Efficacy and Tolerability Study of Natura-Alpha in the Treatment of Patients With Active Ulcerative Colitis
Status:
Unknown status
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
Summary
This study is to evaluate the efficacy and tolerability of multiple oral doses of
Natura-alpha capsule administered to patients with active ulcerative colitis. This will be a
randomized, double-blind, placebo-controlled, parallel-design study. Up to 75 patients will
complete this study (20 to 25 patients per treatment group) at approximately 10-12 clinical
sites in the Unites States. Patients will be assigned at a 1:1:1 ratio to receive placebo,
Natura-alpha 10 mg or Natura-alpha 20 mg, b.i.d. Replacement patients may be added, pending
Sponsor approval, if it appears that less than 60 patients will complete the study.