A clinical trial conducted to determine the safety and tolerability of ORE1001 in patient suffering with Ulcerative Colitis.
- Registration Number
- CTRI/2010/091/000097
- Lead Sponsor
- ORE Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 50
INCLUSION CRITERIA
1. Does the subject have a documented diagnosis of Ulcerative Colitis as demonstrated clinically and histologically?
2.Is the Modified Baron Score greater than or equal to 2 at baseline?
3.Is the Truelove-Witts (modified) Score equal or less than 14?
4.Does the subject have a minimum of 6 months duration of the disease?
5.Does the subject have a stable clinical disease condition either without prescription therapy or with 5-Amino Salicylic Acid (5-ASA) treatment?
6.If on 5 ASA-treatment, is the subject on a stable dose for at least 2 weeks prior to this visit and willing to continue on the same regimen until the study is completed?
7.Does the subject have normally functioning major organ systems (aside from Gastro-intestinal Tract) as indicated by past medical history, vital signs, physical examination and clinical laboratory results including hematology, coagulation, clinical chemistry and urinalysis?
8. Is the subject aged between 18-70 years?
9.Has the subject provided voluntary written informed consent to participate in this study?
10.If female of child-bearing potential, not pregnant, not nursing, not planning a pregnancy for the duration of the study and has a negative pregnancy test prior to enrollment?
11.a) Does the subject agree to use a method of birth control from screening until 30 days post final dose of study drug?
b) Do female partners of male subjects enrolled into the study also agree to use an acceptable method of birth control?
c) Do the male subjects agree to not donate sperm during the entire course of the study and for 90 days after the last dose of study drug?
1.Does a clinically significant medical history, medical finding or an ongoing medical or psychiatric condition exist which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of treatment according to the protocol?
2. Does the subject meet exclusion criteria for Alanine Aminotransferase (ALT) or have a serum creatinine greater than 1.5 times the upper limit of normal?
3. Is the subject in the opinion of the investigator febrile?
4. Has the subject administered the following treatments for Inflammatory Bowel Disease?
a)steroids or any topical treatments (enemas) within the last 4 weeks prior to baseline
b)immmunosuppressants, immunomodulators or antimetabolites within the 6 weeks prior to this visit
c)antibiotic use within 7 days of this visit
d)chronic use of any anti-inflammatory drugs (except aminosalicylates) within 7 days of this visit
5. Does the subject have a history of illicit drug abuse or positive urine screen for drugs of abuse or history of alcohol abuse acknowledged during the screening interview and/or noted in the subjects medical history at screening?
6. Has the subject tested positive during a blood screen for Human Immuno- Deficiency Virus (HIV), Hepatitis B surface antigen (HBsAg) or Hepatitis C infection?
7. Does the subject have evidence of infectious colitis, e.g., Clostridium difficile, Amoebiasis, Giardia lamblia, in the stool examination?
8. Does the subject have evidence of gastrointestinal parasites as per stool, ova and parasites testing at screening?
9. Does the subject have evidence of tuberculosis by whole-blood interferon-release assay?
10. Does the subject have any uncontrolled intercurrent illness (e.g., active infection)?
11. Does the subject have a history of gastrointestinal cancer?
12. Has the subject undergone abdominal surgery or any major surgery in the 28 days prior to this visit?
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to access the safety and tolerability of 6 weeks treatment with ORE1001 in patients with mild to moderate ulcerative colitis, as measured by the frequency and severity of adverse events.Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Change in Modified baron Score from BaselineTimepoint: 12 weeks;Change in partial Mayoscore from BaselineTimepoint: 12 weeks;Change in True-Love Witts Score from BaselineTimepoint: 12 weeks;change in UCCS score from baselineTimepoint: 12 weeks;Clinical Remission at week 6Timepoint: week 6;Histological Appearance of the rectum as determined by the acute subscale of the riley scoreTimepoint: 4 weeks