.
• Significant and uncontrolled hepatic, cardiac, renal, or endocrine dysfunction.
• 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.
• 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.
• History of alcoholism or drug abuse in the 2 years prior to the study.
• Any significant medical disorder that in the opinion of investigator, would preclude accurate evaluation of the patient’s condition.
• 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
demonstrating upper gastro intestinal endoscopically assessed Duodenal ulcer healing	[28 days], [56 days]

Secondary Outcome Measures

Name	Time	Method
1. The proportion of patients with endoscopically assessed DU healing after 28 ± 2 days of treatment	28 days
2. Ulcer pain, as evaluated by a 100 mm Visual Analog Scale (VAS) at each Visit	Week 2, Week 4, Week 6 and Week 8
3. Ulcer pain, as evaluated by daily pain scores	Week 2, Week 4, Week 6 and Week 8
4. The use of antacid rescue medication	Week 2, Week 4, Week 6 and Week 8

Trial Locations

Locations (30)

Aasha Endoscopy Centre; 🇮🇳 Kolhapur, MAHARASHTRA, India

Alka Hospital,; 🇮🇳 Ahmadabad, GUJARAT, India

Apex hospitals Pvt. Ltd; 🇮🇳 Jaipur, RAJASTHAN, India

Aster Aadhar Hospital; 🇮🇳 Kolhapur, MAHARASHTRA, India

Aware Global Hospitals; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Calcutta medical college and hospital,; 🇮🇳 Kolkata, WEST BENGAL, India

Cygnus (Aditya) Gastro Centre; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Dr Sanjeev S Chatni,; 🇮🇳 Dharwad, KARNATAKA, India

Dr. Vikas Sengar,Ratandeep Hospital & Research Centre; 🇮🇳 Dehat, UTTAR PRADESH, India

Gandhi Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

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Aasha Endoscopy Centre

🇮🇳Kolhapur, MAHARASHTRA, India

Dr Aneesh Amte

Principal investigator

aneeshamte.mcr@gmail.com