Chronic Liver DiseasePhase 3NCT01393678
Study to Evaluate Efficacy and Safety of PENNEL Capsule in the Patients With Chronic Liver Disease
A Phase 3 study testing NISSEL and PENNEL in people with Chronic Liver Disease, run by PharmaKing at 1 site in South Korea.
Trial summary
The drug in this study is combined product of biphenyl dimethyl dicarboxylate (DDB) and garlic oil. This components showed synergistic enhancing effects in previous tests. In phase 2 test, 6 cap three times a day dosage (2cap T.I.D) is better than other dosage. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Chronic Liver Disease
- What is being tested?
- NISSEL and PENNEL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 1997to May 1998
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with chronic hepatitis by biopsy
- Patients over 20, under 65 years of age.
- Patients with abnormal transaminase value.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, 2 Parallel Group, Phase 3 Study of PENNEL Capsule in Chronic Liver Disease
The drug in this study is combined product of biphenyl dimethyl dicarboxylate (DDB) and garlic oil. This components showed synergistic enhancing effects in previous tests. In phase 2 test, 6 cap three times a day dosage (2cap T.I.D) is better than other dosage. Based on above, this study is phase 3 test to prove efficacy and safety of PENNEL.
- Conditions
- Chronic Liver Disease
- Being tested
- NISSEL, PENNEL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NISSELDrug
Biphenyl Dimethyl Dicarboxylate 25mg ............. 1 cap
PENNELDrug
Biphenyl Dimethyl Dicarboxylate 25mg \& garlic oil 50mg ............. 1cap
| Study group | Role | What they receive |
|---|---|---|
| PENNEL | Experimental | 2cap T.I.D Receives: Drug: PENNEL |
| NISSEL | Active comparator | NISSEL
BDD (biphenylmethyl dicarboxylate) ................25mg
2cap T.I.D Receives: Drug: NISSEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALT(Alanine Aminotransferase)
To evaluate the efficacy of the PENNEL capsule on change ALT from baseline to 10 weeks (Change from Baseline in Alanine Aminotransferase at 10 weeks)
The measurements were conducted four times, including ① before administration, ② the 4th week of administration, ③ the 8th week of administration ④ the 10th week of administration
Measured: 10 weeks
Secondary outcomes (5)
AST (Aspartate Aminotransferase)
To evaluate the efficacy of the PENNEL capsule on change AST from baseline to 10 weeks(Change from Baseline in Aspartate Aminotransferase at 10 weeks)
The measurements were conducted four times, including ① before administration, ② the 4th week of administration, ③ the 8th week of administration ④ the 10th week of administration
Measured: 10 weeks
g-GT (γ-glutamyl transpeptidase)
To evaluate the efficacy of the PENNEL capsule on change g-GT from baseline to 10 weeks (Change from Baseline in γ-glutamyl transpeptidase at 10 weeks)
The measurements were conducted four times, including ① before administration, ② the 4th week of administration, ③ the 8th week of administration ④ the 10th week of administration
Measured: 10 weeks
Total bilirubin
To evaluate the efficacy of the PENNEL capsule on change Total bilirubin from baseline to 10 weeks (Change from Baseline in Total bilirubin at 10 weeks)
The measurements were conducted four times, including ① before administration, ② the 4th week of administration, ③ the 8th week of administration ④ the 10th week of administration
Measured: 10 weeks
PLT (Platelet)
To evaluate the efficacy of the PENNEL capsule on change PLT from baseline to 10 weeks (Change from Baseline in Platelet count at 10 weeks)
The measurements were conducted four times, including ① before administration, ② the 4th week of administration, ③ the 8th week of administration ④ the 10th week of administration
Measured: 10 weeks
Total cholesterol
To evaluate the efficacy of the Oltipraz on change Total cholesterol from baseline to 10 weeks (Change from Baseline in Total cholesterol at 10 weeks)
The measurements were conducted four times, including ① before administration, ② the 4th week of administration, ③ the 8th week of administration ④ the 10th week of administration
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startNov 1997
- Primary completionMar 1998
- Study completionMay 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaKing
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Minho Lee, MD.PhD, Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393678
- Sponsor's protocol ID
- PMK-PENNEL 3
- Status last verified
- Jul 2011
- First submitted
- 3 Jul 2011
- Last updated
- 13 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, 2 Parallel Group, Phase 3 Study of PENNEL Capsule in Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT01393678
- Acronym / sponsor ID
- PMK-PENNEL 3
- Conditions
- Chronic Liver Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- PharmaKingIndustry (pharma, biotech, devices)
- Study start
- Nov 1997
- Primary completion
- Mar 1998 (actual)
- Study completion
- May 1998 (actual)
- First posted
- 13 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The drug in this study is combined product of biphenyl dimethyl dicarboxylate (DDB) and garlic oil. This components showed synergistic enhancing effects in previous tests. In phase 2 test, 6 cap three times a day dosage (2cap T.I.D) is better than other dosage. Based on above, this study is phase 3 test to prove efficacy and safety of PENNEL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENNEL | Experimental | Drug: PENNEL2cap T.I.D |
| NISSEL | Active comparator | Drug: NISSELNISSEL BDD (biphenylmethyl dicarboxylate) ................25mg 2cap T.I.D |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with chronic hepatitis by biopsy
- Patients over 20, under 65 years of age.
- Patients with abnormal transaminase value.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NISSELBiphenyl Dimethyl Dicarboxylate 25mg ............. 1 cap | Drug | NISSEL |
| PENNELBiphenyl Dimethyl Dicarboxylate 25mg \& garlic oil 50mg ............. 1cap | Drug | PENNEL |
Primary outcome
ALT(Alanine Aminotransferase)
Time frame: 10 weeks
To evaluate the efficacy of the PENNEL capsule on change ALT from baseline to 10 weeks (Change from Baseline in Alanine Aminotransferase at 10 weeks) The measurements were conducted four times, including ① before administration, ② the 4th week of administration, ③ the 8th week of administration ④ the 10th week of administration
5 secondary outcomes
AST (Aspartate Aminotransferase)
Time frame: 10 weeks
g-GT (γ-glutamyl transpeptidase)
Time frame: 10 weeks
Total bilirubin
Time frame: 10 weeks
PLT (Platelet)
Time frame: 10 weeks
Total cholesterol
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2011.
Related trials for Chronic Liver Disease
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
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Liver Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minho Lee, MD.PhD principal investigator
Hanyang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NISSEL and PENNEL in people with Chronic Liver Disease, run by PharmaKing at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALT(Alanine Aminotransferase) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2011.