Evaluation of Clinical Endpoints of Two Sucralfate suspension, 1g/10mL
Scientific Title of Study
A Multi-Center, Double Blind, Placebo-Controlled, Randomized, Parallel-Group
Study To Evaluate The Safety And Clinical Equivalence of a Generic Sucralfate
Oral Suspension, 1g/10ml (Hi-Tech Pharmacal Co., Inc., USA) To Carafate®
Suspension, 1g/10ml (Aptalis Pharma, Inc., [Formerly Axcan Pharma US, Inc.,
USA]) in the Treatment of Active Duodenal Ulcer Disease
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
DU/SUF/01/2010
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Dr. Anumula Kavita, Dept. of Gastroenterology
Guntur Medical College & Govt. General Hospital,
Kannavarithota,
Guntur- 522004
Andhra Pradesh Guntur ANDHRA PRADESH
9399977555
jananigastro@ymail.com
DrBhabadev Goswami
Institute of Digestive and Liver Diseases
Institute of Digestive and Liver Diseases, Dispur Hospitals Pvt. Ltd., Ganeshguri, Guwahati- 781006, Assam, India Kamrup ASSAM
913612221962
bhabadev@rediffmail.com
Dr Gopal Krishna Dhali
Institute of Post Graduate Medical Education & Research Centre (IPGMER)
Institute of Post Graduate Medical Education & Research Centre (IPGMER), Room No.17, 4th Floor, Ronald Ross Buidling, ALC Bose Road, Kolkata - 20, West Bengal, India Kolkata WEST BENGAL
913322234744
gkdhali@yahoo.co.in
Dr Nandesh
JSS Hospital,
JSS Hospital,
Department of Clinical Pharmacy,
Agrahara, MG Road, Mysore, 570004,
Karnataka, India.
Mysore KARNATAKA
9845197828
nandesh_gastro@yahoo.co.in
Dr BV Tantry
Kasturba Medical College Hospital,
Kasturba Medical College Hospital,Ambedkar Circle, Manglore-2425092 Dakshina Kannada KARNATAKA
08242444590
tantrybv@gmail.com
Dr Nagarjuna Yarlagada
Krishna Institute of Medical Sciences (KIMS)
Krishna Institute of Medical Sciences (KIMS), 1-8-3-1/1, Minister Road, , Secunderabad - 500003, Andhra Pradesh, India, Hyderabad ANDHRA PRADESH
914044186343
nagarjun@sify.com
Dr Sandeep Kumar Gupta
M V Hospital & Research Centre
MV Hospital and Research Centre
314/30, Mirza Mandi, Chowk, Lucknow UTTAR PRADESH
9415026054
sandeepkumar.gupta@rediffmail.com
Dr Murali Krishna
Manikya Institute of Gasteroenterology and Hepatology
Manikya Institute of Gasteroenterology and Hepatology, MVV Chambers, Near KGH OP Gate Bus Stop, Maharanipeta Visakhapatnam- 530002
Andhra Pradesh
Visakhapatnam ANDHRA PRADESH
Dr.Chetan Mehta, Giriraj Hospital Research Ethics Commitee, 150 ft ring road 27, Navyjot Park main road,Amin MArg Cross Road, Rajkot 360005
Approved
Dr.Hasmukh Vora, Sangini Hospital Ethics Commitee. C/O Sangini Hospital, 2nd floor, snagini Complex, Near doctor house, parimal crossing, Ahmedabad
Approved
Dr.Nagarjuna.Institutional ethics committee of KIMS Foundation research center,Krishna Institute of Medical Sciences,1-8-31/,Ministers road,Secunderabad-500003,AP,India.
The suspension will be administered at a dose of 10 mL four times daily for up to 56 days
Intervention
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
Comparator Agent
Placebo suspension
The suspension will be administered at a dose of 10 mL four times daily for up to 56 days.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
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).
ExclusionCriteria
Details
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 patient’s condition.
19. Females who are pregnant or lactating or planning pregnancy during the study.
Method of Generating Random Sequence
Permuted block randomization, fixed
Method of Concealment
On-site computer system
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
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
Target Sample Size
Total Sample Size="575" Sample Size from India="575" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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.