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Sponsored by: |
Prometheus Laboratories |
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Information provided by: | Prometheus Laboratories |
ClinicalTrials.gov Identifier: | NCT00676832 |
The purpose of this study is to determine whether COLAL-PRED is a safe and effective treatment for patients with moderate to severe ulcerative colitis.
Condition | Intervention | Phase |
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Colitis, Ulcerative |
Drug: Placebo Drug: COLAL-PRED |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of COLAL-PRED in the Treatment of Patients With Moderate to Severe Ulcerative Colitis |
Estimated Enrollment: | 200 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Placebo Comparator |
Drug: Placebo
Placebo solid capsule dosage form administered orally once daily.
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Group 2: Experimental |
Drug: COLAL-PRED
Solid capsule dosage form administered orally once daily at doses of 40 mg, 60 mg, 80 mg, 120 mg.
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Group 3: Experimental |
Drug: COLAL-PRED
Solid capsule dosage form administered orally once daily at doses of 40 mg, 60 mg, 80 mg, 120 mg.
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Group 4: Experimental |
Drug: COLAL-PRED
Solid capsule dosage form administered orally once daily at doses of 40 mg, 60 mg, 80 mg, 120 mg.
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Group 5: Experimental |
Drug: COLAL-PRED
Solid capsule dosage form administered orally once daily at doses of 40 mg, 60 mg, 80 mg, 120 mg.
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This is a multi-center, randomized, double-blind, placebo-controlled, parallel-design, dose-ranging study. Eligible patients with a DAI score of 6 to 10 (inclusive), plus endoscopic evidence of moderate to severe ulcerative colitis as assessed by flexible sigmoidoscopy, unless colonoscopy is clinically indicated, and rectal bleeding will be randomized to placebo or one of four doses of COLAL-PRED (equivalent to 40, 60, 80, or 120 mg of prednisolone).
The effectiveness and safety of COLAL-PRED will be evaluated at baseline, and after 2 weeks and 4 weeks of treatment. Additional follow-up measurements will take place 7 days post cessation of treatment.
The systemic absorption of COLAL-PRED will be determined by measuring blood levels of prednisolone, prednisolone sodium metasulfobenzoate (PMSBS) and metasulfobenzoate at Week 4.
Hypothalamic-pituitary-adrenocortical (HPA) axis response will be monitored by measuring morning serum cortisol levels at Baseline, Week 2, Week 4, and at follow-up visit and cortisol levels following adrenocorticotrophic hormone (ACTH) stimulation testing at Baseline and Week 4.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The following concomitant prescription medications for ulcerative colitis are permitted if the following conditions are met:
Oral 5-aminosalicylic acid (5-ASA )therapy if the following 2 criteria are met:
Azathioprine or 6-mercaptopurine or methotrexate if the 4 following criteria are met:
Exclusion Criteria:
Contact: Glen D. Park, Pharm.D. | 212-681-2100 ext 107 | gpark@targethealth.com |
Contact: Jules T. Mitchel, Ph.D. | 212-681-2100 ext 0 | julesmitchel@targethealth.com |
Principal Investigator: | David T. Rubin, M.D. | The University of Chicago Hospitals |
Responsible Party: | Prometheus Laboratories, Inc. ( Vanessa Ameen, M.D., Senior Director, Clinical Development & Medical Affairs ) |
Study ID Numbers: | 08CP01 |
Study First Received: | May 9, 2008 |
Last Updated: | April 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00676832 History of Changes |
Health Authority: | United States: Food and Drug Administration |
colitis ulcerative moderate severe |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Methylprednisolone Gastrointestinal Diseases Hormone Antagonists Ulcer Colonic Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Inflammatory Bowel Diseases Methylprednisolone acetate Colitis, Ulcerative |
Prednisolone acetate Intestinal Diseases Neuroprotective Agents Hormones Glucocorticoids Digestive System Diseases Prednisolone Peripheral Nervous System Agents Gastroenteritis Colitis Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Gastrointestinal Diseases Methylprednisolone Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Inflammatory Bowel Diseases Antiemetics Prednisolone acetate Neuroprotective Agents Hormones Pathologic Processes Therapeutic Uses Methylprednisolone Hemisuccinate |
Antineoplastic Agents, Hormonal Ulcer Gastrointestinal Agents Methylprednisolone acetate Colitis, Ulcerative Intestinal Diseases Protective Agents Glucocorticoids Pharmacologic Actions Digestive System Diseases Autonomic Agents Prednisolone Peripheral Nervous System Agents Gastroenteritis Central Nervous System Agents |