Trial Outcomes & Findings for Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment (NCT NCT00450216)
NCT ID: NCT00450216
Last Updated: 2024-12-16
Results Overview
The primary efficacy endpoint was the number of participants with gastric ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A participant is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
906 participants
Primary outcome timeframe
24 weeks
Results posted on
2024-12-16
Participant Flow
Participant milestones
| Measure |
HZT-501
HZT-501: Ibuprofen 800mg/famotidine 26.6mg tablets t.i.d.
|
Ibuprofen
Ibuprofen 800mg tablets t.i.d.
|
|---|---|---|
|
Overall Study
STARTED
|
607
|
299
|
|
Overall Study
COMPLETED
|
433
|
170
|
|
Overall Study
NOT COMPLETED
|
174
|
129
|
Reasons for withdrawal
| Measure |
HZT-501
HZT-501: Ibuprofen 800mg/famotidine 26.6mg tablets t.i.d.
|
Ibuprofen
Ibuprofen 800mg tablets t.i.d.
|
|---|---|---|
|
Overall Study
Adverse Event
|
38
|
23
|
|
Overall Study
Withdrawal by Subject
|
48
|
26
|
|
Overall Study
Lost to Follow-up
|
16
|
9
|
|
Overall Study
upper gastrointestinal (UGI) ulcer
|
51
|
51
|
|
Overall Study
misc
|
21
|
20
|
Baseline Characteristics
Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment
Baseline characteristics by cohort
| Measure |
HZT-501
n=607 Participants
HZT-501: Ibuprofen 800mg/famotidine 26.6mg
|
Ibuprofen
n=299 Participants
Ibuprofen 800mg
|
Total
n=906 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
500 Participants
n=5 Participants
|
240 Participants
n=7 Participants
|
740 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
107 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
55.6 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
416 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
624 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
191 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
607 participants
n=5 Participants
|
299 participants
n=7 Participants
|
906 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination and at least the Week 8 endoscopic examination. Participants were assigned according to the treatment to which they were randomized; 2:1 randomization, HZT-501:ibuprofen.
The primary efficacy endpoint was the number of participants with gastric ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A participant is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.
Outcome measures
| Measure |
HZT-501
n=550 Participants
HZT-501: Ibuprofen 800mg/famotidine 26.6mg
|
Ibuprofen
n=262 Participants
Ibuprofen 800mg
|
|---|---|---|
|
Number of Participants Who Develop Endoscopically-diagnosed Gastric Ulcers
|
55 participants
Interval 4.4 to 15.3
|
52 participants
Interval 4.4 to 15.3
|
SECONDARY outcome
Timeframe: 24 weeksThe secondary efficacy endpoint was the number of participants with UGI (i.e., gastric and/or duodenal) ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A participant is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.
Outcome measures
| Measure |
HZT-501
n=550 Participants
HZT-501: Ibuprofen 800mg/famotidine 26.6mg
|
Ibuprofen
n=262 Participants
Ibuprofen 800mg
|
|---|---|---|
|
Number of Participants Who Develop Endoscopically-diagnosed Upper Gastrointestinal (UGI) Ulcers During the 24-week Treatment Period.
|
63 participants
Interval 6.1 to 17.6
|
61 participants
Interval 6.1 to 17.6
|
SECONDARY outcome
Timeframe: 24 weeksThe secondary efficacy endpoint was the number of participants with duodenal ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A participant is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.
Outcome measures
| Measure |
HZT-501
n=550 Participants
HZT-501: Ibuprofen 800mg/famotidine 26.6mg
|
Ibuprofen
n=262 Participants
Ibuprofen 800mg
|
|---|---|---|
|
Number of Participants Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period.
|
8 participants
Interval 1.0 to 6.8
|
14 participants
Interval 1.0 to 6.8
|
SECONDARY outcome
Timeframe: 24 weeksThe secondary efficacy endpoint was the number of participants developing a NSAID-associated serious gastrointestinal complication at any time throughout 24 weeks of treatment. A NSAID-associated serious gastrointestinal complication was defined as a perforation of ulcers, gastric outlet obstruction due to ulcers, and/or gastrointestinal bleeding.
Outcome measures
| Measure |
HZT-501
n=550 Participants
HZT-501: Ibuprofen 800mg/famotidine 26.6mg
|
Ibuprofen
n=262 Participants
Ibuprofen 800mg
|
|---|---|---|
|
The Number of Participants Developing Non-steroidal Anti-inflammatory (NSAID)Associated Serious Gastrointestinal Complications (Perforation of Ulcers, Gastric Outlet Obstruction Due to Ulcers, Gastrointestinal Bleeding)
|
3 particpants
|
0 particpants
|
Adverse Events
HZT-501
Serious events: 22 serious events
Other events: 342 other events
Deaths: 0 deaths
Ibuprofen
Serious events: 13 serious events
Other events: 184 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HZT-501
n=607 participants at risk
HZT-501: Ibuprofen 800mg/famotidine 26.6mg
|
Ibuprofen
n=299 participants at risk
Ibuprofen 800mg
|
|---|---|---|
|
Gastrointestinal disorders
abdominal hernia
|
0.16%
1/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.00%
0/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Injury, poisoning and procedural complications
alcohol poisoning
|
0.16%
1/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.00%
0/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
benign neoplasm
|
0.00%
0/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.33%
1/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Psychiatric disorders
bipolar disorder
|
0.00%
0/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.33%
1/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Investigations
blood creatinine increased
|
0.16%
1/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.00%
0/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Infections and infestations
bronchits
|
0.00%
0/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.33%
1/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Renal and urinary disorders
calculus ureteric
|
0.16%
1/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.00%
0/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Cardiac disorders
cardio-respiratory arrest
|
0.00%
0/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.67%
2/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Infections and infestations
cellulits
|
0.33%
2/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.00%
0/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
General disorders
chest pain
|
0.33%
2/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.33%
1/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Hepatobiliary disorders
cholecystitis
|
0.16%
1/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.00%
0/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Cardiac disorders
coronary artery disease
|
0.00%
0/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.33%
1/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Metabolism and nutrition disorders
dehydration
|
0.33%
2/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.00%
0/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Psychiatric disorders
depression
|
0.16%
1/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.33%
1/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Injury, poisoning and procedural complications
drug toxicity
|
0.00%
0/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.33%
1/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.16%
1/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.00%
0/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea exertional
|
0.00%
0/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.33%
1/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Blood and lymphatic system disorders
esoinophilia
|
0.00%
0/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.33%
1/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Gastrointestinal disorders
hemorrhoid hemorrhage
|
0.16%
1/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.00%
0/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Gastrointestinal disorders
hemorrhoids
|
0.16%
1/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.00%
0/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Vascular disorders
hypertension
|
0.16%
1/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.00%
0/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Metabolism and nutrition disorders
hypoglycemia
|
0.00%
0/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.33%
1/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Psychiatric disorders
major depression
|
0.16%
1/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.00%
0/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Reproductive system and breast disorders
menorrhagia
|
0.16%
1/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.00%
0/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Nervous system disorders
migraine
|
0.16%
1/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.00%
0/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
General disorders
multi-organ failure
|
0.00%
0/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.33%
1/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Musculoskeletal and connective tissue disorders
myositis
|
0.00%
0/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.33%
1/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
General disorders
non-cardiac chest pain
|
0.16%
1/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.00%
0/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
0.00%
0/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.33%
1/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Infections and infestations
pneumonia
|
0.16%
1/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.67%
2/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Renal and urinary disorders
renal failure acute
|
0.49%
3/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.00%
0/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Injury, poisoning and procedural complications
road traffic accident
|
0.00%
0/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.33%
1/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Psychiatric disorders
schizoaffective disorder
|
0.16%
1/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.00%
0/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Nervous system disorders
syncope
|
0.00%
0/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.33%
1/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Injury, poisoning and procedural complications
traumatic brain injury
|
0.33%
2/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.33%
1/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Infections and infestations
upper respiratory tract infection
|
0.00%
0/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.33%
1/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
Other adverse events
| Measure |
HZT-501
n=607 participants at risk
HZT-501: Ibuprofen 800mg/famotidine 26.6mg
|
Ibuprofen
n=299 participants at risk
Ibuprofen 800mg
|
|---|---|---|
|
Gastrointestinal disorders
abdominal distension
|
0.66%
4/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
1.7%
5/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Gastrointestinal disorders
abdominal pain
|
1.3%
8/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
1.3%
4/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Gastrointestinal disorders
abdominal pain upper
|
3.3%
20/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
2.3%
7/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Gastrointestinal disorders
abdominal tenderness
|
0.82%
5/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
1.3%
4/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Blood and lymphatic system disorders
anemia
|
2.1%
13/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.67%
2/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
1.8%
11/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
2.0%
6/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
1.3%
8/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.33%
1/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Investigations
blood pressure increased
|
0.99%
6/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.67%
2/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Infections and infestations
bronchitis
|
2.1%
13/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
1.3%
4/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Gastrointestinal disorders
constipation
|
4.4%
27/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
4.3%
13/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Injury, poisoning and procedural complications
contusion
|
0.33%
2/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
1.3%
4/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
2.0%
12/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
3.0%
9/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Gastrointestinal disorders
diarrhea
|
4.9%
30/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
4.3%
13/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Nervous system disorders
dizziness
|
1.5%
9/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
1.7%
5/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Gastrointestinal disorders
dry mouth
|
0.99%
6/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.67%
2/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Gastrointestinal disorders
dyspepsia
|
5.1%
31/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
7.7%
23/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
General disorders
edema peripheral
|
2.3%
14/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
2.0%
6/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
1.2%
7/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.00%
0/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Injury, poisoning and procedural complications
fall
|
0.82%
5/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
1.3%
4/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
General disorders
fatigue
|
0.33%
2/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
1.3%
4/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Gastrointestinal disorders
flatulence
|
1.3%
8/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.67%
2/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Gastrointestinal disorders
gastritis
|
0.49%
3/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
1.3%
4/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Infections and infestations
gastroenteritis viral
|
1.3%
8/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.33%
1/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
1.6%
10/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
2.7%
8/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Nervous system disorders
headache
|
3.8%
23/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
3.0%
9/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Infections and infestations
herpes zoster
|
0.49%
3/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
1.0%
3/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Vascular disorders
hypertension
|
3.5%
21/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
2.3%
7/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Infections and infestations
influenza
|
1.5%
9/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
2.3%
7/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Psychiatric disorders
insomnia
|
1.2%
7/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.33%
1/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
0.99%
6/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
0.67%
2/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Infections and infestations
nasopharyngitis
|
2.0%
12/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
2.7%
8/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Gastrointestinal disorders
nausea
|
6.6%
40/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
4.3%
13/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
0.16%
1/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
1.0%
3/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
1.2%
7/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
1.0%
3/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Respiratory, thoracic and mediastinal disorders
pharyngolaryngeal pain
|
1.3%
8/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
1.3%
4/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Infections and infestations
pneumonia
|
0.49%
3/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
1.3%
4/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Respiratory, thoracic and mediastinal disorders
sinus congestion
|
0.49%
3/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
1.3%
4/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Infections and infestations
sinusitis
|
2.0%
12/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
3.7%
11/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Gastrointestinal disorders
stomach discomfort
|
2.3%
14/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
1.3%
4/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Nervous system disorders
syncope
|
0.49%
3/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
1.0%
3/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Gastrointestinal disorders
toothache
|
0.49%
3/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
1.0%
3/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Infections and infestations
upper respiratory tract infection
|
3.8%
23/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
3.3%
10/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Infections and infestations
urinary tract infection
|
2.3%
14/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
3.0%
9/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Infections and infestations
viral upper respiratory tract infection
|
0.49%
3/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
1.0%
3/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
|
Gastrointestinal disorders
vomiting
|
2.5%
15/607 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
2.7%
8/299 • Randomization to 28 weeks.
Safety Population: All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination. Participants were assigned to the treatment to which they received; 2:1 randomization, HZT-501:ibuprofen.
|
Additional Information
Amy Grahn, MS Senior Vice President, Clinical Development and Operations
Horizon Pharma, Inc.
Phone: 224-383-3012
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee PI reserves the right to publish or otherwise make public the Study results provided that such communication occurs only after (i) the results of the multicenter Study in its entirety have been publicly disclosed by, or with consent of the sponsor or (ii) 18 months after conclusion of the Study at all sites, whichever comes first. Following this, PI can publish, present or use any non-confidential study results following Sponsor review. PI will not make public raw data or Case Reports.
- Publication restrictions are in place
Restriction type: OTHER