Safety and Activity of ORE1001 in Subjects With Ulcerative Colitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Ore Pharmaceuticals, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ore Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01039597
First received: December 23, 2009
Last updated: June 7, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Mild to Moderate Ulcerative Colitis
Drug: ORE1001
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Ore Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in the modified Baron Score from Baseline to Week 6 [ Time Frame: 6 Week ] [ Designated as safety issue: No ]
  • Change in the Ulcerative Colitis Clinical Score from Baseline [ Time Frame: 6 Week ] [ Designated as safety issue: No ]
  • Change in the partial Mayo Score fom baseline [ Time Frame: 6 week ] [ Designated as safety issue: No ]
  • Calprotectin concentrations [ Time Frame: 6 week ] [ Designated as safety issue: No ]
  • Riley Acute Inflammation Scale (histology) [ Time Frame: 6 week ] [ Designated as safety issue: No ]
  • Clinical remission [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2009
Estimated Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039597

Contacts
Contact: John F Reinhard, Ph.D. (617) 250-8620 jreinhard@orepharma.com

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

Additional Information:
Publications:
Responsible Party: Senior Vice-President of Clinical Development, Ore Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01039597     History of Changes
Other Study ID Numbers: ORX102
Study First Received: December 23, 2009
Last Updated: June 7, 2011
Health Authority: United States: Food and Drug Administration
India: Ministry of Health
Israel: Ministry of Health
Canada: Health Canada

Keywords provided by Ore Pharmaceuticals, Inc.:
IBD
Ulcerative colitis

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

ClinicalTrials.gov processed this record on August 28, 2014