PainPhase 4Trama-CodeNCT01782846
Trama-Code (Two Analgesics-comparative Study)
A Phase 4 study testing Ixprim® and Dafalgan-Codeine® in people with Pain, run by Hopital Foch at 1 site in France.
Trial summary
Double-blind randomized study to compare the efficacy of two analgesic drugs(Ixprim®, Dafalgan-Codeine®) in the emergency unit. The efficacy (relief of pain) would be assessed 2 hours after administration of one of the two drugs in a patient presented to the emergency unit with a moderate pain (4 to 6 on pain… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- Ixprim® and Dafalgan-Codeine®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 803 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Apr 2013
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of 18 - 75 years of age
- Presented to the emergency unit of FOCH hospital
- Complaining of moderate pain (4-6 on pain assessment scale) evaluated by the reception nurse
Who cannot join
- Patient already had received another type 2 analgesia or already received one of the study drugs in the last 4 hours
- pregnant or lactating females
- Patient with one or more contraindication to one of the study drugs
- Patients for whom the pain assessment scale can not be performed (unconscious, confused ...)
- Patient cannot be included for legal reasons
- Patient required urgent management
- Patient for whom it is considered difficult to be reassessed 2 hours later
- Patient unable to swallow
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital FOCH - Emergency unit
Suresnes, Île-de-France Region, 92150
About this study
Official title: Double Blind-randomized Study Comparing the Efficacy of Two Analgesia (Ixprim® and Dafalgan-Codeine®) , in the Emergency Unit.
Double-blind randomized study to compare the efficacy of two analgesic drugs(Ixprim®, Dafalgan-Codeine®) in the emergency unit.
The efficacy (relief of pain) would be assessed 2 hours after administration of one of the two drugs in a patient presented to the emergency unit with a moderate pain (4 to 6 on pain assessment score).
- Conditions
- Pain
- Being tested
- Ixprim®, Dafalgan-Codeine®
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ixprim®Drug
Dafalgan-Codeine®Drug
| Study group | Role | What they receive |
|---|---|---|
| Ixprim® | Active comparator | 2 capsules of Ixprim® given orally (1000 mg Paracetamol + 75 mg Tramadol) Receives: Drug: Ixprim® |
| Dafalgan Codeine® | Active comparator | Two capsules of Dafalgan Codeine® given orally (1000 mg Paracetamol + 46.8 mg Codeine) Receives: Drug: Dafalgan-Codeine® |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain improvement
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startMar 2011
- Primary completionFeb 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 803 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782846
- Sponsor's protocol ID
- 2010/45
- Acronym
- Trama-Code
- Status last verified
- Apr 2016
- First submitted
- 25 Jan 2013
- Last updated
- 20 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind-randomized Study Comparing the Efficacy of Two Analgesia (Ixprim® and Dafalgan-Codeine®) , in the Emergency Unit.
- ClinicalTrials.gov ID
- NCT01782846
- Acronym / sponsor ID
- Trama-Code / 2010/45
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 803 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 4 Feb 2013 (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.
Double-blind randomized study to compare the efficacy of two analgesic drugs(Ixprim®, Dafalgan-Codeine®) in the emergency unit.
The efficacy (relief of pain) would be assessed 2 hours after administration of one of the two drugs in a patient presented to the emergency unit with a moderate pain (4 to 6 on pain assessment score).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ixprim® | Active comparator | Drug: Ixprim®2 capsules of Ixprim® given orally (1000 mg Paracetamol + 75 mg Tramadol) |
| Dafalgan Codeine® | Active comparator | Drug: Dafalgan-Codeine®Two capsules of Dafalgan Codeine® given orally (1000 mg Paracetamol + 46.8 mg Codeine) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of 18 - 75 years of age
- Presented to the emergency unit of FOCH hospital
- Complaining of moderate pain (4-6 on pain assessment scale) evaluated by the reception nurse
Key exclusion criteria (8 listed)
- Patient already had received another type 2 analgesia or already received one of the study drugs in the last 4 hours
- pregnant or lactating females
- Patient with one or more contraindication to one of the study drugs
- Patients for whom the pain assessment scale can not be performed (unconscious, confused ...)
- Patient cannot be included for legal reasons
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 |
|---|---|---|
| Ixprim® | Drug | Ixprim® |
| Dafalgan-Codeine® | Drug | Dafalgan Codeine® |
Primary outcome
pain improvement
Time frame: 120 minutes
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 20 Apr 2016.
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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 Ixprim® and Dafalgan-Codeine® in people with Pain, run by Hopital Foch at 1 site in France.
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 3 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 20 Apr 2016. 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 France. 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.
What does the primary outcome measure?
pain improvement (time frame: 120 minutes). 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 20 Apr 2016.