OsteoarthritisPhase 3HZ-CA-304NCT00613106
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)
A Phase 3 study testing HZT-501 and Ibuprofen in people with Osteoarthritis and Rheumatoid Arthritis, run by Amgen at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501. Read more about this study
- Who is it for?
- Ages 40 to 81 years
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Chronic Low Back Pain
- What is being tested?
- HZT-501 and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Oct 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subject didn't meet all of the Inclusion and Exclusion Criteria for Horizon Protocol HZ-CA-301 or HZ-CA-303
- Subject developed or experienced any of the following while on either HZ-CA-301 or HZ-CA-303
- Malignant Disease of the gastrointestinal tract
- Erosive esophagitis
- Clinically significant cardiac, renal or hepatic disease
- Uncontrolled diabetes
- Positive pregnancy test on Study Day 0
- Please note that there are other additional criteria. The study center will determine if you meet all of the criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-Blind Follow-On Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg)in Subjects Who Have Completed Participation in Horizon Protocol HZ-CA-301 (NCT00450658)or Horizon Protocol HZ-CA-303 (NCT00450216)
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
Read the 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.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Chronic Low Back Pain, Chronic Regional Pain Syndrome, Chronic Soft Tissue Pain
- Being tested
- HZT-501, Ibuprofen
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HZT-501Drug
Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks
IbuprofenDrug
Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks
| Study group | Role | What they receive |
|---|---|---|
| HZT-501 | Experimental | HZT-501: ibuprofen 800mg/famotidine 26.6mg Receives: Drug: HZT-501 |
| Ibuprofen | Active comparator | Ibuprofen 800mg Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2008 (estimated)
- Study startSep 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613106
- Sponsor's protocol ID
- HZ-CA-304
- Acronym
- HZ-CA-304
- Status last verified
- Nov 2024
- First submitted
- 28 Jan 2008
- Last updated
- 17 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Follow-On Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg)in Subjects Who Have Completed Participation in Horizon Protocol HZ-CA-301 (NCT00450658)or Horizon Protocol HZ-CA-303 (NCT00450216)
- ClinicalTrials.gov ID
- NCT00613106
- Acronym / sponsor ID
- HZ-CA-304 / HZ-CA-304
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Chronic Low Back Pain, Chronic Regional Pain Syndrome, Chronic Soft Tissue Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 12 Feb 2008 (estimated)
- Results
- Posted 17 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HZT-501 | Experimental | Drug: HZT-501HZT-501: ibuprofen 800mg/famotidine 26.6mg |
| Ibuprofen | Active comparator | Drug: IbuprofenIbuprofen 800mg |
Who may qualify
- Ages
- 40 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- Subject didn't meet all of the Inclusion and Exclusion Criteria for Horizon Protocol HZ-CA-301 or HZ-CA-303
- Subject developed or experienced any of the following while on either HZ-CA-301 or HZ-CA-303
- Malignant Disease of the gastrointestinal tract
- Erosive esophagitis
- Clinically significant cardiac, renal or hepatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HZT-501Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks | Drug | HZT-501 |
| IbuprofenIbuprofen 800mg administered orally 3 times daily for at least 28 weeks | Drug | Ibuprofen |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HZT-501 and Ibuprofen in people with Osteoarthritis and Rheumatoid Arthritis, run by Amgen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.