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Study of COLAL-PRED to Treat Moderate to Severe Ulcerative Colitis
This study is currently recruiting participants.
Verified by Prometheus Laboratories, April 2009
First Received: May 9, 2008   Last Updated: April 22, 2009   History of Changes
Sponsored by: Prometheus Laboratories
Information provided by: Prometheus Laboratories
ClinicalTrials.gov Identifier: NCT00676832
  Purpose

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
Colitis, Ulcerative
Drug: Placebo
Drug: COLAL-PRED
Phase II

Genetics Home Reference related topics: Crohn disease
MedlinePlus related topics: Ulcerative Colitis
Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate 16-Methyleneprednisolone Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone
U.S. FDA Resources
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

Further study details as provided by Prometheus Laboratories:

Primary Outcome Measures:
  • The proportion of patients with Complete Response at Week 4 defined as a decrease from baseline in the DAI score by ≥ 30% or ≥ 3 points, and with a decrease in the rectal bleeding subscore of ≥ 1 or an absolute rectal bleeding sub-score of 0 or 1. [ Time Frame: Week 4 of the study or at time of withdrawal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of patients in Clinical Remission defined as a DAI score of ≤ 2 points, with no-individual DAI sub-score > 1 at Week 4. Patients in remission by this definition will have a rectal bleeding DAI sub-score of either 0 or 1. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

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
Group 1: Placebo Comparator Drug: Placebo
Placebo solid capsule dosage form administered orally once daily.
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.
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.
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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females must be of non-childbearing potential evidenced by being surgically sterile, postmenopausal for at least 12 months or be using acceptable contraception methods such as contraceptive pill, or two forms of barrier contraception.
  • Disease Activity Index (DAI) Score of 6-10 (inclusive) at the Baseline Visit.
  • Previous colonoscopic and biopsy diagnosis of ulcerative colitis with negative evaluation of the ileum within 3 years of the screening visit.
  • Endoscopic evidence of moderate or severe mucosal disease as assessed by flexible sigmoidoscopy, with a minimum confirmed diagnosis of moderate ulcerative colitis.
  • The following concomitant prescription medications for ulcerative colitis are permitted if the following conditions are met:

    1. Oral 5-aminosalicylic acid (5-ASA )therapy if the following 2 criteria are met:

      1. Must be on a stable dose 2 weeks prior to baseline
      2. Must maintain the stable dose until treatment end.
    2. Azathioprine or 6-mercaptopurine or methotrexate if the 4 following criteria are met:

      1. On therapy continually for at least 3 months prior to baseline.
      2. And on a stable dose for at least 2 weeks prior to baseline.
      3. And must maintain the stable dose until the end of study drug treatment.

Exclusion Criteria:

  • History of colonic or rectal surgery, excluding hemorrhoidal surgery or an appendectomy.
  • Pregnant or breast-feeding females.
  • Diagnosis of diabetes, heart failure, unstable angina, hepatic cirrhosis, kidney failure, adrenocortical insufficiency, or any other unstable medical condition.
  • Known hypersensitivity to corticosteroids
  • Use of oral 5-aminosalicylic acid (5-ASA) or oral corticosteroids during the immediate screening period.
  • Use of immunosuppressive drugs or antibiotics at any time within four weeks prior to screening.
  • Diagnosis of Crohn's disease; indeterminate colitis; microscopic colitis; ischemic, infectious (e.g., salmonella, shigella, etc.), or amebic colitis; or gonococcal proctitis; Clostridium difficile colitis.
  • History of tuberculosis or HIV
  • Clinically significant abnormal laboratory test results, unless regarded by the Investigator as related to ulcerative colitis
  • History of alcohol or drug abuse
  • Known malignancy or history of malignancy that would reduce life expectancy
  • Recent immunization with live viral vaccines
  • History of or active peptic ulcer disease or gastritis
  • Generalized infections such as systemic fungal or hepatitis B or C
  • History of steroid induced severe hypertension, steroid-induced psychosis, or any other severe steroid-related adverse reaction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676832

Contacts
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

  Show 77 Study Locations
Sponsors and Collaborators
Prometheus Laboratories
Investigators
Principal Investigator: David T. Rubin, M.D. The University of Chicago Hospitals
  More Information

No publications provided

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

Keywords provided by Prometheus Laboratories:
colitis
ulcerative
moderate
severe

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009