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Proctitis clinical trials

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NCT ID: NCT01016262 Terminated - Clinical trials for Proctitis, Ulcerative

Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis

Start date: November 30, 2009
Phase: Phase 3
Study type: Interventional

This is a prospective, multicenter, double-blind (DB), controlled, randomized, parallel group comparison Phase 3a study to evaluate the efficacy and safety of new mesalamine suppositories (MAX-002) as compared to placebo and active medicine after 6 weeks of treatment in adults with mild to moderate ulcerative proctitis (UP).

NCT ID: NCT01008423 Completed - Proctitis Clinical Trials

Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis

Start date: November 20, 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who present with a diagnosis of active, mild to moderate, ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible participants will be allowed to maintain previously established oral 5-aminosalicylic acid (5-ASA) treatment at doses up to 4.8 grams/day (g/day).

NCT ID: NCT01008410 Completed - Proctitis Clinical Trials

Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis

Start date: November 17, 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who present with a diagnosis of active, mild to moderate, ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible participants will be allowed to maintain previously established oral 5-aminosalicylic acid (5-ASA) treatment at doses up to 4.8 grams/day (g/day).

NCT ID: NCT00828230 Terminated - Radiation Proctitis Clinical Trials

Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

Start date: September 2008
Phase: Phase 2
Study type: Interventional

To proof the superiority of an 8-week rectal treatment with once-daily 2 mg budesonide versus placebo for the prevention of acute radiation proctitis, and to evaluate the occurrence of chronic radiation proctitis 1 year after start of radiation therapy.

NCT ID: NCT00756197 Withdrawn - Radiation Proctitis Clinical Trials

CryoSpray Ablation(TM)to Determine Safety and Feasibility in Radiation Induced Proctitis

CSALGI2
Start date: October 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the safety, feasibility, tissue response, and subject side effects of liquid nitrogen sprayed through a catheter (CryoSpray AblationTM, "CSA" or "cryospray therapy") via endoscope in subjects with radiation induced proctitis.