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.

Study Overview

• Status: Completed
• Conditions: Chronic Liver Disease
• Intervention / Treatment: Drug: Placebo; Drug: PENNEL capsule

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Nowon-gu
    • Seoul, Nowon-gu, Korea, Republic of, 139706
      • Korea Cancer Center Hospital
  • Seongdong-gu
    • Seoul, Seongdong-gu, Korea, Republic of, 133792
      • Hanyang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ALT (Alanine Aminotransferase)	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.	6 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AST (Aspartate Aminotransferase)	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.	6 weeks
g-GT (γ-glutamyl transpeptidase)	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.	6 weeks
Total bilirubin	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.	6 weeks

Collaborators and Investigators

• Sponsor: PharmaKing

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 1996
• Primary Completion (Actual): May 1, 1997
• Study Completion (Actual): October 1, 1997

Study Registration Dates

• First Submitted: July 3, 2011
• First Submitted That Met QC Criteria: July 12, 2011
• First Posted (Estimate): July 13, 2011

Study Record Updates

• Last Update Posted (Estimate): July 13, 2011
• Last Update Submitted That Met QC Criteria: July 12, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: PMK-PENNEL 2