PainPhase 1TRAMADOLNCT00487175
Tramadol and Pain Sensitization
A Phase 1 study testing Tramadol in people with Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Tramadol is a largely used analgesic drug. Its role however on sensitization as occurs for example in neuropathic pain is not very well known. This protocol aims therefore at studying the effect of tramadol in a human pain model with sensitization induced by a cold stimulus, using evoked potentials to elucidate how… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Tramadol
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2007to Mar 2008
- Phase
- Phase 1
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men
- Between 18 and 40 years old
- Written consent given
Who cannot join
- Concomitant medication
- Tramadol hypersensibility
- Excessive consumption of alcohol, tobacco, coffee, tea or toxicomania
Trial locations and contacts
1 site in 1 country.
About this study
Tramadol is a largely used analgesic drug. Its role however on sensitization as occurs for example in neuropathic pain is not very well known. This protocol aims therefore at studying the effect of tramadol in a human pain model with sensitization induced by a cold stimulus, using evoked potentials to elucidate how pain is modified when tramadol is administered.
Read the detailed description
The study is a comparison of the analgesic of tramadol versus placebo in a pain model using evoked potentials. Evaluation criteria will be the amplitude of the evoked potential obtained defore and after treatment
- Conditions
- Pain
- Being tested
- Tramadol
- Keywords
- Pain, sensitization, analgesia, Healthy volunteers and pain
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
to compare of the analgesic of tramadol versus placebo in a pain model using evoked potentials
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of the evoked potential elicited by a thermal stimulus on the arm with an induced hyperalgic area
Measured: with an induced hyperalgic area
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2007
- Study completionMar 2008
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Investigators
- PICKERING Gisèle, MCU-PH, pharmacology, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487175
- Sponsor's protocol ID
- CHU63-0020
- Acronym
- TRAMADOL
- Status last verified
- Mar 2009
- First submitted
- 14 Jun 2007
- Last updated
- 17 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tramadol and Pain Sensitization
- ClinicalTrials.gov ID
- NCT00487175
- Acronym / sponsor ID
- TRAMADOL / CHU63-0020
- Conditions
- Pain
- Keywords
- Pain, sensitization, analgesia, Healthy volunteers and pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 15 Jun 2007 (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.
Tramadol is a largely used analgesic drug. Its role however on sensitization as occurs for example in neuropathic pain is not very well known. This protocol aims therefore at studying the effect of tramadol in a human pain model with sensitization induced by a cold stimulus, using evoked potentials to elucidate how pain is modified when tramadol is administered.
Detailed description
The study is a comparison of the analgesic of tramadol versus placebo in a pain model using evoked potentials. Evaluation criteria will be the amplitude of the evoked potential obtained defore and after treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men
- Between 18 and 40 years old
- Written consent given
Key exclusion criteria (3 listed)
- Concomitant medication
- Tramadol hypersensibility
- Excessive consumption of alcohol, tobacco, coffee, tea or toxicomania
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 |
|---|---|---|
| Tramadolto compare of the analgesic of tramadol versus placebo in a pain model using evoked potentials | Drug | – |
Primary outcome
Amplitude of the evoked potential elicited by a thermal stimulus on the arm with an induced hyperalgic area
Time frame: with an induced hyperalgic area
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 17 Mar 2009.
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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.
PICKERING Gisèle, MCU-PH, pharmacology principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tramadol in people with Pain, run by University Hospital, Clermont-Ferrand 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 3 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 Mar 2009. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Amplitude of the evoked potential elicited by a thermal stimulus on the arm with an induced hyperalgic area (time frame: with an induced hyperalgic area). 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 Mar 2009.