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The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
Subject who have completed the 24-week Treatment Period of Horizon Protocol HZ-CA-301 or HZ-CA-303 without developing an upper gastrointestinal ulcer and who are expected to continue to require daily administration of an NSAID for the next 6 months will receive treatment with the same study medication received while participating in HZ-CA-301 or HZ-CA-303.
Study with completed results acquired from Horizon in 2024.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HZT-501 | Experimental | HZT-501: ibuprofen 800mg/famotidine 26.6mg |
|
| Ibuprofen | Active Comparator | Ibuprofen 800mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HZT-501 | Drug | Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | 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. | 28 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA International | San Diego | California | 92122 | United States |
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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | HZT-501 (Ibuprofen/Famotidine) | HZT-501: ibuprofen 800mg/famotidine 26.6mg |
| FG001 | Ibuprofen | Ibuprofen 800mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Ibuprofen |
| Drug |
Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HZT-501 (Ibuprofen/Famotidine) | HZT-501: ibuprofen 800mg/famotidine 26.6mg |
| BG001 | Ibuprofen | Ibuprofen 800mg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events | 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. | Posted | Number | participants | 28 weeks |
|
|
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HZT-501 (Ibuprofen/Famotidine) | HZT-501: ibuprofen 800mg/famotidine 26.6mg | 3 | 132 | 55 | 132 | ||
| EG001 | Ibuprofen | Ibuprofen 800mg | 2 | 47 | 16 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diabetic gastroparesis | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| esophageal stenosis | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| non-cardiac chest pain | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| cholecystitis | Hepatobiliary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| cellulitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| gastroenteritis viral | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| diabetes mellitus | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| hyperglycemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| hyperosmolar state | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| hypertension | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| cataract | Eye disorders | MedDRA (9.1) | Systematic Assessment |
| |
| abdominal pain upper | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| abdominal tenderness | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| constipation | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| diarrhea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| dyspepsia | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| esophageal stenosis | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| edema peripheral | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| gait disturbance | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| non-cardiac chest pain | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| cholelithiasis | Hepatobiliary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| bronchitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| bronchitis acute | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| ear infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| gastroenteritis viral | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| influenza | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| laryngitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| otitis media | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| sinusitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| upper respiratory tract infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| urinary tract infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| viral upper respiratory tract infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| animal bite | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| contusion | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| fall | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| rib fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| diabetes mellitus | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| diabetes mellitus non-insulin dependent | Endocrine disorders | MedDRA (9.1) | Systematic Assessment |
| |
| hypercholesterolemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| hyperglycemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| hyperlipidemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| hyperosmolar state | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| knee deformity | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| carpal tunnel syndrome | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| dizziness | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| nerve compression | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| anxiety | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| dermatitis | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| swelling face | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| hypertension | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Grahn, MS Senior Vice President, Clinical Development and Operations | Horizon Pharma, Inc. | 224-383-3012 | agrahn@horizonpharma.com |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D020918 | Complex Regional Pain Syndromes |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| >=65 years |
|
| Male |
|