Trial Outcomes & Findings for Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH) (NCT NCT00845845)

NCT ID: NCT00845845

Last Updated: 2013-07-24

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2013-07-24

Participant Flow

Twelve (12) individuals consented and were screened and nine (9) were randomized between March 2006 and June 2009. Due to low enrollment, the study was terminated in October 2010. Participants were recruited by study staff at outpatient clinics at The University of Illinois Chicago Hospitals and Clinics (UIHC).

A screening evaluation was used prior to group assignment to evaluate whether patients were affected by nonalcoholic steatohepatitis (NASH) and to evaluate the inclusion and exclusion criteria.

Participant milestones

Measure	Omega-3-acid Ethyl Esters (Lovaza) Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks	Placebo Participants receive daily placebo and dietary counseling for 24 weeks
Overall Study STARTED	3	6
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Measure	Omega-3-acid Ethyl Esters (Lovaza) Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks	Placebo Participants receive daily placebo and dietary counseling for 24 weeks
Overall Study Lost to Follow-up	0	4

Baseline Characteristics

Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH)

Baseline characteristics by cohort

Measure	Omega-3-acid Ethyl Esters (Lovaza) n=3 Participants Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks	Placebo n=6 Participants Participants receive daily placebo and dietary counseling for 24 weeks	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	6 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: This study was terminated on October 12, 2010 due to low enrollment. Primary analyses were never completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Population: This study was terminated on October 12, 2010 due to low enrollment. Primary analyses were never completed.

Outcome measures

Outcome data not reported

Adverse Events

Omega-3-acid Ethyl Esters (Lovaza)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Omega-3-acid Ethyl Esters (Lovaza) n=3 participants at risk Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks	Placebo n=6 participants at risk Participants receive daily placebo and dietary counseling for 24 weeks
Infections and infestations Herpes zoster	33.3% 1/3 • Number of events 1 • Adverse events were captured using a systematic assessment from baseline (week 0) through week 24 for both the treatment and placebo groups.	0.00% 0/6 • Adverse events were captured using a systematic assessment from baseline (week 0) through week 24 for both the treatment and placebo groups.

Other adverse events

Measure	Omega-3-acid Ethyl Esters (Lovaza) n=3 participants at risk Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks	Placebo n=6 participants at risk Participants receive daily placebo and dietary counseling for 24 weeks
Gastrointestinal disorders Diarrhea	66.7% 2/3 • Number of events 2 • Adverse events were captured using a systematic assessment from baseline (week 0) through week 24 for both the treatment and placebo groups.	0.00% 0/6 • Adverse events were captured using a systematic assessment from baseline (week 0) through week 24 for both the treatment and placebo groups.

Additional Information

Scott Cotler, M.D. Professor of Medicine

The University of Illinois Chicago

Phone: 708-216-3789

Email: scotler@lumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place