Trial Outcomes & Findings for A 12-month, Phase 3, Open-label, Multi-center Study to Evaluate the Long-term Safety of PN400 (VIMOVO) (NCT NCT00527904)

Last Updated: 2010-08-31

Results Overview

Incidence of adverse events and monitoring vital signs, clinical laboratory values, physical exams, ECG. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared. Treatment-emergent AEs were also summarized by maximum severity, by quartile of number of doses taken and by treatment window.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

239 participants

Primary outcome timeframe

12 months

Results posted on

2010-08-31

Participant Flow

Multi-center US study, 58 sites recruited between October 2007 and March 2009

Screening for eligibility and wash-out of restricted medications

Participant milestones

Participant milestones
Measure	PN400 (VIMOVO) PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
Overall Study STARTED	239
Overall Study COMPLETED	143
Overall Study NOT COMPLETED	96

Reasons for withdrawal

Reasons for withdrawal
Measure	PN400 (VIMOVO) PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
Overall Study Adverse Event	45
Overall Study Withdrawal by Subject	21
Overall Study Lost to Follow-up	8
Overall Study misc	22

Baseline Characteristics

A 12-month, Phase 3, Open-label, Multi-center Study to Evaluate the Long-term Safety of PN400 (VIMOVO)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PN400 (VIMOVO) n=239 Participants PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
Age, Categorical <=18 years	0 Participants 0 • n=5 Participants
Age, Categorical Between 18 and 65 years	161 Participants 67.4 • n=5 Participants
Age, Categorical >=65 years	78 Participants 32.6 • n=5 Participants
Age Continuous	60.8 years STANDARD_DEVIATION 8.64 • n=5 Participants
Sex: Female, Male Female	168 Participants n=5 Participants
Sex: Female, Male Male	71 Participants n=5 Participants
Region of Enrollment United States	239 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Approximately 200 subjects were planned, 239 were enrolled and treated and 143 subjects completed the study. All 239 subjects were evaluable for safety.

Outcome measures

Outcome measures
Measure	PN400 (VIMOVO) n=239 Participants PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
Number of Subjects Monitored for Long-term Safety of PN 400	239 participants

Adverse Events

PN400 (VIMOVO)

Serious events: 13 serious events

Other events: 175 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PN400 (VIMOVO) n=239 participants at risk PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
Infections and infestations Pneumonia	0.84% 2/239 • Number of events 2 • Randomization through 1 year
Infections and infestations Necrotizing fasciitis	0.42% 1/239 • Number of events 1 • Randomization through 1 year
Infections and infestations Staphylococcal infection	0.42% 1/239 • Number of events 1 • Randomization through 1 year
Cardiac disorders Atrial fibrillation	0.42% 1/239 • Number of events 1 • Randomization through 1 year
Cardiac disorders Atrioventricular block complete	0.42% 1/239 • Number of events 1 • Randomization through 1 year
Cardiac disorders Coronary artery disease	0.42% 1/239 • Number of events 1 • Randomization through 1 year
Musculoskeletal and connective tissue disorders Back pain	0.42% 1/239 • Number of events 1 • Randomization through 1 year
Musculoskeletal and connective tissue disorders Osteoarthritis	0.42% 1/239 • Number of events 1 • Randomization through 1 year
Nervous system disorders Carotid artery stenosis	0.42% 1/239 • Number of events 1 • Randomization through 1 year
Nervous system disorders Transient ischemic attack	0.42% 1/239 • Number of events 1 • Randomization through 1 year
Gastrointestinal disorders Hematemesis	0.42% 1/239 • Number of events 1 • Randomization through 1 year
General disorders Non-cardiac chest pain	0.42% 1/239 • Number of events 1 • Randomization through 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.42% 1/239 • Number of events 1 • Randomization through 1 year
Psychiatric disorders Confusional state	0.42% 1/239 • Number of events 1 • Randomization through 1 year

Other adverse events

Other adverse events
Measure	PN400 (VIMOVO) n=239 participants at risk PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
Gastrointestinal disorders Dyspepsia	7.9% 19/239 • Number of events 19 • Randomization through 1 year
Gastrointestinal disorders Abdominal pain upper	2.9% 7/239 • Number of events 7 • Randomization through 1 year
Gastrointestinal disorders Constipation	5.9% 14/239 • Number of events 14 • Randomization through 1 year
Musculoskeletal and connective tissue disorders Arthralgia	4.6% 11/239 • Number of events 11 • Randomization through 1 year
Musculoskeletal and connective tissue disorders Back pain	4.2% 10/239 • Number of events 10 • Randomization through 1 year
Musculoskeletal and connective tissue disorders Osteoarthritis	3.8% 9/239 • Number of events 9 • Randomization through 1 year
General disorders Edema peripheral	4.6% 11/239 • Number of events 11 • Randomization through 1 year
Gastrointestinal disorders Nausea	5.0% 12/239 • Number of events 12 • Randomization through 1 year
Gastrointestinal disorders Abdominal pain lower	4.6% 11/239 • Number of events 11 • Randomization through 1 year
Gastrointestinal disorders Diarrhoea	4.6% 11/239 • Number of events 11 • Randomization through 1 year
Gastrointestinal disorders Abdominal distension	2.5% 6/239 • Number of events 6 • Randomization through 1 year
Gastrointestinal disorders Flatulence	2.1% 5/239 • Number of events 5 • Randomization through 1 year
Gastrointestinal disorders Vomiting	2.1% 5/239 • Number of events 5 • Randomization through 1 year
Infections and infestations Upper respiratory tract infection	5.9% 14/239 • Number of events 14 • Randomization through 1 year
Infections and infestations Bronchitis	3.8% 9/239 • Number of events 9 • Randomization through 1 year
Infections and infestations Sinusitis	2.9% 7/239 • Number of events 7 • Randomization through 1 year
Infections and infestations Urinary tract infection	2.5% 6/239 • Number of events 6 • Randomization through 1 year
Infections and infestations Influenza	2.1% 5/239 • Number of events 5 • Randomization through 1 year
Musculoskeletal and connective tissue disorders Pain in extremity	2.1% 5/239 • Number of events 5 • Randomization through 1 year
Nervous system disorders Headache	2.5% 6/239 • Number of events 6 • Randomization through 1 year
Nervous system disorders Dizziness	2.1% 5/239 • Number of events 5 • Randomization through 1 year
Injury, poisoning and procedural complications Contusion	3.3% 8/239 • Number of events 8 • Randomization through 1 year
Respiratory, thoracic and mediastinal disorders Cough	2.5% 6/239 • Number of events 6 • Randomization through 1 year
Vascular disorders Hypertension	3.8% 9/239 • Number of events 9 • Randomization through 1 year

Additional Information

Senior Vice President, Clinical Research

POZEN

Phone: 919-913-1030

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI agrees that the first publication will be a multi-center publication of the study results. Following this multi-center publication, PI can publish, present or use any non-confidential study results following Sponsor review and comment.
Publication restrictions are in place

Restriction type: OTHER