Safety and Activity of ORE1001 in Subjects With Ulcerative Colitis
NCT ID: NCT01039597
Last Updated: 2011-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2009-12-31
2011-06-30
Brief Summary
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Detailed Description
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Eligible subjects will be randomly assigned to either ORE1001 or placebo, respectively. Sigmoidoscopies with biopsies will be performed at the first treatment visit and week 6.
Subjects will be instructed to self-administer the study drug on an outpatient basis and will be scheduled to return for clinical evaluation on weeks 2, 4, 6 and between Weeks 10-12.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active study drug
ORE1001 300 mg oral capsules
ORE1001
Oral capsules containing 300 mg of the active, study drug
Placebo control
300 mg oral capsules containing placebo material
Placebo
placebo capsules
Interventions
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ORE1001
Oral capsules containing 300 mg of the active, study drug
Placebo
placebo capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Baron score greater than or equal to 2 at baseline.
3. Truelove-Witt (modified) score of 14 or less.
4. At least 6 months duration of disease
5. At baseline the subject should have either stable disease or stable disease requiring 5-ASA treatment
6. If on a 5-ASA treatment, subject must have been on stable dose for at least two weeks prior to screening and is expected to continue on that dose until the study is completed
7. Subject has normally functioning major organ systems (aside from gastrointestinal tract) as indicated by medical history, vital signs, physical exam and clinical laboratories (including hematology, coagulation, chemistries and urinalysis).
8. Male or female subjects 18-70 years old
9. Subject has provided voluntary written informed consent to participate in this study.
10. Subject may be of child-bearing potential, but is not pregnant, nursing, or planning a pregnancy for the duration of the study and has a negative pregnancy test prior to enrollment.
11. Subject agrees to use a medically-acceptable form of contraception from screening through 30 days after the final dose of study drug. Female partners of male subjects enrolled into this study are also recommended to use an acceptable method of birth control. Males must agree to not donate sperm during the entire study and for 90 days after the last dose of study drug.
Exclusion Criteria
2. Subject has an ALT or serum creatinine greater than 1.5 times the upper limit of normal range for the reference lab at screening.
3. Subject who, in the opinion of the investigator, is febrile at screening.
4. Subject had used the following treatments for IBD: steroids or any or biologic immunomodulators or any topical treatments (e.g. enemas) within the last 4 weeks prior to baseline, immunosuppressants or antimetabolites within the preceding 6 weeks, antibiotic use within the previous 7 days or chronic use of any anti-inflammatory drugs (except aminosalicylates) within 7 days.
5. History of illicit drug abuse or positive urine screen for drugs of abuse or history of alcohol abuse if acknowledged at the screening visit or noted in the subject's medical record at screening.
6. Subject has a positive blood screen for HIV, Hepatitis B (HBsAg), or Hepatitis C.
7. Subject has evidence of infectious colitis, e.g., Clostridium difficile, Amoebiasis, Giardia lamblia by stool examination of at screening.
8. Subject has evidence for gastrointestinal parasites as per stool ova and parasites testing at screening.
9. Subject has evidence of tuberculosis by blood interferon gamma release assay at screening.
10. Any uncontrolled, intercurrent illness (e.g., active infection).
11. History of gastrointestinal cancer.
12. Abdominal surgery or any major surgery within the preceding 28 days of the screening visit.
18 Years
70 Years
ALL
No
Sponsors
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Ore Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Ore Pharmaceuticals, Inc.
Locations
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Robarts Research Institute
London, Ontario, Canada
Dr, Bhatnagar's Clinic
Ahmedabad, Gujarat, India
Vikram Jyoth Centre for Advanced Gastroenterology
Mysore, Karnataka, India
St. John's Medical College Hospital
Bangalore, Karnatka, India
Gut-n-HEPA Care
Indore, Madhya Pradesh, India
Amol Gastroenterology Hospital
Indore, Madhya Pradesh, India
B.Y.L. Nair Hospital
Bombay, Maharashtra, India
Countries
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Central Contacts
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Facility Contacts
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Margeret K Vandervoort, M.S.
Role: primary
References
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Byrnes JJ, Gross S, Ellard C, Connolly K, Donahue S, Picarella D. Effects of the ACE2 inhibitor GL1001 on acute dextran sodium sulfate-induced colitis in mice. Inflamm Res. 2009 Nov;58(11):819-27. doi: 10.1007/s00011-009-0053-3. Epub 2009 Jun 11.
Other Identifiers
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ORX102
Identifier Type: -
Identifier Source: org_study_id
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