This site is intended for healthcare professionals
  • Home
  • /
  • Clinical trials
  • /
  • Uncategorised Disease
  • /
  • Study of Nalbuphine HCl ER Tablets in Hemodialysis...
Clinical trial

Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus

Read time: 1 mins
Last updated:1st Jun 2014

The primary objectives of the study to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in hemodialysis patients with moderate to severe uremic pruritus and to evaluate the safety and tolerability in the study population.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
Estimated Enrollment: 360
Study Start Date: June 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
nalbuphine HCl ER 60mg
- Experimental: nalbuphine HCl ER 120mg
- Placebo Comparator: Sugar pill

Category Value
Study start date 2014-06-01

View full details