CLINICAL TRIAL NO: EU820UPV01 A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TRK-820 IN HEMODIALYSIS PATIENTS WITH UREMIC PRURITUS EudraCT No: 2005-003469-18 Short Title: TRK-820 UP 5...

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Reference: EUCTR2005-003469-18

CLINICAL TRIAL NO: EU820UPV01 A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TRK-820 IN HEMODIALYSIS PATIENTS WITH UREMIC PRURITUS EudraCT No: 2005-003469-18 Short Title: TRK-820 UP 5µg

Woman and Man

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Extract

To compare the efficacy of three times a week i.v. treatment with TRK-820 5µg versus placebo in hemodialysis patients with UP following completion of a four-week parallel-group treatment period. Previously conducted Phase III studies showed a trend towards statistically significant results on efficacy for i.v. 5µg TRK-820 three times a week over placebo in a parallel group study with four weeks treatment as well as in a cross-over study with treatment periods of two weeks each.


Inclusion criteria

  • Patients on hemodialysis three times a week suffering from Uremic Pruritus (UP), uncontrolled by current medication(s) and/or treatment(s), will be enrolled