Trial Outcomes & Findings for An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis (NCT NCT02189252)
NCT ID: NCT02189252
Last Updated: 2016-06-20
Results Overview
AUC0-24: Area under the plasma concentration versus time curve, from time 0 to 24 hours after start of the meal
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Results posted on
2016-06-20
Participant Flow
The study subjects were recruited at 6 sites. In total, 30 subjects were screened, of which 15 were randomized to 1 of 4 treatment sequences.
No applicable
Participant milestones
| Measure |
Treatment Sequence 1
Epanova 4g per day: Lovaza 4g per day
|
Treatment Sequence 2
Lovaza 4 g per day:Epanova 4 g per day : 4 subjects
|
Treatment Sequence 3
Epanova 2g per day:Lovaza 4g per day:
|
Treatment Sequence 4
Lovaza 4g per day:Epanova 2g per day:
|
|---|---|---|---|---|
|
Period 1 (Visit 4b, Week 4)
STARTED
|
4
|
4
|
3
|
4
|
|
Period 1 (Visit 4b, Week 4)
COMPLETED
|
4
|
2
|
3
|
4
|
|
Period 1 (Visit 4b, Week 4)
NOT COMPLETED
|
0
|
2
|
0
|
0
|
|
Period 2 (Visit6b, Week 12)
STARTED
|
4
|
2
|
3
|
4
|
|
Period 2 (Visit6b, Week 12)
COMPLETED
|
4
|
2
|
3
|
4
|
|
Period 2 (Visit6b, Week 12)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence 1
Epanova 4g per day: Lovaza 4g per day
|
Treatment Sequence 2
Lovaza 4 g per day:Epanova 4 g per day : 4 subjects
|
Treatment Sequence 3
Epanova 2g per day:Lovaza 4g per day:
|
Treatment Sequence 4
Lovaza 4g per day:Epanova 2g per day:
|
|---|---|---|---|---|
|
Period 1 (Visit 4b, Week 4)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Period 1 (Visit 4b, Week 4)
Adverse Event
|
0
|
1
|
0
|
0
|
Baseline Characteristics
An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis
Baseline characteristics by cohort
| Measure |
Treatment Sequence 1
n=4 Participants
Epanova 4 g per day:Lovaza 4 g per day
|
Treatment Sequence 2
n=4 Participants
Lovaza 4 g per day:Epanova 4 g per day : 4 subjects
|
Treatment Sequence 3
n=3 Participants
Epanova 2 g per day:Lovaza 4 g per day
|
Treatment Sequence 4
n=4 Participants
Lovaza 4 g per day:Epanova 2 g per day: 4 subjects
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 6.86 • n=5 Participants
|
46.0 years
STANDARD_DEVIATION 13.09 • n=7 Participants
|
53.0 years
STANDARD_DEVIATION 16.46 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 11.27 • n=4 Participants
|
49.8 years
STANDARD_DEVIATION 11.16 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.Population: PK population
AUC0-24: Area under the plasma concentration versus time curve, from time 0 to 24 hours after start of the meal
Outcome measures
| Measure |
Epanova 2 g
n=6 Participants
Once daily (QD)
|
Epanova 4 g
n=6 Participants
Once daily (QD)
|
Lovaza 4 g
n=12 Participants
Once daily (QD)
|
|---|---|---|---|
|
Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA
|
17000 hr*nmol/mL
Geometric Coefficient of Variation 121.7
|
18000 hr*nmol/mL
Geometric Coefficient of Variation 104.6
|
12500 hr*nmol/mL
Geometric Coefficient of Variation 80.0
|
PRIMARY outcome
Timeframe: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.Population: PK population
Cmax: Maximum measured plasma concentration over the time span specified
Outcome measures
| Measure |
Epanova 2 g
n=6 Participants
Once daily (QD)
|
Epanova 4 g
n=6 Participants
Once daily (QD)
|
Lovaza 4 g
n=12 Participants
Once daily (QD)
|
|---|---|---|---|
|
Baseline-adjusted Cmax for Plasma Total EPA + Total DHA
|
1090 nmol/mL
Geometric Coefficient of Variation 78.6
|
1200 nmol/mL
Geometric Coefficient of Variation 70.2
|
712 nmol/mL
Geometric Coefficient of Variation 76.7
|
SECONDARY outcome
Timeframe: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.Population: PK Population
Outcome measures
| Measure |
Epanova 2 g
n=6 Participants
Once daily (QD)
|
Epanova 4 g
n=6 Participants
Once daily (QD)
|
Lovaza 4 g
n=12 Participants
Once daily (QD)
|
|---|---|---|---|
|
Baseline-adjusted AUC0-24 for Plasma Total EPA
|
3510 hr*ug/mL
Geometric Coefficient of Variation 117.8
|
3930 hr*ug/mL
Geometric Coefficient of Variation 83.0
|
1730 hr*ug/mL
Geometric Coefficient of Variation 78.4
|
SECONDARY outcome
Timeframe: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.Population: PK Population
Outcome measures
| Measure |
Epanova 2 g
n=6 Participants
Once daily (QD)
|
Epanova 4 g
n=6 Participants
Once daily (QD)
|
Lovaza 4 g
n=12 Participants
Once daily (QD)
|
|---|---|---|---|
|
Baseline-adjusted Cmax for Plasma Total EPA
|
221 ug/mL
Geometric Coefficient of Variation 83.0
|
255 ug/mL
Geometric Coefficient of Variation 65.7
|
100 ug/mL
Geometric Coefficient of Variation 74.9
|
SECONDARY outcome
Timeframe: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.Population: PK Population
Outcome measures
| Measure |
Epanova 2 g
n=6 Participants
Once daily (QD)
|
Epanova 4 g
n=6 Participants
Once daily (QD)
|
Lovaza 4 g
n=12 Participants
Once daily (QD)
|
|---|---|---|---|
|
Baseline-adjusted AUC0-24 for Plasma Total DHA
|
1710 hr*ug/mL
Geometric Coefficient of Variation 136.3
|
1550 hr*ug/mL
Geometric Coefficient of Variation 195.2
|
2190 hr*ug/mL
Geometric Coefficient of Variation 86.9
|
SECONDARY outcome
Timeframe: This is a crossover study with two treatment periods. The estimated treatment effects were based on the within-subject comparison between the two treatments, each having a 4-week duration and a 4-week wash off period in between.Population: PK Population
Outcome measures
| Measure |
Epanova 2 g
n=6 Participants
Once daily (QD)
|
Epanova 4 g
n=6 Participants
Once daily (QD)
|
Lovaza 4 g
n=12 Participants
Once daily (QD)
|
|---|---|---|---|
|
Baseline-adjusted Cmax for Plasma Total DHA
|
116 ug/mL
Geometric Coefficient of Variation 76.1
|
118 ug/mL
Geometric Coefficient of Variation 89.2
|
128 ug/mL
Geometric Coefficient of Variation 82.3
|
SECONDARY outcome
Timeframe: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.Population: PK Population
Outcome measures
| Measure |
Epanova 2 g
n=6 Participants
Once daily (QD)
|
Epanova 4 g
n=6 Participants
Once daily (QD)
|
Lovaza 4 g
n=12 Participants
Once daily (QD)
|
|---|---|---|---|
|
Baseline-adjusted AUC0-24 for Plasma Total DPA
|
244 hr*ug/mL
Geometric Coefficient of Variation 225.3
|
380 hr*ug/mL
Geometric Coefficient of Variation 240.9
|
108 hr*ug/mL
Geometric Coefficient of Variation 374.3
|
SECONDARY outcome
Timeframe: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.Population: PK Population
Outcome measures
| Measure |
Epanova 2 g
n=6 Participants
Once daily (QD)
|
Epanova 4 g
n=6 Participants
Once daily (QD)
|
Lovaza 4 g
n=12 Participants
Once daily (QD)
|
|---|---|---|---|
|
Baseline-adjusted Cmax for Plasma Total DPA
|
23.0 ug/mL
Geometric Coefficient of Variation 64.2
|
26.4 ug/mL
Geometric Coefficient of Variation 83.3
|
11.1 ug/mL
Geometric Coefficient of Variation 128.9
|
Adverse Events
Epanova 2 g (I)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Epanova 4 g (I)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Lovaza 4 g (I)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Epanova 2 g (II)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Epanova 4 g (II)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Lovaza 4 g (II)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Epanova 2 g (I)
n=3 participants at risk
Treatment period I
|
Epanova 4 g (I)
n=4 participants at risk
Treatment period I
|
Lovaza 4 g (I)
n=8 participants at risk
Treatment period I
|
Epanova 2 g (II)
n=4 participants at risk
Treatment period II
|
Epanova 4 g (II)
n=2 participants at risk
Treatment period II
|
Lovaza 4 g (II)
n=7 participants at risk
Treatment period II
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Any
|
0.00%
0/3
|
0.00%
0/4
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3
|
0.00%
0/4
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Any
|
66.7%
2/3
|
50.0%
2/4
|
25.0%
2/8
|
50.0%
2/4
|
50.0%
1/2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3
|
25.0%
1/4
|
0.00%
0/8
|
25.0%
1/4
|
50.0%
1/2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3
|
25.0%
1/4
|
12.5%
1/8
|
25.0%
1/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3
|
0.00%
0/4
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/4
|
50.0%
1/2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/7
|
|
General disorders
Any
|
0.00%
0/3
|
25.0%
1/4
|
37.5%
3/8
|
50.0%
2/4
|
0.00%
0/2
|
0.00%
0/7
|
|
General disorders
Local swelling
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
2/8
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/7
|
|
General disorders
Asthenia
|
0.00%
0/3
|
0.00%
0/4
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/7
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
25.0%
1/4
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Infections and infestations
Any
|
33.3%
1/3
|
50.0%
2/4
|
0.00%
0/8
|
25.0%
1/4
|
50.0%
1/2
|
0.00%
0/7
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/3
|
25.0%
1/4
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3
|
25.0%
1/4
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Infections and infestations
Influenza
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/8
|
25.0%
1/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/3
|
25.0%
1/4
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/4
|
50.0%
1/2
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Any
|
0.00%
0/3
|
25.0%
1/4
|
25.0%
2/8
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
|
25.0%
1/4
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/3
|
0.00%
0/4
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3
|
0.00%
0/4
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Nervous system disorders
Any
|
0.00%
0/3
|
25.0%
1/4
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/2
|
14.3%
1/7
|
|
Nervous system disorders
Headache
|
0.00%
0/3
|
25.0%
1/4
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/2
|
14.3%
1/7
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3
|
0.00%
0/4
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Renal and urinary disorders
Any
|
0.00%
0/3
|
0.00%
0/4
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3
|
0.00%
0/4
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Any
|
33.3%
1/3
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3
|
0.00%
0/4
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Any
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/8
|
25.0%
1/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Xanthelasma
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/8
|
25.0%
1/4
|
0.00%
0/2
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Xanthoma
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/8
|
25.0%
1/4
|
0.00%
0/2
|
0.00%
0/7
|
|
General disorders
Fatigue
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
2/8
|
50.0%
2/4
|
0.00%
0/2
|
0.00%
0/7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place