Study to Evaluate Efficacy and Safety of PENNEL Capsule in the Patients With Chronic Liver Disease

This study has been completed.
Sponsor:
Information provided by:
PharmaKing
ClinicalTrials.gov Identifier:
NCT01393678
First received: July 3, 2011
Last updated: July 12, 2011
Last verified: July 2011
  Purpose

The drug in this study is combined product of biphenyl dimethyl dicarboxylate (DDB) and garlic oil. This components showed synergistic enhancing effects in previous tests. In phase 2 test, 6 cap three times a day dosage (2cap T.I.D) is better than other dosage. Based on above, this study is phase 3 test to prove efficacy and safety of PENNEL.


Condition Intervention Phase
Chronic Liver Disease
Drug: NISSEL
Drug: PENNEL
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, 2 Parallel Group, Phase 3 Study of PENNEL Capsule in Chronic Liver Disease

Resource links provided by NLM:


Further study details as provided by PharmaKing:

Primary Outcome Measures:
  • ALT(Alanine Aminotransferase) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

    To evaluate the efficacy of the PENNEL capsule on change ALT from baseline to 10 weeks (Change from Baseline in Alanine Aminotransferase at 10 weeks)

    The measurements were conducted four times, including ① before administration, ② the 4th week of administration, ③ the 8th week of administration ④ the 10th week of administration



Secondary Outcome Measures:
  • AST (Aspartate Aminotransferase) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

    To evaluate the efficacy of the PENNEL capsule on change AST from baseline to 10 weeks(Change from Baseline in Aspartate Aminotransferase at 10 weeks)

    The measurements were conducted four times, including ① before administration, ② the 4th week of administration, ③ the 8th week of administration ④ the 10th week of administration


  • g-GT (γ-glutamyl transpeptidase) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

    To evaluate the efficacy of the PENNEL capsule on change g-GT from baseline to 10 weeks (Change from Baseline in γ-glutamyl transpeptidase at 10 weeks)

    The measurements were conducted four times, including ① before administration, ② the 4th week of administration, ③ the 8th week of administration ④ the 10th week of administration


  • Total bilirubin [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

    To evaluate the efficacy of the PENNEL capsule on change Total bilirubin from baseline to 10 weeks (Change from Baseline in Total bilirubin at 10 weeks)

    The measurements were conducted four times, including ① before administration, ② the 4th week of administration, ③ the 8th week of administration ④ the 10th week of administration


  • PLT (Platelet) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

    To evaluate the efficacy of the PENNEL capsule on change PLT from baseline to 10 weeks (Change from Baseline in Platelet count at 10 weeks)

    The measurements were conducted four times, including ① before administration, ② the 4th week of administration, ③ the 8th week of administration ④ the 10th week of administration


  • Total cholesterol [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

    To evaluate the efficacy of the Oltipraz on change Total cholesterol from baseline to 10 weeks (Change from Baseline in Total cholesterol at 10 weeks)

    The measurements were conducted four times, including ① before administration, ② the 4th week of administration, ③ the 8th week of administration ④ the 10th week of administration



Enrollment: 220
Study Start Date: November 1997
Study Completion Date: May 1998
Primary Completion Date: March 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PENNEL
2cap T.I.D
Drug: PENNEL
Biphenyl Dimethyl Dicarboxylate 25mg & garlic oil 50mg ............. 1cap
Active Comparator: NISSEL

NISSEL

BDD (biphenylmethyl dicarboxylate) ................25mg

2cap T.I.D

Drug: NISSEL
Biphenyl Dimethyl Dicarboxylate 25mg ............. 1 cap

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with chronic hepatitis by biopsy
  • Patients over 20, under 65 years of age.
  • Patients with abnormal transaminase value.

Exclusion Criteria:

  • Pregnant and lactating women.
  • Patients who have any history of esophageal bleeding, hepatic encephalopathy, ascites.
  • Diabetes, thyroid dysfunction, fatty liver, liver cancer patients.
  • Toxic hepatitis, alcoholic hepatitis.
  • Total bilirubin value more than 3.0 mg/dl.
  • Albumin value less than 3.0 g/dl.
  • Patients who participating in other study about drug.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393678

Locations
Korea, Republic of
Hanyang University Hospital
Seoul, Seongdong-gu,, Korea, Republic of
Sponsors and Collaborators
PharmaKing
Investigators
Principal Investigator: Minho Lee, MD.PhD Hanyang University
  More Information

No publications provided

Responsible Party: R&D department, CR team
ClinicalTrials.gov Identifier: NCT01393678     History of Changes
Other Study ID Numbers: PMK-PENNEL 3
Study First Received: July 3, 2011
Last Updated: July 12, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
7,7'-dimethoxy-(4,4'-bi-1,3-benzodioxole)-5,5'-dicarboxylic acid dimethyl ester
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014