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This is a Phase 3, randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of budesonide foam in subjects with active mild to moderate proctitis or proctosigmoiditis. |
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Adult patients that have had at least one episode of a diverticulitus attack in the last 36 months will be placed on a drug that may help patient symptoms.
The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis |
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This study consists of 2 parts. A multi-center, short-term, double-blind, randomized, parallel group
study (Part 1), and a long-term, double-blind, maintenance study (Part 2) in pediatric subjects 1 to
11 years of age with endoscopically proven GERD. In Part 1, the study will consist of 3 phases: a
14-day screening phase, a double-blind treatment phase of 12 weeks, and an end-of-study or early
withdrawal phase followed by Part 2, which consists a of double-blind treatment continuation for
subjects who achieved healing
(grade 0 on the Hetzel and Dent classification or grade 0 on the
Histological Features of Reflux Esophagitis scale) during the short-term double-blind treatment phase
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This is placebo-controlled study of three rifaximin doses in patients with DIBS. Subjects will be randomized to receive daily doses of placebo BID, rifaximin 275 mg BID, rifaximin 550 mg BID, or 1100 mg BID for 14 days. These four groups will subsequently receive an additional two weeks of placebo for a total of 4 weeks of treatment. A fifth group of subjects will receive rifaximin 550 mg BID for a period of 28 days. Subjects who successfully respond to treatment at the end of the 28-day Treatment Phase will be followed in a Post-treatment Phase that includes study visits during Weeks 6, 8, 12 and 16. Subjects who relapse during the Post-treatment Phase will be discontinued from the study.
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- The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of certolizumab pegol treatment in pediatric patients, aged 6 to 17, with moderately to severe active Crohn's disease. The target enrollment is 160 patients.
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- The purpose of the study is to access the effectiveness and safety of oral rabeprazole in the treatment of acid-related disorders in pediatric patients, focusing specifically on the manifestation of GERD (symptomatic and erosive types).
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- Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
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- The purpose of the study is to evaluate the pharmacokinetics, pharmacodynamics and safety of rabeprazole after single and multiple daily administration in infants between the ages of 1 and 11 months, inclusive, with GERD.
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- Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806
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- Double-blind, randomized, multicenter, placebo-controlled study The purpose of this study is to evaluate the efficacy and safety of HMPL-004 in patients with active moderate Crohn's Disease,compared with placebo.
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