A placebo controlled clinical trial to evaluate safety and efficacy of two doses of AM 3301 for add-on treatment of mild to moderate active ulcerative colotis

Phase 2

Completed

Conditions: Mild to moderate ulcerative colitis

Registration Number: CTRI/2010/091/000444

Lead Sponsor: Kemin Pharma

Brief Summary: This study is multicentric, randomized, double blind placebo controlled study to evaluate two dosages of AM 3301 for add-on treatment of mild to moderate active ulcerative colitis.A total 180 subjects will be enrolled and randomized to 3 treatment arms in 1:1:1 ratio. Primary endpoint would be change from baseline UCDAI score to week 8 UCDAI score. In addition disease specific Quality of life and safethy of the study medication would be evaluated. The run in period is of 1 week and treatment period is of 8 weeks. The anticipated date of enrollment is 1st June 2010.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

1.Must sign and date written informed consent prior to any study-related procedures and, in the opinion of the investigator, be willing and likely to comply with all requirements of the study2.Male or non-pregnant female subjects 18-65 years of age, inclusive3.A history of UC for at least 6 months prior to screening4.All subjects must have clinical and endoscopic confirmed diagnosis of active mild to moderate UC with disease extension beyond the rectum (>12 cm from the ano-rectal junction):5.Confirmed by obligatory colonoscopy/ endoscopy at screening: full report to be available and score >2 (at least moderate friability)6.Ulcerative Colitis Disease Activity Index [UCDAI] of 5-10, inclusive, as assessed on screening (based on retrospective recall by the subject over the previous 3 days) and to be confirmed after 7 days of baseline observation, before inclusion in the randomization procedure, and not improving ≥2 score points during the baseline period7.Duration of current relapse less than 6 weeks from screening (according to subject)8.Oral mesalazine/sulfasalazine maintenance therapy (<2g/day) for no less than 30 days prior to screening9.Females of childbearing potential require a negative urine pregnancy test and must agree to abstinence or to use prescription contraceptives and to use a barrier contraceptive device along with a spermicidal product for the duration of the study.
Subjects who are surgically sterile, menopausal or using contraceptive implants prior to the study enrolment are not required to utilize dual contraceptive techniques10.Otherwise in generally good health as judged by the investigator.

Exclusion Criteria

1.Proctitis (<12 cm from the ano-rectal junction)2.Indeterminate colitis3.Crohn?s disease4.Previous colonic surgery5.Severe or fulminant UC [UCDAI >10] or requiring hospitalization6.Evidence of other forms of inflammatory bowel disease7.Subjects with a new diagnosis of UC8.Subjects who altered their mesalazine/sulfasalazine dosage (dose regimen or dose) in the 2 weeks prior to screening9.Subjects with a positive stool culture for any enteric pathogens that is clinically significant, pathogenic ova or parasites, or a positive EIA that is subsequently confirmed by a positive cytotoxin assay for C.
difficile toxin10.Subjects who have used the following medications within the specified perioda.Loperamide and other anti-diarrheal agents, probiotics, antibiotics: 1 week during run-in periodb.NSAIDs and COX-2 inhibitors, within 14 days from screeningc.Oral and injectable steroids, within 30 days from screeningd.Rectally administered mesalazine/sulfasalazine or other 5-ASAs or steroids, within 7 days from screening.
Topical medications except for suppository and enemas are not excludede.Antivirals or antifungals within 30 daysf.Immunomodulating/suppressing drugs or biologicals (including anti TNF-α, cyclosporine, thalidomide, methotrexate) within 2 monthsg.Sulfasalazine/mesalazine at higher dose than for maintenance treatment (higher than 2 g/day) within 30 days11.Failing to respond to steroids within the previous year prior to screening12.Subjects who have any other clinically significant disease(s) which, in the opinion of the investigator, could compromise the subject?s involvement in the study or overall interpretation of the data, such as mental/emotional disorder, dysplasia or cancer, seropositivity for HIV, HCV, uncontrolled hematologic, renal, hepatic, metabolic pulmonary or cardiovascular disease and active alcohol or drug abuse13.Needing enemas to treat their disease or to maintain remission14.Subjects with abnormal laboratory values at admission which are clinically significant by the investigator (outlier values outside the normal values are allowed and to be marked as ?NCS?
if considered Not Clinically Significant (NCS) by the investigator based on the nature of the disease.
Quite some UC subjects have an aberrant immune response and abnormal laboratory values due to the impaired absorption, and blood loss15.Subjects whose UCDAI score decreases ≥2 during the 7-day run-in period16.Allergy to aspirin or salicylate derivatives17.Subject with a history of drug allergy in general or hypersensitivity to anti-inflammatory drugs18.Participation in another clinical study within the last 3 months prior to screening19.Inability to comply with the protocol requirements or to fill in the diary cards20.Pregnancy or breast-feeding women or women of child-bearing potential not agreeing to birth control.

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in UCDAI score after 8 weeks.	at 8 weeks i.e. visit 3

Secondary Outcome Measures

Name	Time	Method
Change from baseline in partial UCDAI score.	at week 2 (visit 1), week 4 (visit 2) and week 8 (visit 3)
Proportion of subjects in remission	at week 8 and at end of treatment
Proportion of subjects with clinical response	2nd, 4th and 8th week
Disease specific quality of life	2nd 4th and 8th week
Safety	2nd, 4th and 8th week
Time to remission and number of treatment failures	At end of study

Trial Locations

Locations (14): Aakash Clinic, 2, Ratnam Apartment, Sampat Rao Colony, Opposite Neptune Tower, Productivity Road, Vadodara-390005, Gujarat, India, Ph-0265-2334103, ID.drashishsethi@hotmail.com
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India
Choithram Hospital and Research Centre, Manik Bagh Road, Indore-452014, Madhya Pradesh, India, Ph-0731-236249, ID.ajayvjain@yahoo.com, Fax-0731-2470068
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India
Dayanand Medical College & Hospital, Tagore Nagar, Civil Lines, Ludhiana-141001, Punjab, India, Ph-0161-2301749, ID.ajitsood10@sify.com, Fax-0161-2300791
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India
Department of Gastroenterology and Hepatology, Deccan College of Medical Sciences, Kanchanbagh, Hyderabad-500058, Andhra Pradesh, India, Ph-040-24342954, ID.aejazhabeeb@hotmail.com, Fax-040-24342954
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India
Department of Surgery, Faculty Block Next to Library, Goa Medical College, Bambolim, Goa-403202, India, Ph-0832-2495275, ID.dr.rpatil@rediffmail.com, Fax-0832-2458728
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India
Department of Surgical Gastroenterology, Chhatrapati Shahuji Maharaja Medical University, Lucknow-226003, Uttar Pradesh, India, Ph-0522-2258660, ID.abhijitchandra@hotmail.com, Fax-0522-2258982
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India
Dr. Sandeep Nijhawan Clinic, 112, Panchsheel Enclave, Gokul Bhai Bhatt Marg, Durgapura, Jaipur-302017, Rajasthan, India, Ph-9829272233, ID.nijhawan@yahoo.com, Fax-0141-2575466
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India
Gastro Care Clinic, Karansinhji Main Road, Opposite to Dr. Bharat Parekh Hospital, Rajkot-360001, Gujarat, India, Ph-0281-2235010, ID.mehtacn@hotmail.com, Fax-0281-2232112
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India
Jagmohan Hospital, Behind Old High Court, Navrangpura, Ahmedabad-380009, Gujarat, India, Ph-9824026626, ID.drdevalparikh@gmail.com, Fax-079-27545111
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India
Liver Clinic 203-204, Narmada Complex, Near Kadiwala School, Ring Road, Surat-395002, Gujarat, India, Ph-0261-2464290, ID.rmgastro@yahoo.com, Fax-0261-2464296
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India
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Aakash Clinic, 2, Ratnam Apartment, Sampat Rao Colony, Opposite Neptune Tower, Productivity Road, Vadodara-390005, Gujarat, India, Ph-0265-2334103, ID.drashishsethi@hotmail.com
🇮🇳India
Dr. Ashish Sethi
Principal investigator