Trials / Completed
CompletedNCT01513161
Efficacy and Safety Study of TRK-820 to Treat Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis
A 14 Day, Multi-center, Randomized, Double Blinded, Placebo-controlled, Parallel Group, Fixed Dose, Phase III Clinical Trial to Assess the Efficacy and Safety of TRK-820 in Treating Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 104 (actual)
- Sponsor
- SK Chemicals Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether nalfurafine hydrochloride is effective and safe in the treatment for conventional-treatment-resistant pruritus in patients receiving hemodialysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | nalfurafine hydrochloride (TRK-820) | Soft capsule containing 2.5ug nalfurafine hydrochloride. Start with 2.5ug of oral administraion once daily, and can be increased up to 5ug if necessary. |
| DRUG | Placebo |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2009-10-01
- Completion
- 2009-10-01
- First posted
- 2012-01-20
- Last updated
- 2012-01-20
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01513161. Inclusion in this directory is not an endorsement.