A Randomized-Withdrawal Phase 3 Study Evaluation the Safety and Efficacy of Oral Nalfurafine HCl (AC-820)in Subjects on Hemodialysis With Uremic Pruritus (Renal Itch) (AC120-8231)

NCT00793156 Phase 3 UNKNOWN

Primary objective of this multicenter, double-blind, placebo controlled, randomized withdrawal study are to determine the effectiveness and safety of orally administered AC-820 in doses of 2.5 µg and 5.0 µg daily in patients with moderate to severe itching associated with end-stage renal disease and hemodialysis, and perform a population PK analysis.

Details

Lead sponsor	Acologix, Inc.
Phase	Phase 3
Status	UNKNOWN
Enrolment	350
Start date	2009-12
Completion	2011-03

Conditions

• Uremic Pruritus

Interventions

• Nalfurafine HCl 2.5 µg
• Nalfurafine HCl 5.0 µg
• Placebo

Primary outcomes

• Primary efficacy endpoint is the change in worst itching intensity from baseline, compared to that in the last two weeks of the double blind, placebo controlled, randomized withdrawal period. — 11 weeks