Trial Outcomes & Findings for Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216) (NCT NCT00613106)

NCT ID: NCT00613106

Last Updated: 2024-12-17

Results Overview

The objective of this study was to evaluate the long term safety of HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg). No efficacy analyses were planned or performed. Adverse event information was elicited from each participant by indirect questioning using a non-leading question, such as "Has anything bothered you since your last visit or is anything bothering you now?" Adverse event data may also have been volunteered by the participant to the investigator or designee. Physicians assessed the seriousness, severity and causality of each adverse event.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 179 participants
• Primary outcome timeframe: 28 weeks
• Results posted on: 2024-12-17

Participant Flow

Participants that completed the 24-week Treatment Period of Horizon Protocol HZ-CA-301 (NCT00450658) or Horizon Protocol HZ-CA-303 (NCT00460216) without developing an upper gastrointestinal ulcer and who were expected to continue to require daily administration of an NSAID for at least the coming six months were eligible to enroll.

Participants continued to receive treatment with the same double-blind study drug (either HZT 501 [ibuprofen 800 mg/famotidine 26.6 mg] or ibuprofen 800 mg administered TID) they received while participating in Protocol HZ-CA-301 (NCT00450658) or Protocol HZ-CA-303 (NCT00460216).

Participant milestones

Measure	HZT-501 (Ibuprofen/Famotidine) HZT-501: ibuprofen 800mg/famotidine 26.6mg	Ibuprofen Ibuprofen 800mg
Overall Study STARTED	132	47
Overall Study COMPLETED	112	38
Overall Study NOT COMPLETED	20	9

Reasons for withdrawal

Measure	HZT-501 (Ibuprofen/Famotidine) HZT-501: ibuprofen 800mg/famotidine 26.6mg	Ibuprofen Ibuprofen 800mg
Overall Study Adverse Event	3	1
Overall Study Withdrawal by Subject	6	3
Overall Study Lost to Follow-up	7	2
Overall Study misc	4	3

Baseline Characteristics

Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216)

Baseline characteristics by cohort

Measure	HZT-501 (Ibuprofen/Famotidine) n=132 Participants HZT-501: ibuprofen 800mg/famotidine 26.6mg	Ibuprofen n=47 Participants Ibuprofen 800mg	Total n=179 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	110 Participants n=5 Participants	41 Participants n=7 Participants	151 Participants n=5 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants	6 Participants n=7 Participants	28 Participants n=5 Participants
Age, Continuous	55.7 years STANDARD_DEVIATION 9.6 • n=5 Participants	53.6 years STANDARD_DEVIATION 9.3 • n=7 Participants	55.2 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	90 Participants n=5 Participants	32 Participants n=7 Participants	122 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	15 Participants n=7 Participants	57 Participants n=5 Participants
Region of Enrollment United States	132 participants n=5 Participants	47 participants n=7 Participants	179 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 weeks

The objective of this study was to evaluate the long term safety of HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg). No efficacy analyses were planned or performed. Adverse event information was elicited from each participant by indirect questioning using a non-leading question, such as "Has anything bothered you since your last visit or is anything bothering you now?" Adverse event data may also have been volunteered by the participant to the investigator or designee. Physicians assessed the seriousness, severity and causality of each adverse event.

Outcome measures

Measure	HZT-501 (Ibuprofen/Famotidine) n=132 Participants HZT-501: ibuprofen 800mg/famotidine 26.6mg	Ibuprofen n=47 Participants Ibuprofen 800mg
Number of Participants With Treatment Emergent Adverse Events	55 participants	16 participants

Adverse Events

HZT-501 (Ibuprofen/Famotidine)

Serious events: 3 serious events

Other events: 55 other events

Deaths: 0 deaths

Ibuprofen

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	HZT-501 (Ibuprofen/Famotidine) n=132 participants at risk HZT-501: ibuprofen 800mg/famotidine 26.6mg	Ibuprofen n=47 participants at risk Ibuprofen 800mg
Gastrointestinal disorders diabetic gastroparesis	0.76% 1/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Gastrointestinal disorders esophageal stenosis	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
General disorders non-cardiac chest pain	0.76% 1/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Hepatobiliary disorders cholecystitis	0.76% 1/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Infections and infestations cellulitis	0.76% 1/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Gastrointestinal disorders gastroenteritis viral	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Metabolism and nutrition disorders diabetes mellitus	0.76% 1/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Metabolism and nutrition disorders hyperglycemia	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Metabolism and nutrition disorders hyperosmolar state	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Vascular disorders hypertension	0.76% 1/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.

Other adverse events

Measure	HZT-501 (Ibuprofen/Famotidine) n=132 participants at risk HZT-501: ibuprofen 800mg/famotidine 26.6mg	Ibuprofen n=47 participants at risk Ibuprofen 800mg
Blood and lymphatic system disorders anemia	1.5% 2/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Eye disorders cataract	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Gastrointestinal disorders abdominal pain upper	1.5% 2/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Gastrointestinal disorders abdominal tenderness	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Gastrointestinal disorders constipation	1.5% 2/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Gastrointestinal disorders diarrhea	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Gastrointestinal disorders dyspepsia	2.3% 3/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Gastrointestinal disorders esophageal stenosis	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Gastrointestinal disorders nausea	1.5% 2/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Gastrointestinal disorders vomiting	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
General disorders edema peripheral	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	4.3% 2/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
General disorders gait disturbance	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
General disorders non-cardiac chest pain	0.76% 1/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Hepatobiliary disorders cholelithiasis	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Infections and infestations bronchitis	1.5% 2/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Infections and infestations bronchitis acute	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Infections and infestations ear infection	0.76% 1/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Infections and infestations gastroenteritis viral	3.0% 4/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	4.3% 2/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Infections and infestations influenza	3.0% 4/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Infections and infestations laryngitis	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Infections and infestations otitis media	1.5% 2/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Infections and infestations sinusitis	3.8% 5/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Infections and infestations upper respiratory tract infection	2.3% 3/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Infections and infestations urinary tract infection	2.3% 3/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Infections and infestations viral upper respiratory tract infection	2.3% 3/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Injury, poisoning and procedural complications animal bite	1.5% 2/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Injury, poisoning and procedural complications contusion	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Injury, poisoning and procedural complications fall	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Injury, poisoning and procedural complications rib fracture	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Metabolism and nutrition disorders diabetes mellitus	2.3% 3/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Endocrine disorders diabetes mellitus non-insulin dependent	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Metabolism and nutrition disorders hypercholesterolemia	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Metabolism and nutrition disorders hyperglycemia	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Metabolism and nutrition disorders hyperlipidemia	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Metabolism and nutrition disorders hyperosmolar state	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Musculoskeletal and connective tissue disorders arthralgia	2.3% 3/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Musculoskeletal and connective tissue disorders back pain	2.3% 3/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Musculoskeletal and connective tissue disorders knee deformity	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Musculoskeletal and connective tissue disorders muscle spasms	2.3% 3/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Musculoskeletal and connective tissue disorders tendonitis	1.5% 2/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Nervous system disorders carpal tunnel syndrome	1.5% 2/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Nervous system disorders dizziness	1.5% 2/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Nervous system disorders nerve compression	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Psychiatric disorders anxiety	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Respiratory, thoracic and mediastinal disorders throat irritation	0.76% 1/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Skin and subcutaneous tissue disorders dermatitis	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Skin and subcutaneous tissue disorders dermatitis contact	0.00% 0/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	2.1% 1/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Skin and subcutaneous tissue disorders swelling face	1.5% 2/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.
Vascular disorders hypertension	3.0% 4/132 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.	0.00% 0/47 • 32 weeks End of Study visit occurred at Week 28. Subjects were contacted by telephone four weeks after administration of their final dose of study drug for follow-up of any AEs and to determine if they had experienced any SAEs.

Additional Information

Amy Grahn, MS Senior Vice President, Clinical Development and Operations

Horizon Pharma, Inc.

Phone: 224-383-3012

Email: agrahn@horizonpharma.com

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