Safety and Activity of ORE1001 in Subjects With Ulcerative Colitis

June 7, 2011 updated by: Ore Pharmaceuticals, Inc.

A Randomized, Double-Blind, Placebo-Controlled Pilot Study of the Safety and Therapeutic Activity of ORE1001 in Subjects With Ulcerative Colitis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a Phase Ib/IIa prospective, multicenter, double blind, randomized, placebo controlled, clinical study to evaluate the safety, tolerability and pilot therapeutic activity of ORE1001, administered as capsules by mouth, for 6 weeks in subjects with Ulcerative Colitis.

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A5K8
        • Recruiting
        • Robarts Research Institute
        • Contact:
          • Margeret K Vandervoort, M.S.
        • Principal Investigator:
          • William Barnett, M.D.
  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 380009
        • Recruiting
        • Dr, Bhatnagar's Clinic
        • Contact:
        • Principal Investigator:
          • Manish Bhatnagar, M.D.
    • Karnataka
      • Mysore, Karnataka, India, 570002
        • Recruiting
        • Vikram Jyoth Centre for Advanced Gastroenterology
        • Contact:
        • Principal Investigator:
          • Rajkumar Wadhwa, M.
    • Karnatka
      • Bangalore, Karnatka, India, 560034
        • Recruiting
        • St. John's Medical College Hospital
        • Contact:
        • Principal Investigator:
          • Harashad Devarbhavi, M.D.
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452001
        • Recruiting
        • Gut-n-HEPA Care
        • Contact:
        • Principal Investigator:
          • Atul Shende, M.D.
      • Indore, Madhya Pradesh, India, 452003
        • Recruiting
        • Amol Gastroenterology Hospital
        • Contact:
        • Principal Investigator:
          • Sulil Jain, M.D.
    • Maharashtra
      • Bombay, Maharashtra, India, 400008
        • Recruiting
        • B.Y.L. Nair Hospital
        • Contact:
        • Principal Investigator:
          • Pravin Rathi, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject has a documented diagnosis of mild to moderate Ulcerative Colitis, as demonstrated clinically and by endoscopy at Visit 2.
  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:

  1. 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.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active study drug
ORE1001 300 mg oral capsules
Drug: ORE1001
Oral capsules containing 300 mg of the active, study drug
Other Names:
  • GL1001
Placebo Comparator: Placebo control
300 mg oral capsules containing placebo material
Drug: Placebo
placebo capsules
Other Names:
  • matched placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The safety and tolerability of ORE1001 in subjects with ulcerative colitis as demonstrated by the frequency and severity of adverse events
Time Frame: 6 Week
6 Week

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the modified Baron Score from Baseline to Week 6
Time Frame: 6 Week
6 Week
Change in the Ulcerative Colitis Clinical Score from Baseline
Time Frame: 6 Week
6 Week
Change in the partial Mayo Score fom baseline
Time Frame: 6 week
6 week
Calprotectin concentrations
Time Frame: 6 week
6 week
Riley Acute Inflammation Scale (histology)
Time Frame: 6 week
6 week
Clinical remission
Time Frame: Week 6
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ore Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

December 23, 2009

First Submitted That Met QC Criteria

December 24, 2009

First Posted (Estimate)

December 25, 2009

Study Record Updates

Last Update Posted (Estimate)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 7, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORX102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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