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A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA)

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ClinicalTrials.gov Identifier: NCT01544114
Recruitment Status : Completed
First Posted : March 5, 2012
Results First Posted : October 4, 2017
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Horizon Pharma Ireland, Ltd., Dublin Ireland

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Juvenile Idiopathic Arthritis (JIA)
Interventions: Drug: VIMOVO 250/20
Drug: VIMOVO 375/20
Drug: VIMOVO 500/20

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 51 participants signed informed consent; 5 participants were not assigned to treatment (eligibility criteria not fulfilled).

Reporting Groups
  Description
VIMOVO 250 mg/20 mg 250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
VIMOVO 375 mg/20 mg 375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
VIMOVO 500 mg/20 mg 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months

Participant Flow:   Overall Study
    VIMOVO 250 mg/20 mg   VIMOVO 375 mg/20 mg   VIMOVO 500 mg/20 mg
STARTED   4   20   22 
COMPLETED [1]   3 [1]   16 [1]   17 [1] 
NOT COMPLETED   1   4   5 
Withdrawal by Subject                0                0                3 
Lost to Follow-up                0                2                0 
Adverse Event                1                1                2 
Protocol Violation                0                1                0 
[1] completed study and received 6 months of study drug



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
VIMOVO 250 mg/20 mg 250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
VIMOVO 375 mg/20 mg 375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
VIMOVO 500 mg/20 mg 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
Total Total of all reporting groups

Baseline Measures
   VIMOVO 250 mg/20 mg   VIMOVO 375 mg/20 mg   VIMOVO 500 mg/20 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   20   22   46 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.8  (0.96)   13.6  (1.47)   13.8  (1.33)   13.6  (1.37) 
Age, Customized 
[Units: Participants]
Count of Participants
       
Age Group         
12 years old      2  50.0%      7  35.0%      4  18.2%      13  28.3% 
13 years old      1  25.0%      4  20.0%      7  31.8%      12  26.1% 
14 years old      1  25.0%      2  10.0%      2   9.1%      5  10.9% 
15 years old      0   0.0%      5  25.0%      7  31.8%      12  26.1% 
16 years old      0   0.0%      2  10.0%      2   9.1%      4   8.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      3  75.0%      15  75.0%      15  68.2%      33  71.7% 
Male      1  25.0%      5  25.0%      7  31.8%      13  28.3% 


  Outcome Measures

1.  Primary:   Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug   [ Time Frame: SAEs were collected from signing of informed consent through Month 6 (or end of treatment) plus 14 days. AEs were collected from administration of VIMOVO through Month 6 (or end of treatment) plus 14 days. ]

2.  Secondary:   Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t])   [ Time Frame: pre-dose, and up to 3 hours post-dose ]

3.  Secondary:   PK of Esomeprazole: Oral Plasma Clearance (CL/F)   [ Time Frame: pre-dose, and up to 3 hours post-dose ]

4.  Secondary:   PK of Esomeprazole: Absorption Rate Constant (Ka)   [ Time Frame: pre-dose, and up to 3 hours post-dose ]

5.  Secondary:   PK of Esomeprazole: Oral Volume of Distribution (V/F)   [ Time Frame: pre-dose, and up to 3 hours post-dose ]

6.  Secondary:   PK of Naproxen: Trough Plasma Concentrations   [ Time Frame: Month 1 and Month 3: pre-dose, and up to 3 hours post-dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Julie Ball, Executive Director of Clinical Development & Operations
Organization: Horizon Pharma, Inc.
e-mail: clinicaltrials@horizonpharma.com



Responsible Party: Horizon Pharma Ireland, Ltd., Dublin Ireland
ClinicalTrials.gov Identifier: NCT01544114     History of Changes
Other Study ID Numbers: D1120C00037
First Submitted: February 21, 2012
First Posted: March 5, 2012
Results First Submitted: August 4, 2017
Results First Posted: October 4, 2017
Last Update Posted: October 4, 2017