Clinical Trial With Mesalamine 1g Suppositories

NCT01172444 | Terminated Phase 3

• 1 other identifier: MESA-ULP3125
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 38

Brief Summary

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.

Conditions

Proctitis

Keywords

Mild to Moderate Ulcerative Proctitis

Outcome Measures

Primary Outcomes (1)

• DAI Score

  Mean difference in the DAI score between Baseline and the Final Visit.

  6 Weeks

Secondary Outcomes (1)

• DAI Score, Improvement, Remission & Histological Disease Activity Score

  3 and 6 Weeks

Study Arms (3)

Test

EXPERIMENTAL

Sandoz Mesalamine 1 g Suppository

Drug: Mesalamine

Reference

ACTIVE COMPARATOR

Canasa 1 g Suppository

Drug: Canasa

Placebo

PLACEBO COMPARATOR

Sandoz 1 g Placebo Suppository

Drug: Placebo

Interventions

Mesalamine DRUG

Supporitory, Once Daily, Per Rectal for 6 Weeks

Test

Canasa DRUG

Suppository, Once Daily, Per Rectal for 6 Weeks

Reference

Placebo DRUG

Suppository, Once Daily, Per Rectal for 6 Weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Sandoz: lead

Study Sites (38)

Kamineni Hospitals, 4-1-1227, King Koti Road, Abids

Hyderabad, Andhra Pradesh, 500 001, India

Location

Nizam's Instiute of Medical Sciences, Department of Gastroenterology

Hyderabad, Andhra Pradesh, 500 082, India

Location

Andhra Hospitals

Vijayawada, Andhra Pradesh, 520002, India

Location

Nagarjuna Hospitals Limited

Vijayawada, Andhra Pradesh, 520007, India

Location

Manikya Institute of Gastroenterology and Hepatology, MVV Chambers,203,204

Visakhapatnam, Andhra Pradesh, 530002, India

Location

Institute of Digestive and Liver Diseases

Guwahati, Assam, 781006, India

Location

Global Liver & Gastroenterology Centre, E-5/24, Opp Arera Petrol Pump

Arera Colony, Bhopal, India

Location

Indira Gandhi Institute of Medical Sciences

Sheikhpura, Patna, Bihar, 800014, India

Location

Department of Gastroenterology, Sheth V. S. General Hospital

Ahmedabad, Gujarat, 380006, India

Location

Ratandeep Surgical Hospital & Endoscopy Clinic

Ahmedabad, Gujarat, 380008, India

Location

Dr. Bhatnagar's Clinic

Ahmedabad, Gujarat, 380009, India

Location

Apollo Hospital International Ltd.

Ahmedabad, Gujarat, 382428, India

Location

Gastro Care Clinic

Rajkot, Gujarat, 360001, India

Location

Gastro Care

Surat, Gujarat, 395002, India

Location

Gokula Metropolis Clinical Research Center, M.S.Ramaiah Memorial Hospital, New BEL Road, MSRIT Post

Bangalore, Karnataka, 560 054, India

Location

PVS Memorial Hospital

Kochi, Kerala, 682017, India

Location

Sree Gokulam Medical College and Research Foundation

Thiruvanathapuram, Kerala, 695607, India

Location

Gut- N-Hepa Care

Indore, Madhya Pradesh, 452001, India

Location

KEM Hospital & Research Centre, Department of Surgery

Pune, Maharashtra, 411011, India

Location

Midas Institute of Gastroenterology

Rāmdaspeth, Nagpur, 440010, India

Location

Department of Gastroentrology, Postgraduate Institute of Medical Education & Research

Chandigarh, Punjab, 160012, India

Location

Dr. Nijhawan's Clinic

Jaipur, Rajasthan, 302017, India

Location

Sharma Gastroenterology Centre

Jaipur, Rajasthan, 302021, India

Location

Kala Endoscopy & Liver Clinic

Jodhpur, Rajasthan, 342001, India

Location

Apollo Speciality Hospitals, Lake View Road, K. K. Nagar

Madurai, Tamil Nadu, 625020, India

Location

Ajanta Hospital and IVF Center 765, ABC Complex , Kanpur Road

Alambagh, Lucknow, Uttar Pradesh, India

Location

C.S.M Medical University, Department of Surgical Gastroenterology, New Surgical Block (NSB)

Lucknow, Uttar Pradesh, 226003, India

Location

Dept. of Gastroenterology, Fortis Hospital, B-22, Sector-62

Noida, Uttar Pradesh, 20130, India

Location

Samvedna Hospital, B 27/88G, New Colony

Ravindrapuri, Varanasi, 221005, India

Location

Anand Multispeciality Hospitals Pvt Ltd, White house, Opp Rajasthan Hospital,Shahibaug

Ahmedabad, 380004, India

Location

Leads Medical Center, First Floor, Ozone Complex

Hyderabad, 500 082, India

Location

Dept. of Gastroenterology & Hepatology, Deccan College of Medical Sciences,Owaisi Hospital & Research Centre

Hyderabad, 500058, India

Location

RAI Speciality Care Centre

Jaipur, 342019, India

Location

School of Digestive and Liver Diseases, IPGME&R

Kolkata, 700020, India

Location

Gastroenterology and Endoscopy Center

Nagpur, 440012, India

Location

Senior Consultant-Gastroenterology and Hepatology, Indraprastha Apollo Hospitals

New Delhi, 110044, India

Location

Krishna Institute of Medical Sciences Ltd

Secunderabad, 500003, India

Location

Liver Clinic

Surat, 395002, India

Location

MeSH Terms

Conditions

Proctitis

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2010
• First Posted: July 29, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 27, 2017

Record last verified: 2015-07

Locations

IN (38)