Combination product: twice daily 90 mg hydrocortisone acetate suppository administered with sephure applicator (DrugBank: Hydrocortisone, Acetate, Hydrocortisone acetate)
1 diseaseID | Disease name (Link within this page) | Number of trials |
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97 | Ulcerative colitis | 1 |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
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1 | NCT04469686 (ClinicalTrials.gov) | July 30, 2020 | 2/7/2020 | Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories | 3-Arm Randomized Placebo Controlled Double Blind Phase 3 Study to Evaluate Safety and Efficacy of Once-Daily and Twice-Daily Hydrocortisone Acetate 90 mg Suppository Administered With a Sephure Applicator in Subjects With Ulcerative Colitis | Ulcerative Proctitis | Combination Product: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator;Combination Product: Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator;Combination Product: Twice daily placebo suppository administered with Sephure applicator | Cristcot LLC | Cristcot HCA LLC | Recruiting | 18 Years | N/A | All | 618 | Phase 3 | United States |