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Your journey
1What's a trial
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More info
You can access this
clinical trial
if you have
Adrenal Insufficiency
and you are
over 18
years old
This is an advanced phase trial assessing
the effectiveness of the new treatment before being released on the market.
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The purpose

This is a randomised, controlled, open, two-armed, two-period cross-over, multi-centre phase II/III study to assess the safety, tolerability and pharmacokinetics of once-daily oral modified-release hydrocortisone in comparison to conventional thrice-daily oral hydrocortisone tablets in patients with adrenal insufficiency

Provided treatments

  • Drug: hydrocortisone (modified release), oral tablet 20 and 5 mg
  • Drug: Hydrocortisone, oral tablet, 10 mg
Tris trial is registered with FDA with number: NCT00915343. The sponsor of the trial is Shire and it is looking for 64 volunteers for the current phase.
Official trial title:
A, Randomised, Controlled, Two-armed, Two-period Cross-over, Multi-centre Phase II/III Study to Assess the Safety and Pharmacokinetics of Once-daily Oral Modified-release Hydrocortisone in Patients With Adrenal Insufficiency