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Not Yet RecruitingPhase 1ACTRN12616000602426

Thioguanine Suppositories For Proctitis

Thioguanine Suppositories For Proctitis. An Open Label Phase I Study To Evaluate the Efficacy and Safety of TG as a suppository

Sponsor

Mater Hospital Brisbane

Enrollment

10 participants

Start Date

Jun 1, 2016

Study Type

Interventional

Conditions

proctitis

Summary

HYPOTHESES: 1. Topical thioguanine (TG) will improve proctitis as demonstrated by a fall in partial Mayo score DESIGN The study will be Phase 1 open label, observational single centre study assessing the efficacy and safety of TG as a suppository.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

  • Patients to include in the study will be screened from:
  • a. Patients attending Gastroenterology outpatient clinics.
  • b. Pre-existing clinical databases in the department of Gastroenterology and Dr Florin’s private rooms at Mater Health Services, South Brisbane.

Exclusion Criteria6

  • a) Able to give informed consent
  • b) Age 18 and above
  • c) Clinical evidence of severe proctitis: Established diagnosis of severe Proctitis (isolated proctitis proven at a colonoscopy within 3 months of consenting and with Mayo endoscopic subscore greater than or equal to 2.)
  • AND
  • d) patients who have failed the ‘standard’ combination of oral and rectal 5-ASA at the time of the consenting process as demonstrated by a partial Mayo Score greater than 3 while on standard treatment.
  • Pregnant women

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Interventions

The overall aim of the current study is to evaluate the safety and efficacy of low dose thioguanine 20mg suppositories in an open-label phase I study involving up to 10 patients with severe proctitis,

The overall aim of the current study is to evaluate the safety and efficacy of low dose thioguanine 20mg suppositories in an open-label phase I study involving up to 10 patients with severe proctitis, who are unresponsive to the current standard of care treatments. Patients will be prescribed one of the below 3 treatments in ascending dose 1. Twice weekly thioguanine rectal suppository 20mg for 28 days (8 supp) 2. 2nd daily thioguanine rectal suppository 20mg for 28 days (14 supp) 3. Daily thioguanine rectal suppository 20mg for 28 days (28 supp) Adherence will be assessed by interview, return of medication and therapeutic drug monitoring

Locations(1)

Mater Adult Hospital - South Brisbane

QLD, Australia

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ACTRN12616000602426