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Home > "L" Clinical Trials Conditions > Left-Sided Ulcerative Colitis Study  Left-Sided Ulcerative Colitis Study
Left-Sided Ulcerative Colitis Study
For Condition: Ulcerative Colitis
Status: Recruiting
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: To explore the safety of orally delivered rhIL-11 in patients with mild to moderate left-sided ulcerative colitis. To explore the effects of orally administered rhIL-11 on pharmacogenomics in blood samples and in colonic biopsy tissue samples.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - 1. Documented, signed informed consent to participate in this study - 2. Age greater than or equal to 18 years - 3. Documented diagnosis of ulcerative colitis by standard clinical criteria, including endoscopy (either flexible sigmoidoscopy or colonoscopy, sufficient to define the proximal limit of disease) with biopsy - 4. Mild to moderate ulcerative colitis, according to the Physician's Global Assessment of the MUCSS - 5. Hematocrit (HCT) greater than or equal to 30% - 6. Platelet count greater than or equal to 100,000 and less than or equal to 600,000/mm3 - 7. Fibrinogen less than or equal to 600 mg/dL - 8. Baseline values within the following normal laboratory ranges: White blood cell count greater than or equal to 4,000 and less than or equal to 12,000 cells/mL Absolute neutrophil count greater than or equal to 1,500 cells/mL Hemoglobin >10 g per dL Urinalysis, within normal limits - 9. Adequate renal and hepatic function, defined as: Serum creatinine less than or equal to 1.50 x upper limit of normal (ULN) Alanine aminotransferase (ALT, serum glutamic oxaloacetic transaminase (SGPT) less than or equal to 2.0 x ULN Aspartate aminotransferase (AST, SGOT) less than or equal to 2.0 x ULN Total bilirubin less than or equal to 1.25 x ULN Alkaline phosphatase less than or equal to 1.5 x ULN - 10. A negative stool sample must be available prior to randomization for Salmonella, Shigella, Yersinia, and Campylobacter species, Clostridium difficile, parasites, and ova. - 11. Men and women are eligible for this study. Male and female patients who are neither surgically sterile nor postmenopausal must use a medically acceptable form of hormonal or non hormonal birth control during and for 30 days after the study (eg, oral contraceptives, cervical cap, diaphragm, condoms with spermicide, or intrauterine device). - 12. Female patients of childbearing potential (women who are not surgically sterile or postmenopausal) must have a negative serum beta human chorionic gonadotropin (hCG) prior to randomization. - 13. Patients receiving the following medications must fall within the specified stabilization periods for dosing: Azathioprine, 6-MP, or 6-TG for greater than or equal to 12 weeks prior to randomization and have been on stable doses for greater than or equal to 8 weeks before randomization. Oral mesalamine, sulfasalazine, olsalazine, balsalazide or any other 5-ASA compound for greater than or equal to 6 weeks prior to randomization and have been on stable doses for greater than or equal to 2 weeks before randomization. Anti-diarrheal agents (Imodium® when taken as no more than 8 tablets per day; Imodium® AD when taken as no more than either 40 ml or 4 tablets per day; or Lomotil® when taken as no more than 8 tablets per day) for greater than or equal to 1 week prior to randomization Antibiotic therapy (prescribed for ulcerative colitis) for greater than or equal to 2 weeks prior to randomization Exclusion Criteria: - 1. Use of the following medications within the specified time period: Within 48 hours before randomization: NSAIDs (including COX-2 inhibitors and >500 mg/day acetylsalicylic acid) Within 1 week before randomization: 5-ASA (enemas and suppositories) Within 2 weeks before randomization: Mesalamine (topical), Corticosteroids (topical, oral, or parenteral) Within 4 weeks before randomization: Other biological agents, Methotrexate, Tacrolimus (FK506), Cyclosporine A (oral or parenteral), Other investigational drugs Within 4 months before randomization: Monoclonal antibodies to TNF (eg, Remicade®, CDP-571, CDP-870), Enbrel®, Thalidomide - 2. Crohn's disease - 3. Ulcerative proctitis - 4. Ulcerative colitis extending beyond the splenic flexure - 5. Cushing’s Disease - 6. Clinically significant electrocardiogram (ECG) abnormalities - 7. Clinically significant chest X-ray abnormalities - 8. History of angina or cardiac arrhythmia requiring drug or device intervention or other clinically significant heart disease - 9. History of myocardial infarction within the last 12 months - 10. Breastfeeding women - 11. Known human immunodeficiency virus (HIV) infection, symptoms or signs suggestive of HIV infection - 12. Acute systemic infection and/or intestinal infection requiring antibiotic therapy at time of screening - 13. History or evidence of chronic hepatitis B or C viral infection - 14. Decompensated liver disease - 15. History of cancer (other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer) or clinically significant lymphoproliferative disease with less than 5 years documentation of a disease-free state - 16. History of thromboembolic disease (eg, phlebitis, pulmonary embolus) or known congenital or acquired prothrombic disorder (eg, protein C deficiency) - 17. Congestive heart failure or history of congestive heart failure - 18. Bowel obstruction or any condition that may predispose to its development (eg, clinically significant unresolved intestinal stricture, adhesions, or any other condition that would place the patient at risk for developing overt bowel obstruction), intestinal perforation, or significant gastrointestinal hemorrhage - 19. Any other major illness or condition that, in the investigator’s opinion, places the patient at undue risk by participating in the study
Total Enrollment:
Location and Contact Information:
The Cleveland Clinic Foundation *Recruiting*
Cleveland, Ohio, 44195-0001
United States
Recruiting Bret Lashner 216-444-1764
Charlottesville Medical Research *Recruiting*
Charlottesville, Virginia, 22902
United States
Recruiting Daniel Pambianco 804-817-8484
Consultants for Clinical Research *Recruiting*
Cincinnati, Ohio, 45219
United States
Recruiting Michael Safdi 513-751-6667
Summit Research Solutions, PPLC *Recruiting*
Memphis, Tennessee, 38120
United States
Recruiting Lawrence Wruble 901-747-4100
Additional Information:
Study ID Numbers: 3067K5-114-US;
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038922
Other Ulcerative Colitis Studies:
1. Safety and Efficacy of OP2000 (deligoparin) in the Treatment of Active Ulcerative Colitis
2. Left-Sided Ulcerative Colitis Study
3. Research Study in Patients With Severe Ulcerative Colitis
4. Quality of Life in Pediatric Inflammatory Bowel Disease
5. Safety and efficacy of two diffrent doses of Asacol in the treatment of moderately active ulcerative colitis
Related Studies:
Other Ulcerative Colitis Clinical Trials
Other Ohio Clinical Trials
Other Cincinnati Clinical Trials
Left-Sided Ulcerative Colitis Study
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