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

NCT01393665 | Completed Phase 2 DMC

• 1 other identifier: PMK-PENNEL 2
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• AST (Aspartate Aminotransferase)

  6 weeks

• g-GT (γ-glutamyl transpeptidase)

  6 weeks

• Total bilirubin

  6 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

PENNEL capsule

EXPERIMENTAL

1cap or 2cap T.I.D

Drug: PENNEL capsule

Interventions

PENNEL capsule DRUG

hard capsule DDB 25mg \& GO 50mg in cap .......... 1 capsule 1 or 2 capsule, T.I.D

PENNEL capsule

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PharmaKing: lead

Study Sites (2)

Korea Cancer Center Hospital

Seoul, Nowon-gu, 139706, South Korea

Location

Hanyang University Hospital

Seoul, Seongdong-gu, 133792, South Korea

Location

Related Publications (1)

• 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.

  PMID: 22943930 DERIVED

Study Officials

• Minho Lee, MD.PhD

  Hanyang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 3, 2011
• First Posted: July 13, 2011
• Study Start: December 1, 1996
• Primary Completion: May 1, 1997
• Study Completion: October 1, 1997
• Last Updated: July 13, 2011

Record last verified: 2011-07

Locations

KR (2)