Safety Study of TRK-820 for Patient With Hemodialysis

This study has been completed.
Sponsor:
Collaborator:
Toray Industries, Inc
Information provided by:
SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01248650
First received: November 23, 2010
Last updated: November 24, 2010
Last verified: November 2009

November 23, 2010
November 24, 2010
December 2008
December 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01248650 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Safety Study of TRK-820 for Patient With Hemodialysis
A Clinical Study to Investigate Pharmacokinetics and Safety of Single-Dose TRK-820 Soft Capsule in Patient With Hemodialysis

The purpose of this study is to observe pharmacokinetics and safety of nalfurafine hydrochloride in patients receiving hemodialysis.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Renal Failure
Drug: nalfurafine hydrochloride
  • Active Comparator: TRK-820 5 μg
    Taking TRK-820 5μg(two 2.5μg soft capsules) once on the first day of hospitalization by oral route
    Intervention: Drug: nalfurafine hydrochloride
  • Active Comparator: TRK-820 2.5μg
    Taking TRK-820 2.5μg(one 2.5μg soft capsule) once on the first day of hospitalization by oral route
    Intervention: Drug: nalfurafine hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with chronic renal failure who receive dialysis three times a week on a regular basis and do not expect an important change in treatment nor a rapid change in conditions
  • Patients aged 20 years or older
  • Patients whose post-dialysis BMI measured at the nearest time before the singing day is in the range of 70 ~ 130 %
  • Patients who can understand and follow instructions and participate in the study during the entire study period
  • Patients who signed the informed consent form before participating in the study

Exclusion Criteria:

  • Patients who have confirmed malignant tumor
  • Patients with cognitive impairment including depression, schizophrenia and dementia
  • Patients with hepatic cirrhosis as a complication
  • Patients with drug allergy to opioids
  • Patients with drug dependency or allergic disease (including skin response to UV radiation)
  • Patients who participated in other study and received the investigational drug within 1 month before the signing day
  • Patients who participated in other TRK-820 study within 4 weeks before the signing day
  • Pregnant or lactating women or premenopausal women of childbearing potential who do not conduct contraception
  • Patients who received any of the following drugs within 2 weeks before Day 1

    1. Azole antifungal agents

      1. Ketoconazole
      2. Fluconazole
      3. Itraconazole
      4. Clotrimazole
    2. Macrolide antibiotics

      1. Erythromycin
      2. Midecamycin
      3. Josamycin
      4. Roxithromycin
      5. Clarithromycin
      6. Triacetyloleandomycin
    3. Ritonavir
    4. Cyclosporine
    5. Nifedipine
    6. Cimetidine
    7. Amiodarone
  • Patients who had the following drinks and foods within 2 weeks before Day 1

    1. Foods and drinks containing grape fruit juice
    2. Food and drinks containing St. John's wort
  • Patients who participated in other clinical study during the period between the singing day and hospitalization (Day 1)
  • Patients who smoked and drank from three months before the signing day
  • Patients who are ineligible for the clinical study for other reasons at the investigator's discretion
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01248650
TRK-820_HD_I_2008
No
Hogan Park, SK Chemicals Co.,Ltd.
SK Chemicals Co.,Ltd.
Toray Industries, Inc
Principal Investigator: Wooseong Huh, MD, PhD Samsung Medical Center
SK Chemicals Co.,Ltd.
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP