Chronic Low Back Pain, Chronic Regional Pain Syndrome, Chronic Soft Tissue Pain, Osteoarthritis, Rheumatoid Arthritis
Conditions
Brief summary
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
Detailed description
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.
Interventions
DRUGHZT-501
Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks
DRUGIbuprofen
Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 81 Years
Healthy volunteers
No
Inclusion criteria
* Expected to continue to require daily administration of an NSAID for at least the coming 6 months. * Subject completed the 24-week Treatment period of either Horizon Protocol HZ-CA-301 or HZ-CA-303
Exclusion criteria
* Subject didn't meet all of the Inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| HZT-501 (Ibuprofen/Famotidine) HZT-501: ibuprofen 800mg/famotidine 26.6mg | 132 |
| Ibuprofen Ibuprofen 800mg | 47 |
| Total | 179 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 |
| Overall Study | Lost to Follow-up | 7 | 2 |
| Overall Study | misc | 4 | 3 |
| Overall Study | Withdrawal by Subject | 6 | 3 |
Baseline characteristics
| Characteristic | Ibuprofen | HZT-501 (Ibuprofen/Famotidine) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 22 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 110 Participants | 151 Participants |
| Age, Continuous | 53.6 years STANDARD_DEVIATION 9.3 | 55.7 years STANDARD_DEVIATION 9.6 | 55.2 years STANDARD_DEVIATION 9.6 |
| Region of Enrollment United States | 47 participants | 132 participants | 179 participants |
| Sex: Female, Male Female | 32 Participants | 90 Participants | 122 Participants |
| Sex: Female, Male Male | 15 Participants | 42 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 55 / 132 | 16 / 47 |
| serious Total, serious adverse events | 3 / 132 | 2 / 47 |
Outcome results
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.
Time frame: 28 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HZT-501 (Ibuprofen/Famotidine) | Number of Participants With Treatment Emergent Adverse Events | 55 participants |
| Ibuprofen | Number of Participants With Treatment Emergent Adverse Events | 16 participants |
p-value: 0.4228Cochran-Mantel-Haenszel