Acute Coronary SyndromesPhase 4NCT00718406
Pain Relief of Metoprolol Versus Metoprolol Plus Morphine in Acute Chest Pain
A Phase 4 study testing Metoprolol and metoprolol plus morphine in people with Acute Coronary Syndromes, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The primary aim was to evaluate the relief of chest pain during the first 30 minutes among patients who received metoprolol alone as compared with metoprolol plus morphine Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- Metoprolol and metoprolol plus morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSweden
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acute chest pain
- ECG-signs indicating myocardial ischemia
Who cannot join
- Heart rate < 60 beats/min
- Systolic blood pressure < 110 mmHg
- High degree AV-block
- Signs of obstructive pulmonary disease
- Signs of pulmonary oedema
- Unwillingness
- Participation in other studies
- Long delay between arrival of ambulance and randomisation
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Medical Institution, Dept of Molecular and Clinical Medicine, Sahlgrenska University Hospital
Gothenburg, SE-413 45
About this study
The primary aim was to evaluate the relief of chest pain during the first 30 minutes among patients who received metoprolol alone as compared with metoprolol plus morphine
- Conditions
- Acute Coronary Syndromes
- Being tested
- Metoprolol, metoprolol plus morphine
- Keywords
- Acute coronary syndrome, Chest pain, Betablockers, Morphine, Prehospital phase
- Medical subject headings
- Acute Coronary Syndrome, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoprololDrug
metoprolol plus morphineDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | A=metoprolol Receives: Drug: Metoprolol |
| B | Active comparator | B=metoprolol plus morphine Receives: Drug: metoprolol plus morphine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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 4
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718406
- Sponsor's protocol ID
- S203-02
- Status last verified
- Aug 2002
- First submitted
- 16 Jul 2008
- Last updated
- 18 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Relief of Metoprolol Versus Metoprolol Plus Morphine in Acute Chest Pain
- ClinicalTrials.gov ID
- NCT00718406
- Acronym / sponsor ID
- S203-02
- Conditions
- Acute Coronary Syndromes
- Keywords
- Acute coronary syndrome, Chest pain, Betablockers, Morphine, Prehospital phase
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca
- First posted
- 18 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim was to evaluate the relief of chest pain during the first 30 minutes among patients who received metoprolol alone as compared with metoprolol plus morphine
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: MetoprololA=metoprolol |
| B | Active comparator | Drug: metoprolol plus morphineB=metoprolol plus morphine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Acute chest pain
- ECG-signs indicating myocardial ischemia
Key exclusion criteria (8 listed)
- Heart rate < 60 beats/min
- Systolic blood pressure < 110 mmHg
- High degree AV-block
- Signs of obstructive pulmonary disease
- Signs of pulmonary oedema
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 |
|---|---|---|
| Metoprolol | Drug | A |
| metoprolol plus morphine | Drug | B |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metoprolol and metoprolol plus morphine in people with Acute Coronary Syndromes, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 18 Jul 2008. 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 Sweden. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 18 Jul 2008.