Safety and Efficacy of Roflumilast and Pioglitazone in Treating Adults With Nonalcoholic SteatoHepatitis

Conditions

• Nonalcoholic Steatohapatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Roflumilast — DRUG
  Roflumilast dose
• Pioglitazone — DRUG
  Pioglitazone dose
• Placebo — DRUG
  Pioglitazone placebo-matching dose
• Placebo — DRUG
  Roflumilast placebo-matching dose

Study Details

The purpose of this study is to evaluate the effect of roflumilast and pioglitazone therapy on serum transaminase (ALT) levels in adults with Nonalcoholic SteatoHepatitis.

Key Dates

Start date

Jun 30, 2013

Status verified

Sep 2016

Primary completion

Sep 30, 2014

Completion

Sep 30, 2014

Study Design

Enrollment

20 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Roflumilast + pioglitazone
  Roflumilast dose and pioglitazone dose, orally for up to 4 months
• Experimental: Roflumilast
  Roflumilast dose and pioglitazone matching-placebo dose orally for up to 4 months.
• Experimental: Pioglitazone
  Pioglitazone dose, orally and roflumilast matching-placebo dose, orally for up to 4 months

Primary Outcome Measure

Amount of Serum Alanine Transaminase (ALT) at Baseline [ Time Frame: Baseline ]

Locations (4)