Safety and Activity of ORE1001 in Subjects With Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01039597
Recruitment Status : Unknown
Verified June 2011 by Ore Pharmaceuticals, Inc..
Recruitment status was:  Recruiting
First Posted : December 25, 2009
Last Update Posted : June 8, 2011
Information provided by:
Ore Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Mild to Moderate Ulcerative Colitis Drug: ORE1001 Drug: Placebo Phase 1 Phase 2

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Pilot Study of the Safety and Therapeutic Activity of ORE1001 in Subjects With Ulcerative Colitis
Study Start Date : December 2009
Actual Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

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 Name: GL1001

Placebo Comparator: Placebo control
300 mg oral capsules containing placebo material
Drug: Placebo
placebo capsules
Other Name: matched placebo

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change in the modified Baron Score from Baseline to Week 6 [ Time Frame: 6 Week ]
  2. Change in the Ulcerative Colitis Clinical Score from Baseline [ Time Frame: 6 Week ]
  3. Change in the partial Mayo Score fom baseline [ Time Frame: 6 week ]
  4. Calprotectin concentrations [ Time Frame: 6 week ]
  5. Riley Acute Inflammation Scale (histology) [ Time Frame: 6 week ]
  6. Clinical remission [ Time Frame: Week 6 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01039597

Contact: John F Reinhard, Ph.D. (617) 250-8620

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

Additional Information:
Responsible Party: Senior Vice-President of Clinical Development, Ore Pharmaceuticals, Inc. Identifier: NCT01039597     History of Changes
Other Study ID Numbers: ORX102
First Posted: December 25, 2009    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011

Keywords provided by Ore Pharmaceuticals, Inc.:
Ulcerative colitis

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases