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

Chronic Liver Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01393665
• Other study ID #: PMK-PENNEL 2
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2011
• Last updated: July 12, 2011
• Start date: December 1996
• Est. completion date: October 1997

Study information

• Verified date: July 2011
• Source: PharmaKing
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 1997
• Est. primary completion date: May 1997
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Liver Disease
• Liver Diseases

Intervention

Drug:
• PENNEL capsule
hard capsule DDB 25mg & GO 50mg in cap .......... 1 capsule 1 or 2 capsule, T.I.D
• Placebo
Placebo

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Hospital	Seoul	Seongdong-gu
Korea, Republic of	Korea Cancer Center Hospital	Seoul	Nowon-gu

Sponsors (1)

Lead Sponsor	Collaborator
PharmaKing

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ? before administration, ? the 1st week of administration, ? the 3rd week of administration, ? the 6th week of administration, and ? the 1st week after the six-week administration.	6 week	No
Secondary	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 ? before administration, ? the 1st week of administration, ? the 3rd week of administration, ? the 6th week of administration, and ? the 1st week after the six-week administration.	6 weeks	No
Secondary	g-GT (?-glutamyl transpeptidase)	To evaluate the efficacy of the PENNEL capsule on change g-GT from baseline to 6 weeks (Change from Baseline in ?-glutamyl transpeptidase at 6 weeks); The measurements were conducted five times, including ? before administration, ? the 1st week of administration, ? the 3rd week of administration, ? the 6th week of administration, and ? the 1st week after the six-week administration.	6 weeks	No
Secondary	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 ? before administration, ? the 1st week of administration, ? the 3rd week of administration, ? the 6th week of administration, and ? the 1st week after the six-week administration.	6 weeks	No