CCDH - Research

Ulcerative Colitis

Procter & Gamble is currently conducting a clinical research study for children and adolescents who have mild to moderate Ulcerative Colitis. Ulcerative Colitis (UC) is a disease of the colon (large intestine). In this disease, there is inflammation (redness and swelling) and ulceration (sores) of the innermost lining of the colon. This study will evaluate the process by which the investigational use of a marketed drug (Asacol®) is absorbed, distributed, broken down (metabolized), and eliminated by the body. Another purpose of this study is to look at the safety and tolerability of Asacol® in the pediatric and adolescent population. All participants in this research study will receive active study medication; however, various strengths of the medication will be used.

Length of Participation: This study will last for at least 6 weeks and will require the patient to visit the clinic at least 4 times.

You may be able to participate if you are:
-5 to 17 years of age
-Have mild to moderate Ulcerative Colitis, either newly or previously diagnosed
-Able to swallow tablets
-Weigh between 37 and 198 pounds

If you are interested in participating, and would like more information, please contact:
Mary Dahlberg
Assistant Director of Research
Center for Children’s Digestive Health
847-723-6983

Study Number PG-2007017 (CAMP II): A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol^® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis

Pediatric Crohn's Disease

Children who are 6 years of age to 17 years old and have a diagnosis of crohn's disease for at least 12 weeks that is confirmed by endoscopy or radiologic evaluation. The study is to evaluate the safety and effectiveness of adalimumab.

For further information or participation, please call (708) 216-3268.