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

This study has been completed.
Sponsor:
Information provided by:
PharmaKing
ClinicalTrials.gov Identifier:
NCT01393665
First received: July 3, 2011
Last updated: July 12, 2011
Last verified: July 2011
  Purpose

The test agent in this study is a product of biphenylmethyl dicarboxylate (BDD) with garlic oil. The two components were confirmed to have complementary effects because of different operational mechanism in animal experiments, and were examined on humans in this study. Both BDD and garlic oil are expected to show better protection and treatment on hepatotoxicity caused by toxic substances, and the purpose of this study is to confirm efficacy of and safety on human body of the agent and to determine its optimal dose.


Condition Intervention Phase
Chronic Liver Disease
Drug: PENNEL capsule
Drug: Placebo
Phase 2

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: Multicenter, Randomized, Placebo-Controlled, Double-blind Phase 2 Study to Evaluate the Short-term Efficacy, Safety and Tolerance and to Find an Optimal Dosage of the PENNEL Capsule for the Patients With Chronic Liver Disease

Resource links provided by NLM:


Further study details as provided by PharmaKing:

Primary Outcome Measures:
  • ALT (Alanine Aminotransferase) [ Time Frame: 6 week ] [ Designated as safety issue: No ]

    To evaluate the efficacy of the PENNEL capsule on change ALT from baseline to 6 weeks (Change from Baseline in Alanine Aminotransferase at 6 weeks)

    The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.



Secondary Outcome Measures:
  • AST (Aspartate Aminotransferase) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    To evaluate the efficacy of the PENNEL capsule on change AST from baseline to 6 weeks (Change from Baseline in Aspartate Aminotransferase at 6 weeks)

    The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.


  • g-GT (γ-glutamyl transpeptidase) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    To evaluate the efficacy of the PENNEL capsule on change g-GT from baseline to 6 weeks (Change from Baseline in γ-glutamyl transpeptidase at 6 weeks)

    The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.


  • Total bilirubin [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    To evaluate the efficacy of the PENNEL capsule on change Total bilirubin from baseline to 6 weeks (Change from Baseline in Total bilirubin at 6 weeks)

    The measurements were conducted five times, including ① before administration, ② the 1st week of administration, ③ the 3rd week of administration, ④ the 6th week of administration, and ⑤ the 1st week after the six-week administration.



Enrollment: 88
Study Start Date: December 1996
Study Completion Date: October 1997
Primary Completion Date: May 1997 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo
Experimental: PENNEL capsule
1cap or 2cap T.I.D
Drug: PENNEL capsule

hard capsule DDB 25mg & GO 50mg in cap .......... 1 capsule

1 or 2 capsule, T.I.D


  Eligibility

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

Inclusion Criteria:

  • Patients with chronic liver disease.
  • Patients over 20, under 65 years of age.
  • Patients with abnormal transaminase levels.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393665

Locations
Korea, Republic of
Korea Cancer Center Hospital
Seoul, Nowon-gu, Korea, Republic of, 139706
Hanyang University Hospital
Seoul, Seongdong-gu, Korea, Republic of, 133792
Sponsors and Collaborators
PharmaKing
Investigators
Principal Investigator: Minho Lee, MD.PhD Hanyang University
  More Information

No publications provided by PharmaKing

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: R&D department, CR team
ClinicalTrials.gov Identifier: NCT01393665     History of Changes
Other Study ID Numbers: PMK-PENNEL 2
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

ClinicalTrials.gov processed this record on August 19, 2014