Trial Outcomes & Findings for Study to Evaluate the Long-Term Safety of PA32540 in Subjects Who Are at Risk for Developing Aspirin-Associated Gastric Ulcers (NCT NCT00995410)

Last Updated: 2016-02-17

Results Overview

Incidence of adverse events and monitoring vital signs and clinical laboratory values. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

380 participants

Primary outcome timeframe

12 months

Results posted on

2016-02-17

Participant Flow

A multi-center US study in which 44 sites recruited subjects between November 2009 and May 2010

Screening for eligibility and wash-out of restricted medications

Participant milestones

Participant milestones
Measure	PA32540 Tablet 325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)
Overall Study STARTED	380
Overall Study Treated	379
Overall Study COMPLETED	292
Overall Study NOT COMPLETED	88

Reasons for withdrawal

Reasons for withdrawal
Measure	PA32540 Tablet 325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)
Overall Study Adverse Event	51
Overall Study Withdrawal by Subject	7
Overall Study Lost to Follow-up	2
Overall Study Misc	28

Baseline Characteristics

Study to Evaluate the Long-Term Safety of PA32540 in Subjects Who Are at Risk for Developing Aspirin-Associated Gastric Ulcers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PA32540 Tablet n=379 Participants 325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	130 Participants n=5 Participants
Age, Categorical >=65 years	249 Participants n=5 Participants
Age, Continuous	67.3 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	113 Participants n=5 Participants
Sex: Female, Male Male	266 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	PA32540 Tablet n=379 Participants 325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)
Number of Subjects Monitored for Long-term Safety of PA32540	379 participants

SECONDARY outcome

Timeframe: 12 months

Population: Overall Safety Population. Events were collected by systematic assessment. One subject reported two adverse events leading to discontinuation from the study. SOC from vocabulary, MedDRA (12.1).

Most Frequent (≥ 1%) Treatment Emergent Adverse Events by System Organ Class leading to Discontinuation

Outcome measures

Outcome measures
Measure	PA32540 Tablet n=52 Number of AEs Leading to Discontinuation 325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)
Most Frequent Treatment Emergent Adverse Events Leading to Study Drug Discontinuation Subjects with any AE Leading to Discontinuation	51 participants
Most Frequent Treatment Emergent Adverse Events Leading to Study Drug Discontinuation Gastrointestinal disorders	15 participants
Most Frequent Treatment Emergent Adverse Events Leading to Study Drug Discontinuation Neoplasms benign, malignant and unspecified	7 participants
Most Frequent Treatment Emergent Adverse Events Leading to Study Drug Discontinuation Cardiac Disorders	6 participants
Most Frequent Treatment Emergent Adverse Events Leading to Study Drug Discontinuation Investigations	6 participants

Adverse Events

PA32540 Tablet

Serious events: 55 serious events

Other events: 280 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PA32540 Tablet n=379 participants at risk 325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)
Cardiac disorders Angina pectoris	1.1% 4/379 • Number of events 5 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Cardiac disorders Angina unstable	0.79% 3/379 • Number of events 3 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Cardiac disorders Coronary artery disease	0.79% 3/379 • Number of events 3 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Cardiac disorders Myocardial infarction	0.79% 3/379 • Number of events 3 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Cardiac disorders Atrial fibrillation	0.53% 2/379 • Number of events 2 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Cardiac disorders Cardiac failure congestive	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Cardiac disorders Myocardial ischaemia	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Cardiac disorders Pericardial effusion	0.26% 1/379 • Number of events 3 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Cardiac disorders Sick sinus syndrome	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Cardiac disorders Sinus tachycardia	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Cardiac disorders Ventricular tachycardia	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.79% 3/379 • Number of events 3 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.79% 3/379 • Number of events 3 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage IV	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Gastrointestinal disorders Colitis ulcerative	0.53% 2/379 • Number of events 2 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Gastrointestinal disorders Diverticulitis	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Gastrointestinal disorders Enteritis	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melaena	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Nervous system disorders Cerebral infarction	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Subdural haematoma	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Nervous system disorders Syncope	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Nervous system disorders Thalmic infarction	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Nervous system disorders Tremor	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
General disorders Non-cardiac chest pain	0.53% 2/379 • Number of events 2 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
General disorders Chest pain	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
General disorders Fatigue	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Infections and infestations Pneumonia	0.53% 2/379 • Number of events 2 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Infections and infestations Appendicitis perforated	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Infections and infestations Lobar pneumonia	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Musculoskeletal and connective tissue disorders Compression fracture	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Vascular disorders Aortic aneurysm rupture	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Vascular disorders Arteriosclerosis	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Vascular disorders Deep vein thrombosis	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Eye disorders Diabetic retinopathy	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Hepatobiliary disorders Cholecystitis	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Immune system disorders Anaphylactic reaction	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Metabolism and nutrition disorders Dehydration	0.26% 1/379 • Number of events 1 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.

Other adverse events

Other adverse events
Measure	PA32540 Tablet n=379 participants at risk 325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)
Infections and infestations Bronchitis	4.2% 16/379 • Number of events 17 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Infections and infestations Upper respiratory tract infection	4.2% 16/379 • Number of events 19 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Infections and infestations Nasopharyngitis	4.0% 15/379 • Number of events 18 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Infections and infestations Sinusitis	3.7% 14/379 • Number of events 15 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Gastrointestinal disorders Diarrhoea	5.3% 20/379 • Number of events 24 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Gastrointestinal disorders Dyspepsia	4.2% 16/379 • Number of events 16 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Gastrointestinal disorders Nausea	4.2% 16/379 • Number of events 20 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Gastrointestinal disorders Constipation	2.9% 11/379 • Number of events 11 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Gastrointestinal disorders Abdominal pain upper	2.4% 9/379 • Number of events 9 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Musculoskeletal and connective tissue disorders Back pain	4.2% 16/379 • Number of events 18 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Musculoskeletal and connective tissue disorders Muscle spasms	3.4% 13/379 • Number of events 13 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	3.2% 12/379 • Number of events 13 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	2.4% 9/379 • Number of events 10 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Cough	3.2% 12/379 • Number of events 12 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.6% 6/379 • Number of events 8 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Cardiac disorders Angina pectoris	2.4% 9/379 • Number of events 12 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Nervous system disorders Dizziness	2.9% 11/379 • Number of events 11 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Nervous system disorders Headache	2.9% 11/379 • Number of events 12 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
General disorders Fatigue	2.6% 10/379 • Number of events 10 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
General disorders Oedema peripheral	2.6% 10/379 • Number of events 11 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Investigations Haemoglobin decreased	2.4% 9/379 • Number of events 9 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Vascular disorders Hypertension	2.9% 11/379 • Number of events 11 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Blood and lymphatic system disorders Anaemia	2.6% 10/379 • Number of events 10 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.9% 11/379 • Number of events 14 • Informed consent through 12 months plus 28 days for Serious Adverse Events and Randomization through 12 months for all non-serious adverse events.

Additional Information

John Fort, MD / Chief Medical Officer

POZEN

Phone: 919-913-1030

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Restriction Description: 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