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
- Registration Number
- CTRI/2010/091/000444
- Lead Sponsor
- Kemin Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
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 study
2.Male or non-pregnant female subjects 18-65 years of age, inclusive
3.A history of UC for at least 6 months prior to screening
4.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 period
7.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 screening
9.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 techniques
10.Otherwise in generally good health as judged by the investigator
1.Proctitis (<12 cm from the ano-rectal junction)
2.Indeterminate colitis
3.Crohn?s disease
4.Previous colonic surgery
5.Severe or fulminant UC [UCDAI >10] or requiring hospitalization
6.Evidence of other forms of inflammatory bowel disease
7.Subjects with a new diagnosis of UC
8.Subjects who altered their mesalazine/sulfasalazine dosage (dose regimen or dose) in the 2 weeks prior to screening
9.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 toxin
10.Subjects who have used the following medications within the specified period
a.Loperamide and other anti-diarrheal agents, probiotics, antibiotics: 1 week during run-in period
b.NSAIDs and COX-2 inhibitors, within 14 days from screening
c.Oral and injectable steroids, within 30 days from screening
d.Rectally administered mesalazine/sulfasalazine or other 5-ASAs or steroids, within 7 days from screening. Topical medications except for suppository and enemas are not excluded
e.Antivirals or antifungals within 30 days
f.Immunomodulating/suppressing drugs or biologicals (including anti TNF-α, cyclosporine, thalidomide, methotrexate) within 2 months
g.Sulfasalazine/mesalazine at higher dose than for maintenance treatment (higher than 2 g/day) within 30 days
11.Failing to respond to steroids within the previous year prior to screening
12.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 abuse
13.Needing enemas to treat their disease or to maintain remission
14.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 loss
15.Subjects whose UCDAI score decreases ≥2 during the 7-day run-in period
16.Allergy to aspirin or salicylate derivatives
17.Subject with a history of drug allergy in general or hypersensitivity to anti-inflammatory drugs
18.Participation in another clinical study within the last 3 months prior to screening
19.Inability to comply with the protocol requirements or to fill in the diary cards
20.Pregnancy or breast-feeding women or women of child-bearing potential not agreeing to birth control
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in UCDAI score after 8 weeks.Timepoint: at 8 weeks i.e. visit 3
- Secondary Outcome Measures
Name Time Method Change from baseline in partial UCDAI score.Timepoint: at week 2 (visit 1), week 4 (visit 2) and week 8 (visit 3);Disease specific quality of lifeTimepoint: 2nd 4th and 8th week;Proportion of subjects in remissionTimepoint: at week 8 and at end of treatment;Proportion of subjects with clinical responseTimepoint: 2nd, 4th and 8th week;SafetyTimepoint: 2nd, 4th and 8th week;Time to remission and number of treatment failuresTimepoint: At end of study