Safety and Activity of ORE1001 in Subjects With Ulcerative Colitis
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of the Safety and Therapeutic Activity of ORE1001 in Subjects With Ulcerative Colitis
1 other identifier
interventional
50
2 countries
7
Brief Summary
A clinical trial is being conducted to test the effects of a potential new treatment in patients with ulcerative colitis. Study participants will be given capsules containing either ORE1001 or a matching placebo capsule and will take the medicine by mouth for six weeks. Study participants will be asked to visit clinic sites where they will be asked questions about their ulcerative colitis. Small samples of blood will be be drawn at study visits to monitor the participant's health and a tiny sample of tissue will be taken in an endoscopy at two times to determine whether the disease is getting better or worse.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2009
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 23, 2009
CompletedFirst Posted
Study publicly available on registry
December 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 8, 2011
June 1, 2011
1.5 years
December 23, 2009
June 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The safety and tolerability of ORE1001 in subjects with ulcerative colitis as demonstrated by the frequency and severity of adverse events
6 Week
Secondary Outcomes (6)
Change in the modified Baron Score from Baseline to Week 6
6 Week
Change in the Ulcerative Colitis Clinical Score from Baseline
6 Week
Change in the partial Mayo Score fom baseline
6 week
Calprotectin concentrations
6 week
Riley Acute Inflammation Scale (histology)
6 week
- +1 more secondary outcomes
Study Arms (2)
Active study drug
EXPERIMENTALORE1001 300 mg oral capsules
Placebo control
PLACEBO COMPARATOR300 mg oral capsules containing placebo material
Interventions
Eligibility Criteria
You may qualify if:
- Subject has a documented diagnosis of mild to moderate Ulcerative Colitis, as demonstrated clinically and by endoscopy at Visit 2.
- Baron score greater than or equal to 2 at baseline.
- Truelove-Witt (modified) score of 14 or less.
- At least 6 months duration of disease
- At baseline the subject should have either stable disease or stable disease requiring 5-ASA treatment
- 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
- 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).
- Male or female subjects 18-70 years old
- Subject has provided voluntary written informed consent to participate in this study.
- 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.
- 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.
You may not qualify if:
- A clinically significant medical history, medical finding or an ongoing medical or psychiatric condition which, in the opinion of the Investigator, could jeopardize the safety of the subject, impact the validity of the study results, or interfere with the completion of treatment according to this protocol.
- Subject has an ALT or serum creatinine greater than 1.5 times the upper limit of normal range for the reference lab at screening.
- Subject who, in the opinion of the investigator, is febrile at screening.
- 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.
- 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.
- Subject has a positive blood screen for HIV, Hepatitis B (HBsAg), or Hepatitis C.
- Subject has evidence of infectious colitis, e.g., Clostridium difficile, Amoebiasis, Giardia lamblia by stool examination of at screening.
- Subject has evidence for gastrointestinal parasites as per stool ova and parasites testing at screening.
- Subject has evidence of tuberculosis by blood interferon gamma release assay at screening.
- Any uncontrolled, intercurrent illness (e.g., active infection).
- History of gastrointestinal cancer.
- Abdominal surgery or any major surgery within the preceding 28 days of the screening visit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Robarts Research Institute
London, Ontario, N6A5K8, Canada
Dr, Bhatnagar's Clinic
Ahmedabad, Gujarat, 380009, India
Vikram Jyoth Centre for Advanced Gastroenterology
Mysore, Karnataka, 570002, India
St. John's Medical College Hospital
Bangalore, Karnatka, 560034, India
Gut-n-HEPA Care
Indore, Madhya Pradesh, 452001, India
Amol Gastroenterology Hospital
Indore, Madhya Pradesh, 452003, India
B.Y.L. Nair Hospital
Bombay, Maharashtra, 400008, India
Related Publications (1)
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.
PMID: 19517214BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 23, 2009
First Posted
December 25, 2009
Study Start
December 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
June 8, 2011
Record last verified: 2011-06