Clinical Trial With Mesalamine 1g Suppositories

This study has been terminated.
(Enrollment difficulties)
Sponsor:
Information provided by:
Sandoz Inc.
ClinicalTrials.gov Identifier:
NCT01172444
First received: July 28, 2010
Last updated: September 21, 2012
Last verified: November 2010
  Purpose

An Investigator-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Establish Therapeutic Equivalence of 1000 mg Mesalamine Rectal Suppositories and Canasa® Rectal Suppositories (1000 mg Mesalamine, USP) in the Treatment of Mild to Moderate Ulcerative Proctitis will be conducted in 533 patient with a estimated duration of 18months.


Condition Intervention Phase
Proctitis
Drug: Mesalamine
Drug: Canasa
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: AN INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ESTABLISH THERAPEUTIC EQUIVALENCE OF 1000 mg MESALAMINE RECTAL SUPPOSITORIES AND CANASA® RECTAL SUPPOSITORIES (1000 mg MESALAMINE, USP) IN THE TREATMENT OF MILD TO MODERATE ULCERATIVE PROCTITIS

Resource links provided by NLM:


Further study details as provided by Sandoz Inc.:

Primary Outcome Measures:
  • DAI Score [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    Mean difference in the DAI score between Baseline and the Final Visit.


Secondary Outcome Measures:
  • DAI Score, Improvement, Remission & Histological Disease Activity Score [ Time Frame: 3 and 6 Weeks ] [ Designated as safety issue: No ]
    • The mean difference in the DAI score and each of the individual DAI parameters between Baseline, Interim and Final Visits
    • Proportion of patients achieving an "improvement", defined as a ≥3 point improvement in overall DAI score and the proportion of patients achieving a "remission", where "remission" is defined as a DAI score of 0-1 at the Interim and Final Visit.
    • The mean difference in the histological disease activity score between baseline and the Final Visit


Enrollment: 158
Study Start Date: June 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test
Sandoz Mesalamine 1 g Suppository
Drug: Mesalamine
Supporitory, Once Daily, Per Rectal for 6 Weeks
Active Comparator: Reference
Canasa 1 g Suppository
Drug: Canasa
Suppository, Once Daily, Per Rectal for 6 Weeks
Placebo Comparator: Placebo
Sandoz 1 g Placebo Suppository
Drug: Placebo
Suppository, Once Daily, Per Rectal for 6 Weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Adults, male and female, 18 to 65 years of age 2. Active, mild to moderate UP, with disease activity not to exceed 15 cm beyond the anal verge: the upper disease boundary will be confirmed by flexible sigmoidoscopy/colonoscopy performed within 14 days of the Baseline Visit 3. Newly diagnosed or newly relapsed UP, where newly relapsed UP is defined as UP that has relapsed within less than and equal to 6 weeks prior to the Baseline Visit 4. A Disease Activity Index (DAI) score greater than or equal to 4 and less than or equal to 10 at the Baseline Visit; the DAI must include a Physician's Global Assessment (PGA) sub-score of less than or equal to 2, a rectal bleeding sub-score of greater than or equal to 1 and a mucosal appearance sub-score of greater than or equal to 1 5. Histological confirmation of UP with a Histological Disease Activity Score > or equal to 1 for the biopsy taken from the most severe area of disease during the flexible sigmoidoscopy/colonoscopy performed within 14 days of the Baseline Visit 6. For female patients of child-bearing potential, a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit; all female patients will be considered of child-bearing potential unless they are post-menopausal for at least one year or have been surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) 7. Female patients of childbearing potential must be practicing one of the following methods of birth control and must agree to continue with regimen throughout the study: hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of one full cycle (based on the patient's usual menstrual cycle period) before investigational product administration; total abstinence from sexual intercourse (since the last menses before investigational product administration); intrauterine device; double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream); Male patients must also agree to use acceptable methods of birth control with their female partners, and this may include use of a male condom plus spermicide. 8. Ability to give written informed consent 9. Ability and willingness to comply with study requirements, including dosing procedures, diary completion, and study visits

Exclusion Criteria:

1. Known history of allergic reaction or clinically significant intolerance to aspirin or salicylate derivatives (including mesalamine) or non-active ingredients of the investigational product 2. Onset of UP relapse >6 weeks prior to the Baseline Visit for patients experiencing a relapse of their UP (i.e., patients who are not newly diagnosed) 3. Severe UP as defined by a DAI score of greater than or equal to 11 or a PGA sub-score of 3 4. Histological Disease Activity Score > or equal to 1 for the biopsy taken from the normal tissue above the disease margin during the flexible sigmoidoscopy/colonoscopy performed within 14 days of the Baseline Visit 5. UP with disease involvement greater than 15 cm beyond the anal verge as confirmed on flexible sigmoidoscopy/colonoscopy 6. Prior unsuccessful treatment of active UP or active ulcerative colitis with rectally administered mesalamine preparations of any strength 7. Any prior treatment of UP or ulcerative colitis with any oral 5-aminosalicylic acid product if used at >2 g/day, regardless of treatment outcome 8. Use of local, rectally administered therapies for UP or ulcerative colitis (e.g., suppositories or enemas containing mesalamine, etc.) within 30 days of the Baseline Visit 9. Use of any of the following medications: - Biological therapies (e.g., infliximab) within 90 days of the Baseline Visit - Immunosuppressive/immunomodulating (e.g., azathioprine) medications within 90 days of the Baseline Visit - Oral, intravenous, intramuscular, or rectally administered corticosteroids within 30 days of the Baseline Visit; the use of intranasal and/or inhaled corticosteroids is permitted - Oral 5-aminosalicylic acid products within 7 days of the Baseline Visit, if used at & less than or equal to 2 g/day - Oral, intravenous, or intramuscular antibiotics within 7 days of the Baseline Visit - Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within 7 days of the Baseline Visit; low-dose aspirin (less than or equal to 325 mg/day) taken for cardio-protective reasons is permitted - Antidiarrheals, antispasmodics, and iron therapy within 7 days of the Baseline Visit - Transdermal nicotine products within 7 days of the Baseline Visit 10. A change in regimen (i.e., dosage or frequency of use) of permitted medications within 30 days of the Baseline Visit, or any plans to change the regimen during the course of this study 11. Use or treatment with an investigational drug, therapy, or device within 30 days of the Baseline Visit 12. A planned change in tobacco usage (e.g., smoking, oral tobacco) during the study 13. Female patients who are pregnant, planning a pregnancy, or who are breastfeeding 14. Diseases interfering with the DAI assessment, including but not limited to, hemorrhoids and anal fissures 15. History of Crohn Disease, short bowel syndrome, or bowel surgery (except appendectomy), or active peptic ulcer 16. A positive stool culture for enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, Vibrio, E. coli O157/H7), detection of Clostridium difficile toxin through immunoassay, or enteric parasites and their ova (including Giardia, Cryptosporidium, and Entamoeba histolytica) on routine microscopy at the Screening Visit 17. Significant impairment of renal or hepatic function, as defined by any of the following: - Creatinine >1.5 x Upper Limit Normal (ULN) - Alanine Amino Transferase (ALT) >2.5 x ULN - Aspartate Amino Transferase (AST) >2.5 x ULN 18. Serologic positivity for the Hepatitis B virus (HBV), the Hepatitis C virus (HCV), the Human Immunodeficiency Virus (HIV), or Treponema pallidum (the causative agent of syphilis) 19. Known history of idiopathic / chronic pancreatitis 20. History of active drug or alcohol abuse within the past year, or physical examination findings indicating the same 21. Current clinically significant urinary tract obstruction 22. History of coagulation disorders, including those requiring treatment with anticoagulant drugs (except for aspirin taken at ≤325 mg/day for cardio-protective reasons 23. Current active malignancy or history of malignancy within the past five years, except for cervical carcinoma in situ, squamous or basal cell carcinoma of the skin that has been surgically removed, or prostate cancer that is being managed by watchful waiting (observation alone) 24. History of pelvic irradiation 25. Any other clinically significant abnormal medical condition that in the Investigators judgment would put the patient at increased risk of illness or injury, would interfere with study participation or would interfere with the evaluation or quality of the data 26. Inability or unwillingness to understand and comply with the requirements of the protocol for any reason, including dosing procedures and visit requirements 27. Previous randomization in this study

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172444

Locations
India
Kamineni Hospitals, 4-1-1227, King Koti Road, Abids
Hyderabad, Andhra Pradesh, India, 500 001
Nizam's Instiute of Medical Sciences, Department of Gastroenterology
Hyderabad, Andhra Pradesh, India, 500 082
Andhra Hospitals
Vijayawada, Andhra Pradesh, India, 520002
Nagarjuna Hospitals Limited
Vijayawada, Andhra Pradesh, India, 520007
Manikya Institute of Gastroenterology and Hepatology, MVV Chambers,203,204
Visakhapatnam, Andhra Pradesh, India, 530002
Institute of Digestive and Liver Diseases
Guwahati, Assam, India, 781006
Global Liver & Gastroenterology Centre, E-5/24, Opp Arera Petrol Pump
Arera Colony, Bhopal, India
Indira Gandhi Institute of Medical Sciences
Sheikhpura, Patna, Bihar, India, 800014
Department of Gastroenterology, Sheth V. S. General Hospital
Ahmedabad, Gujarat, India, 380006
Apollo Hospital International Ltd.
Ahmedabad, Gujarat, India, 382428
Dr. Bhatnagar's Clinic
Ahmedabad, Gujarat, India, 380009
Ratandeep Surgical Hospital & Endoscopy Clinic
Ahmedabad, Gujarat, India, 380008
Gastro Care Clinic
Rajkot, Gujarat, India, 360001
Gastro Care
Surat, Gujarat, India, 395002
Gokula Metropolis Clinical Research Center, M.S.Ramaiah Memorial Hospital, New BEL Road, MSRIT Post
Bangalore, Karnataka, India, 560 054
PVS Memorial Hospital
Cochin, Kerala, India, 682017
Sree Gokulam Medical College and Research Foundation
Thiruvanathapuram, Kerala, India, 695607
Gut- N-Hepa Care
Indore, Madhya Pradesh, India, 452001
KEM Hospital & Research Centre, Department of Surgery
Pune, Maharashtra, India, 411011
Midas Institute of Gastroenterology
Ramdaspeth, Nagpur, India, 440010
Department of Gastroentrology, Postgraduate Institute of Medical Education & Research
Chandigarh, Punjab, India, 160012
Dr. Nijhawan's Clinic
Jaipur, Rajasthan, India, 302017
Sharma Gastroenterology Centre
Jaipur, Rajasthan, India, 302021
Kala Endoscopy & Liver Clinic
Jodhpur, Rajasthan, India, 342001
Apollo Speciality Hospitals, Lake View Road, K. K. Nagar
Madurai, Tamil Nadu, India, 625020
Ajanta Hospital and IVF Center 765, ABC Complex , Kanpur Road
Alambagh, Lucknow, Uttar Pradesh, India
C.S.M Medical University, Department of Surgical Gastroenterology, New Surgical Block (NSB)
Lucknow, Uttar Pradesh, India, 226003
Dept. of Gastroenterology, Fortis Hospital, B-22, Sector-62
Noida, Uttar Pradesh, India, 20130
Samvedna Hospital, B 27/88G, New Colony
Ravindrapuri, Varanasi, India, 221005
Anand Multispeciality Hospitals Pvt Ltd, White house, Opp Rajasthan Hospital,Shahibaug
Ahmedabad, India, 380004
Dept. of Gastroenterology & Hepatology, Deccan College of Medical Sciences,Owaisi Hospital & Research Centre
Hyderabad, India, 500058
Leads Medical Center, First Floor, Ozone Complex
Hyderabad, India, 500 082
RAI Speciality Care Centre
Jaipur, India, 342019
School of Digestive and Liver Diseases, IPGME&R
Kolkata, India, 700020
Gastroenterology and Endoscopy Center
Nagpur, India, 440012
Senior Consultant-Gastroenterology and Hepatology, Indraprastha Apollo Hospitals
New Delhi, India, 110044
Krishna Institute of Medical Sciences Ltd
Secunderabad, India, 500003
Liver Clinic
Surat, India, 395002
Sponsors and Collaborators
Sandoz Inc.
  More Information

No publications provided

Responsible Party: Chandra S Vattikonda, M.Pharm., Ph.D., Sr. Director & Head, Clinical Development Center US, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT01172444     History of Changes
Other Study ID Numbers: MESA-ULP3125
Study First Received: July 28, 2010
Last Updated: September 21, 2012
Health Authority: India: Ministry of Health
United States: Institutional Review Board

Keywords provided by Sandoz Inc.:
Mild to Moderate Ulcerative Proctitis

Additional relevant MeSH terms:
Proctitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Rectal Diseases
Intestinal Diseases
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014