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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) — AC120-8231  

Uremic Pruritus Clinical Trial

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 Itch)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00793156
Study type Interventional
Source Acologix, Inc.
Contact
Status Not yet recruiting
Phase Phase 3
Start date December 2009
Completion date March 2011
View Details
See also
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Completed NCT02143648 - Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus Phase 2/Phase 3
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Completed NCT03758079 - Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus Phase 4
Completed NCT02229929 - Safety and Pharmacokinetics of IV CR845 in Hemodialysis Patients, and Its Efficacy in Patients With Uremic Pruritus Phase 2
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