Pentoxifylline Versus Pioglitazone In Non-Alcoholic Steatohepatiti (NASH)

This study is currently recruiting participants.

Verified by Govind Ballabh Pant Hospital, May 2008

First Received: May 19, 2008 Last Updated: May 20, 2008 History of Changes

Sponsor:	Govind Ballabh Pant Hospital
Information provided by:	Govind Ballabh Pant Hospital
ClinicalTrials.gov Identifier:	NCT00681733

Purpose

To assess the metabolic factors in lean and obese patients with NASH.
To compare the efficacy of pentoxifylline versus pioglitazone on the metabolic profile and liver histology of NASH patients.

Condition	Intervention
Metabolic Parameters and Liver Histology	Drug: Pioglitazone Drug: Pentoxifylline

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study Of Metabolic Factors And Efficacy Of Pentoxifylline Versus Pioglitazone In Lean And Obese Nash (Non-Alcoholic Steatohepatitis) Patients.

Resource links provided by NLM:

MedlinePlus related topics: Obesity

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Pentoxyl Pentoxifylline

U.S. FDA Resources

Further study details as provided by Govind Ballabh Pant Hospital:

Primary Outcome Measures:

Improvement in metabolic profile and histology [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Side effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Pioglitazone	Drug: Pioglitazone Pentoxifylline 1200mg/day in 3 divided doses. Pioglitazone 30 mg/day in single dose Drug: Pioglitazone 30 mg OD
B: Active Comparator Pentoxifylline	Drug: Pentoxifylline 1200 mg/d

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with biopsy proven NASH will be enrolled. Abdominal USG showing diffusely echogenic liver suggestive of fatty infiltration of liver.
ALT > 1.2 times the upper limit of normal for > 6 months.(atleast three readings one month apart)
Liver Biopsy showing steatosis affecting >10% of hepatocytes with necroinflammatory activity, ballooning hepatocytes &/ or fibrosis.

Exclusion Criteria:

Alcohol intake of more than 20g/wk
Evidence of viral/ autoimmune hepatitis
PBC (Primary biliary cirrhosis)
Biliary obstrution
Wilson disease
Haemchromatosis
Decompensated cirrhosis
Drug ingestion of the follwing drugs for a period of more than 4 weeks during past 6 weeks - Amiodarone, Methotrexate, Perhexiline, Glucocorticoids, Estrogens, Tamoxifen, Nifedipine, Diltiazem, Tamoxifen.
DM Type I

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681733

Contacts

Contact: Barjesh Ch Sharma, MD, DM

91-011-2323-4242 ext 5203

drbcsharma@hotmail.com

Locations

India
Dr. Barjesh Chander Sharma	Recruiting
New Delhi, India, 110001
Contact: Barjesh Ch Sharma, MD, DM 91-011-2323-4242 ext 5203 drbcsharma@hotmail.com
Principal Investigator: Barjesh Ch Sharma, MD, DM

Sponsors and Collaborators

Govind Ballabh Pant Hospital

Investigators

Principal Investigator:

Barjesh Ch Sharma, MD, DM

G B Pant Hospital Hospital, New Delhi

More Information

No publications provided

Responsible Party:	G B Pant Hospital, New Delhi ( Dr. B C Sharma, professor, G B Pant Hospital, New Delhi )
Study ID Numbers:	drakchaudhary, drakchaudhary
Study First Received:	May 19, 2008
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00681733 History of Changes
Health Authority:	India: Ministry of Health

Keywords provided by Govind Ballabh Pant Hospital:

NASH Pentoxifylline Pioglitazone

Additional relevant MeSH terms:

Vasodilator Agents
Liver Diseases
Radiation-Protective Agents
Antioxidants
Pioglitazone
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hematologic Agents
Fatty Liver
Enzyme Inhibitors

Cardiovascular Agents
Protective Agents
Pentoxifylline
Pharmacologic Actions
Hypoglycemic Agents
Digestive System Diseases
Phosphodiesterase Inhibitors
Therapeutic Uses
Free Radical Scavengers
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010