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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 (ECLIPSEIV)

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ClinicalTrials.gov Identifier: NCT02189252
Recruitment Status : Completed
First Posted : July 14, 2014
Results First Posted : June 20, 2016
Last Update Posted : June 20, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE June 23, 2014
First Posted Date  ICMJE July 14, 2014
Results First Submitted Date  ICMJE March 29, 2016
Results First Posted Date  ICMJE June 20, 2016
Last Update Posted Date June 20, 2016
Study Start Date  ICMJE October 2014
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA [ Time Frame: 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. ]
    AUC0-24: Area under the plasma concentration versus time curve, from time 0 to 24 hours after start of the meal
  • Baseline-adjusted Cmax for Plasma Total EPA + Total DHA [ Time Frame: 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. ]
    Cmax: Maximum measured plasma concentration over the time span specified
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
the plasma concentration vs. time curve (AUC0-τ) [ Time Frame: 0 to 24 hours (AUC0-24) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • Baseline-adjusted AUC0-24 for Plasma Total EPA [ Time Frame: 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. ]
  • Baseline-adjusted Cmax for Plasma Total EPA [ Time Frame: 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. ]
  • Baseline-adjusted AUC0-24 for Plasma Total DHA [ Time Frame: 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. ]
  • Baseline-adjusted Cmax for Plasma Total DHA [ Time Frame: 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. ]
  • Baseline-adjusted AUC0-24 for Plasma Total DPA [ Time Frame: 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. ]
  • Baseline-adjusted Cmax for Plasma Total DPA [ Time Frame: 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. ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE A Randomized, 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
Brief Summary This is a randomized, open-label crossover study. The primary objective of this study is to compare the relative bioavailability of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), and the ethyl esters of EPA and DHA in plasma from a single 2 g or 4 g dose of Epanova® or 4 g Lovaza®.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Severe Hypertriglyceridemia
Intervention  ICMJE
  • Drug: Epanova
  • Drug: Lovaza
Study Arms  ICMJE
  • Active Comparator: E4:L4
    Crossover Sequence
    Interventions:
    • Drug: Epanova
    • Drug: Lovaza
  • Active Comparator: L4:E4
    Crossover Sequence
    Interventions:
    • Drug: Epanova
    • Drug: Lovaza
  • Active Comparator: E2:L4
    Crossover Sequence
    Interventions:
    • Drug: Epanova
    • Drug: Lovaza
  • Active Comparator: L4:E2
    Crossover Sequence
    Interventions:
    • Drug: Epanova
    • Drug: Lovaza
Publications * Dunbar RL, Gaudet D, Davidson M, Rensfeldt M, Yang H, Nilsson C, Kvarnström M, Oscarsson J. Omega-3 fatty acid exposure with a low-fat diet in patients with past hypertriglyceridemia-induced acute pancreatitis; an exploratory, randomized, open-label crossover study. Lipids Health Dis. 2020 May 30;19(1):117. doi: 10.1186/s12944-020-01295-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2015)
30
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2014)
24
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female, ≥18 years of age;
  2. History of serum TG concentration ≥500 mg/dL within the past 5 years;
  3. Have at least one episode of documented hospitalization for pancreatitis due to hypertriglyceridemia in his/her lifetime;
  4. Have no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of physical examination, ECG, medical history, and routine laboratory test results;
  5. Willing to maintain his/her current activity level and to follow either the NCEP TLC diet with a caloric target for weight maintenance or a prescribed low-fat diet during the screening, treatment, and washout periods (Visits 1 through 6b; Weeks -4 through 12);
  6. Willing to eat the standardized breakfast, lunch, and dinner meals and snacks before and during Visits 4b and 6b (Weeks 4 and 12);
  7. Willing to abstain from alcohol consumption and avoid vigorous physical activity for 48 hours prior to Visits 3 through 6b (Weeks 0 through 12); and
  8. Subject understands the study procedures and is willing and able to sign the informed consent form to participate in the study and the Health Insurance Portability and Accountability Act authorization for release of relevant protected health information to the Investigators and study personnel.

Exclusion Criteria:

  1. An allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, fish, or any of the components of the standardized breakfast, lunch, or dinner meals or snacks (as described to them by study staff)
  2. Poorly controlled hypertension (resting blood pressure ≥160 mmHg systolic and/or ≥100 mmHg diastolic) prior to randomization (Visit 3 [Week 0])
  3. A history of cancer (other than basal cell carcinoma) in the last 2 years
  4. A recent cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient ischemic attack, unstable congestive heart failure requiring a change in treatment), aortic aneurysm or resection, carotid endarterectomy, or revascularization procedure within the 6 months prior to Visit 1
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02189252
Other Study ID Numbers  ICMJE D5880C00003
OM-EPA-013 ( Other Identifier: Omthera )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrea L Lawless, MD Biofortis, Inc Addison IL 60101
PRS Account AstraZeneca
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP