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

July 3, 2011
July 12, 2011
December 1996
May 1997   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01393665 on ClinicalTrials.gov Archive Site
  • 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.

Same as current
Not Provided
Not Provided
 
Study to Evaluate Efficacy, Safety and Tolerability of PENNEL Capsule in the Patients With Chronic Liver Disease
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Liver Disease
  • Drug: PENNEL capsule

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

    1 or 2 capsule, T.I.D

  • Drug: Placebo
    Placebo
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PENNEL capsule
    1cap or 2cap T.I.D
    Intervention: Drug: PENNEL capsule
Lee MH, Kim YM, Kim SG. Efficacy and tolerability of diphenyl-dimethyl-dicarboxylate plus garlic oil in patients with chronic hepatitis. Int J Clin Pharmacol Ther. 2012 Nov;50(11):778-86. doi: 10.5414/CP201746.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
October 1997
May 1997   (final data collection date for primary outcome measure)

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.
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01393665
PMK-PENNEL 2
Yes
R&D department, CR team
PharmaKing
Not Provided
Principal Investigator: Minho Lee, MD.PhD Hanyang University
PharmaKing
July 2011

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