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临床试验/CTRI/2020/09/028172
CTRI/2020/09/028172招募中3 期

A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum CHS1221

Cristcot HCA LLC0 个研究点目标入组 0 人开始时间: 待定最近更新:
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试验速览

阶段
3 期
状态
招募中
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • •1.Males or non-pregnant, non-lactating females aged 18 years and older.
  • •2. Able to provide a signed informed consent.
  • •3. Confirmed diagnosis of active UC of the rectum, extending no more than 15 cm (5.9 inches)
  • •proximal to the anal verge as assessed by colonoscopy performed at Visit 2. Note: Subjects
  • •may have a history of more extensive UC (e.g., pancolitis), but have active disease only in the
  • •rectum at the time of enrollment.
  • •4. Modified Mayo sub-score for stool frequency of 1-3 at Screening Visit (Visit 1) and Baseline
  • •Visit (Visit 3).
  • •5. Modified Mayo sub-score for rectal bleeding of 0-2 at Screening Visit (Visit 1) and Baseline
  • •Visit (Visit 3).
  • •6. Modified Mayo colonoscopy sub-score of 2-3 at Colonoscopy (Visit 2) as determined by
  • •Central Reading.
  • •7. Modified Mayo Total Score (without physician global assessment) of 3-8.
  • •8. Females of childbearing potential must be either sexually inactive (abstinent) for 21 days prior
  • •to the first dose and willing to be sexually inactive throughout the study or must be using one
  • •of the following acceptable methods of birth control:
  • •a) Surgically sterile (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) for a minimum period of 1 month prior to screening;
  • •b) Intrauterine device in place for at least 1 month prior to screening;
  • •c) Barrier methods (condom, diaphragm) with spermicide for
  • •at least 21 days prior to screening and willing to continue throughout the study; or
  • •d) Hormonal contraceptives for at least 6 weeks prior to screening.
  • •9. Postmenopausal females with amenorrhea for at least 12 months prior to screening.
  • •10. Subjects willing to abstain from receiving anal sex, anal bleaching, anal waxing, etc.
  • •11. Availability of all the screening assessment results, such as: serum pregnancy test (for females of childbearing potential), medical history, concomitant medication, AEs, vital signs, physical examination, electrocardiogram (ECG), documented colonoscopy assessment, complete blood count, clinical chemistry and serology, urinalysis and stool test
  • •12. Subjects may be allowed to be re-screened for the study after consultation and approval from
  • •the medical monitor but may be enrolled (randomized) only once.

排除标准

  • •1.No colonic mucosal inflammation (absence of active disease) within 15 cm (5.9 inches) proximal to the
  • •anal verge as assessed using the colonoscopy performed at Colonoscopy Visit (Visit 2).
  • •2.Colonic mucosal inflammation extending beyond 15 cm (5.9 inches) proximal to the anal verge
  • •as assessed using the colonoscopy performed at Colonoscopy Visit (Visit 2).
  • •3.Preliminary endoscopic sub-score of 0 or 1 as assessed by the Investigator using the
  • •colonoscopy performed at Colonoscopy Visit (Visit 2).
  • •4.Endoscopic sub-score of 0 or 1 as assessed by the Central Reading using the colonoscopy
  • •performed at Colonoscopy Visit (Visit 2).
  • •5.History or current diagnosis of bacterial or other infectious colitis, radiation-enteritis and
  • •radiation-proctitis, Crohn’s disease, collagenous colitis and indeterminate colitis.
  • •6.Prior gastrointestinal surgery except appendectomy, cholecystectomy, and hernia.
  • •7.Concomitant active gastrointestinal disease (except Irritable Bowel Syndrome) or distortion of
  • •intestinal anatomy.
  • •8.Bleeding hemorrhoids at the time of enrollment.
  • •9.History of recurrent diverticulitis and/or diverticulitis at the time of enrollment.
  • •10.History of recurrent pancreatic disease.
  • •11.Uncontrolled, previously diagnosed type 1 or 2 diabetes mellitus.
  • •12.Uncontrolled abnormal thyroid function.
  • •13.Mean value for triplicate sitting SBP >160 mm Hg and/or DBP >100 mm Hg after at least a 5-
  • •minute seated rest at the Screening visit. The Investigator or the treating physician is allowed
  • •to adjust background blood pressure medication(s) to lower blood pressure values in order for the subject to be re-assessed for enrollment eligibility.
  • •14. Clinically significant ECG abnormality at screening that requires further diagnostic evaluation or intervention (e.g., new, clinically significant arrhythmia or a conduction disturbance).
  • •15. Serum hemoglobin levels <7.5 g/dL.
  • •16. Indication of impaired liver function as shown by an abnormal liver function profile at Screening (e.g., repeated values of aspartate aminotransferase [AST] and alanine
  • •aminotransferase [ALT] = 2 × the upper limit of normal).
  • •17. History of sclerosing cholangitis, cirrhosis, or hepatic impairment.
  • •18. Renal disease manifested by serum creatinine >2.0 mg/dL.
  • •19. History of avascular necrosis of hip.
  • •20. History or signs/symptoms of or positive test result at screening for cytomegalovirus,
  • •tuberculosis, human immunodeficiency virus, hepatitis B or C infection.
  • •21. History or signs/symptoms of ocular herpes simplex or ocular varicella zoster infection.
  • •22. History of malignant disease, with the exception of basal cell carcinoma; squamous cell carcinoma in situ of the skin; cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to screening.
  • •23. Diagnosis of Addison’s disease, congenital adrenal hyperplasia, or other form of adrenal insufficiency.
  • •24. Subjects with abnormal response to the ACTH stimulation test performed at the screening visit (Visit 1).
  • •25. Active systemic infection.
  • •26. Toxic megacolon, fistula, perforation, or abscess.
  • •27. History of uncontrolled psychiatric disorders o

研究者

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