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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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

Brief Summary: 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.

Detailed Summary:
Sponsor: Acologix, Inc.

Current Primary Outcome: 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. [ Time Frame: 11 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Acologix, Inc.

Dates:
Date Received: November 17, 2008
Date Started: December 2009
Date Completion: March 2011
Last Updated: February 3, 2010
Last Verified: February 2010