Study of COLAL-PRED to Treat Moderate to Severe Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by:
Prometheus Laboratories
ClinicalTrials.gov Identifier:
NCT00676832
First received: May 9, 2008
Last updated: September 27, 2010
Last verified: September 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 190
Study Start Date: May 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group 1 Drug: Placebo
Placebo solid capsule dosage form administered orally once daily.
Other Name: prednisolone sodium metasulfobenzoate (PMSBS)
Experimental: Group 2 Drug: COLAL-PRED
The study is a double-blinded and results have not been unblinded. Patients were randomized to one of four doses. A solid capsule dosage form was administered orally once daily at doses of 40 mg, 60 mg, 80 mg, or 120 mg.
Other Name: prednisolone sodium metasulfobenzoate (PMSBS)
Experimental: Group 3 Drug: COLAL-PRED
The study is a double-blinded and results have not been unblinded. Patients were randomized to one of four doses. A solid capsule dosage form was administered orally once daily at doses of 40 mg, 60 mg, 80 mg, or 120 mg.
Other Name: prednisolone sodium metasulfobenzoate (PMSBS)
Experimental: Group 4 Drug: COLAL-PRED
The study is a double-blinded and results have not been unblinded. Patients were randomized to one of four doses. A solid capsule dosage form was administered orally once daily at doses of 40 mg, 60 mg, 80 mg, or 120 mg.
Other Name: prednisolone sodium metasulfobenzoate (PMSBS)
Experimental: Group 5 Drug: COLAL-PRED
The study is a double-blinded and results have not been unblinded. Patients were randomized to one of four doses. A solid capsule dosage form was administered orally once daily at doses of 40 mg, 60 mg, 80 mg, or 120 mg.
Other Name: prednisolone sodium metasulfobenzoate (PMSBS)

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
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: NCT00676832

  Show 89 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: Emil Chuang, Sr. Medical Director, GI Clinical Dev & Med Affairs, Prometheus Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00676832     History of Changes
Other Study ID Numbers: 08CP01
Study First Received: May 9, 2008
Last Updated: September 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Prometheus Laboratories:
colitis
ulcerative
moderate
severe

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 16, 2014