PainPhase 4NCT01419405
Pregabalin and Remifentanil - Analgesia and Ventilation
A Phase 4 study testing Pregabalin, Remifentanil and sugar pill, saline infusion in people with Pain, run by Oslo University Hospital at 1 site in Norway.
Trial summary
In this experimental study on healthy volunteers we explored the effect of pregabalin alone and in combination with remifentanil on acute experimental pain and ventilatory function. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Pregabalin, Remifentanil and sugar pill, saline infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2011to Mar 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers,
- > 18 yrs < 55 yrs,
- negative pregnancy test
Who cannot join
- Pregnancy,
- nursing,
- known heart-, lung- or liver disease,
- kidney failure/peptic ulcers,
- use of liver enzyme-inducing medications,
- known allergy against the medications used in the trial,
Show all 10Show fewer
- use of psychotropic drugs, analgesics or alcohol used the last 24 hours before the trial,
- body weight > 100 kg or 30% deviation from normal weight,
- participant in other studies during the last 2 months,
- individuals who do not master Norwegian language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pregabalin Has Additive Analgesic and Ventilatory Depressive Effects in Combination With Remifentanil
In this experimental study on healthy volunteers we explored the effect of pregabalin alone and in combination with remifentanil on acute experimental pain and ventilatory function.
Read the detailed description
Pain during cold pressor test (CPT) was scored at all dose levels of remifentanil on a visual analogue scale (VAS 0-100 mm). Ventilatory function was measured by spirometry registering respiratory frequency (breaths/min), minute volume (L/min) and expiratory end-tidal carbon dioxide tension (mmHg).
Side effects such as nausea and sedation were registered.
- Conditions
- Pain
- Being tested
- Pregabalin, Remifentanil, sugar pill, saline infusion
- Keywords
- analgesia, acute experimental pain, cold pressor test, pregabalin, remifentanil
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
hard capsule, 150 mg, 2 times, 2 days
RemifentanilDrug
Also called Ultiva
50-90 min: TCI 0.6 ng/mL, 100-140 min: 1.2 ng/mL, 150-190 min: TCI 2.4 ng/mL
sugar pill, saline infusionDrug
Also called Laktose monohydrat, NaCl 0,9%
hard capsule, 150 mg, 2 times, 2 days, saline infusion
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin/placebo | Experimental | Not described Receives: Drug: Pregabalin |
| placebo/remifentanil | Active comparator | Not described Receives: Drug: Remifentanil |
| placebo/placebo | Placebo comparator | Not described Receives: Drug: sugar pill, saline infusion |
| Pregabalin/Remifentanil | Experimental | Not described Receives: Drug: Pregabalin; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain was caused by Cold Pressure Test
Measured: 123 sec x 4
Secondary outcomes (2)
Ventilatory function
Respiratory frequence (breath/min), tidal volume (mL), minute volume (L)and expiratory end-tidal carbon dioxide tension (mmHg)
Measured: 10 min x 4
Cognitive function
Cognitive function was tested using pc-tests like Cambridge Neuropsychological Test Automated Battery (CANTAB) and Stroop-test
Measured: 4 min x 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2012
- Study completionMar 2012
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.
- More trials run by Oslo 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audun Stubhaug, MD, DMedSci, Prof., Principal investigator, Oslo University Hospital HF, Division of Critical Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419405
- Sponsor's protocol ID
- 2011/1380-1
- Status last verified
- Sep 2014
- First submitted
- 30 Jun 2011
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregabalin Has Additive Analgesic and Ventilatory Depressive Effects in Combination With Remifentanil
- ClinicalTrials.gov ID
- NCT01419405
- Acronym / sponsor ID
- 2011/1380-1
- Conditions
- Pain
- Keywords
- analgesia, acute experimental pain, cold pressor test, pregabalin, remifentanil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 18 Aug 2011 (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.
In this experimental study on healthy volunteers we explored the effect of pregabalin alone and in combination with remifentanil on acute experimental pain and ventilatory function.
Detailed description
Pain during cold pressor test (CPT) was scored at all dose levels of remifentanil on a visual analogue scale (VAS 0-100 mm). Ventilatory function was measured by spirometry registering respiratory frequency (breaths/min), minute volume (L/min) and expiratory end-tidal carbon dioxide tension (mmHg).
Side effects such as nausea and sedation were registered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregabalin/placebo | Experimental | Drug: Pregabalin |
| placebo/remifentanil | Active comparator | Drug: Remifentanil |
| placebo/placebo | Placebo comparator | Drug: sugar pill, saline infusion |
| Pregabalin/Remifentanil | Experimental | Drug: Pregabalin, Drug: Remifentanil |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers,
- > 18 yrs < 55 yrs,
- negative pregnancy test
Key exclusion criteria (10 listed)
- Pregnancy,
- nursing,
- known heart-, lung- or liver disease,
- kidney failure/peptic ulcers,
- use of liver enzyme-inducing medications,
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 |
|---|---|---|
| PregabalinAlso: Lyricahard capsule, 150 mg, 2 times, 2 days | Drug | Pregabalin/Remifentanil, Pregabalin/placebo |
| RemifentanilAlso: Ultiva50-90 min: TCI 0.6 ng/mL, 100-140 min: 1.2 ng/mL, 150-190 min: TCI 2.4 ng/mL | Drug | Pregabalin/Remifentanil, placebo/remifentanil |
| sugar pill, saline infusionAlso: Laktose monohydrat, NaCl 0,9%hard capsule, 150 mg, 2 times, 2 days, saline infusion | Drug | placebo/placebo |
Primary outcome
Pain intensity
Time frame: 123 sec x 4
Pain was caused by Cold Pressure Test
2 secondary outcomes
Ventilatory function
Time frame: 10 min x 4
Cognitive function
Time frame: 4 min x 4
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 12 Sep 2014.
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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.
Audun Stubhaug, MD, DMedSci, Prof. principal investigator
Oslo University Hospital HF, Division of Critical Care
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 Pregabalin, Remifentanil and sugar pill, saline infusion in people with Pain, run by Oslo University Hospital at 1 site in Norway.
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 10 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 12 Sep 2014. 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 Norway. 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. Some participants in this study may receive a placebo. 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 intensity (time frame: 123 sec x 4). 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 12 Sep 2014.