PainPhase 1NCT02602002
Experimental Medicine Study to Validate Pharmacodynamic Pain Assessments in Healthy Volunteers With an Opioid Analgesic (Remifentanil)
A Phase 1 study testing Remifentanil in people with Pain, run by GlaxoSmithKline at 1 site in South Korea.
Trial summary
This was a single centre, randomised, double blind, placebo controlled, two-way cross-over design study to assess the feasibility of pain PD tests and to determine the variability and effects of a known analgesic drug (the opioid remifentanil) in South Korean healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2008to Jun 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking, healthy adult male, aged 20-45 years inclusive.
- Body weight >50 Kg and BMI within the range 18.5-29.9 Kg/m2 inclusive
- Healthy as judged by a responsible physician. No clinically significant abnormality identified on the medical or laboratory evaluation. A subject with a clinically significant abnormality or laboratory parameters outside the reference range for the relevant age group may be included only if the Investigator and Medical Monitor consider that the finding will not introduce additional risk factors and will not interfere with the study procedures.
- A normal 12-lead ECG recording at the pre-study medical.
- Signed and dated written and informed consent must be obtained for all subjects prior to admission to the study.
- The subject is able to understand and comply with the protocol requirements, instructions and protocol-stated restrictions.
Who cannot join
- The subject has a positive pre-study urine screen for drugs of abuse or positive alcohol test.
- Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units. 1 unit is equivalent to a half-pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine.
- Use of prescription drugs as well as vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless it is the opinion of the Investigator and Medical Monitor that the medication will not interfere with the study procedures or compromise subject safety.
- History or presence of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
- Has a systolic blood pressure which is outside the range of 90 to 140 mmHg, diastolic blood pressure is outside the range of 50 to 90 mmHg or heart rate is outside the range 40 to 90 bpm.
- Has a QTcB >450 msec.
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- Has a significant medical history of dizziness, blackouts, fainting or vaso-vagal attacks.
- Has received over-the-counter (OTC) medicine within 48h before the first dosing day. Subjects who have taken OTC medication may still be entered into the study, if, in the opinion of the Principal/Co-Investigator, the medication received will not interfere with the study procedures or compromise safety.
- Has a history or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the distribution, metabolism or excretion of drugs.
- The subject has received an investigational drug or participated in any other research trial within 84 days for new chemical entities and marketed drugs or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Experimental Medicine Study to Validate Pharmacodynamic Pain Assessments in Healthy Volunteers in a Randomised, Double Blind, Placebo Controlled, 2 Way Cross-over Design With an Opioid Analgesic (Remifentanil)
This was a single centre, randomised, double blind, placebo controlled, two-way cross-over design study to assess the feasibility of pain PD tests and to determine the variability and effects of a known analgesic drug (the opioid remifentanil) in South Korean healthy volunteers.
Read the detailed description
Pain is an area of large unmet medical need and a priority disease area for GlaxoSmithKline. Selection of new candidates for pain involves tests in animal models; however, their predictive value may be limited. High risks are carried forward into Phase II Proof of Concept (PoC) studies that require large financial and time commitments.
Assessment of pain in Phase I studies can serve as a useful indicator of pharmacodynamic activity of potential analgesic treatments to reduce development risks, help make decisions about further compound progression, dose selection and design of clinical studies in pain patients. GlaxoSmithKline's Pain \& Neurophysiology group at Clinical Unit Cambridge (CUC) has developed a number of human pain models specifically tailored for GSK's portfolio and began their implementation into clinical development. Some of these models have already been used successfully to detect PD activity in Phase I [Chizh, 2007] Currently, for most candidates selected by the neurology Centre for Excellence in Drug Discovery (CEDD, there are plans to utilise human pain models as part of clinical development, including FTIH studies. Because of the limited in-house capacities, there is an ongoing effort to identify a suitable external group(s) to which some of the methodologies in pain models and PD assessments could be transferred. Involving such external groups could also help access new patient groups, such that Phase I and Phase II experimental assessments could be facilitated to provide early indication of efficacy before large scale multi-centre trials are initiated.
South Korea has been identified as a country within the Asia-Pacific region to which GlaxoSmithKline would like to collaborate more closely in terms of early phase clinical trials, particularly First Time in Human studies. A satisfactory validation study will enable us to use these methodologies in future pain studies in order to link early efficacy assessments (Phase I) with future patient studies (Phase II) within South Korea.
One group that has been identified is the Clinical Trials Center of Seoul National University Hospital. This site is being considered to perform a number of clinical studies of potential new treatments for pain.
- Conditions
- Pain
- Being tested
- Remifentanil, Placebo
- Keywords
- Remifentanil, Pharmacodynamic Pain assessments, Intravenous, South Korea
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
IV
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Remifentanil 0.1 ug/kg/min to 0.10 ug/kg/min Receives: Drug: Remifentanil |
| Placebo | Placebo comparator | Saline (0.9%) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the Heat Pain Threshold of a marketed opioid analgesic versus placebo on quantitative experimental pharmacodynamic pain markers.
Heat pain threshold
Measured: pre-dose to 67 mins
Secondary outcomes (3)
To measure the Mechanical Pain Threshold of a marketed opioid analgesic versus placebo. on quantitative experimental pharmacodynamic pain markers.
Mechanical pain threshold measurements (von Frey filaments) reported by treatment group and dose levels.
Measured: Change from Baseline (pre-dose) in mechanical pain thresholds measurements at 46 minutes
To measure the Pressure Pain Threshold of a marketed opioid analgesic versus placebo on quantitative pharmacodynamic experimental pain markers.
Mechanical pain threshold measurements (von Frey filaments) reported by treatment group and dose levels.
Measured: Change from Baseline (pre-dose) in mechanical pain thresholds measurements at 46mins
To measure the Mood and Alertness of a marketed opioid analgesic versus placebo on alertness on quantitative pharmacodynamic experimental pain markers.
Pressure pain threshold and tolerance measurements at 2 specified tender points reported by treatment group and dose levels. Mood and Alertness (Bond and Lader Visual Analogue Scale) presented graphically using box plots.
Measured: Change from Baseline (Pre-dose) in pressure pain thresholds and tolerance measurements at 46mins, 67 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startApr 2008
- Primary completionJun 2008
- Study completionJun 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.
- More trials run by GlaxoSmithKlineThe 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602002
- Sponsor's protocol ID
- 111000
- Status last verified
- Nov 2015
- First submitted
- 19 Apr 2012
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Medicine Study to Validate Pharmacodynamic Pain Assessments in Healthy Volunteers in a Randomised, Double Blind, Placebo Controlled, 2 Way Cross-over Design With an Opioid Analgesic (Remifentanil)
- ClinicalTrials.gov ID
- NCT02602002
- Acronym / sponsor ID
- 111000
- Conditions
- Pain
- Keywords
- Remifentanil, Pharmacodynamic Pain assessments, Intravenous, South Korea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 11 Nov 2015 (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.
This was a single centre, randomised, double blind, placebo controlled, two-way cross-over design study to assess the feasibility of pain PD tests and to determine the variability and effects of a known analgesic drug (the opioid remifentanil) in South Korean healthy volunteers.
Detailed description
Pain is an area of large unmet medical need and a priority disease area for GlaxoSmithKline. Selection of new candidates for pain involves tests in animal models; however, their predictive value may be limited. High risks are carried forward into Phase II Proof of Concept (PoC) studies that require large financial and time commitments.
Assessment of pain in Phase I studies can serve as a useful indicator of pharmacodynamic activity of potential analgesic treatments to reduce development risks, help make decisions about further compound progression, dose selection and design of clinical studies in pain patients. GlaxoSmithKline's Pain \& Neurophysiology group at Clinical Unit Cambridge (CUC) has developed a number of human pain models specifically tailored for GSK's portfolio and began their implementation into clinical development. Some of these models have already been used successfully to detect PD activity in Phase I [Chizh, 2007] Currently, for most candidates selected by the neurology Centre for Excellence in Drug Discovery (CEDD, there are plans to utilise human pain models as part of clinical development, including FTIH studies. Because of the limited in-house capacities, there is an ongoing effort to identify a suitable external group(s) to which some of the methodologies in pain models and PD assessments could be transferred. Involving such external groups could also help access new patient groups, such that Phase I and Phase II experimental assessments could be facilitated to provide early indication of efficacy before large scale multi-centre trials are initiated.
South Korea has been identified as a country within the Asia-Pacific region to which GlaxoSmithKline would like to collaborate more closely in terms of early phase clinical trials, particularly First Time in Human studies. A satisfactory validation study will enable us to use these methodologies in future pain studies in order to link early efficacy assessments (Phase I) with future patient studies (Phase II) within South Korea.
One group that has been identified is the Clinical Trials Center of Seoul National University Hospital. This site is being considered to perform a number of clinical studies of potential new treatments for pain.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: RemifentanilRemifentanil 0.1 ug/kg/min to 0.10 ug/kg/min |
| Placebo | Placebo comparator | Drug: PlaceboSaline (0.9%) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Non-smoking, healthy adult male, aged 20-45 years inclusive.
- Body weight >50 Kg and BMI within the range 18.5-29.9 Kg/m2 inclusive
- Healthy as judged by a responsible physician. No clinically significant abnormality identified on the medical or laboratory evaluation. A subject with a clinically significant abnormality or laboratory parameters outside the reference range for the relevant age group may be included only if the Investigator and Medical Monitor consider that the finding will not introduce additional risk factors and will not interfere with the study procedures.
- A normal 12-lead ECG recording at the pre-study medical.
- Signed and dated written and informed consent must be obtained for all subjects prior to admission to the study.
Key exclusion criteria (10 listed)
- The subject has a positive pre-study urine screen for drugs of abuse or positive alcohol test.
- Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units. 1 unit is equivalent to a half-pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine.
- Use of prescription drugs as well as vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless it is the opinion of the Investigator and Medical Monitor that the medication will not interfere with the study procedures or compromise subject safety.
- History or presence of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
- Has a systolic blood pressure which is outside the range of 90 to 140 mmHg, diastolic blood pressure is outside the range of 50 to 90 mmHg or heart rate is outside the range 40 to 90 bpm.
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 |
|---|---|---|
| RemifentanilIV | Drug | Active |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
To measure the Heat Pain Threshold of a marketed opioid analgesic versus placebo on quantitative experimental pharmacodynamic pain markers.
Time frame: pre-dose to 67 mins
Heat pain threshold
3 secondary outcomes
To measure the Mechanical Pain Threshold of a marketed opioid analgesic versus placebo. on quantitative experimental pharmacodynamic pain markers.
Time frame: Change from Baseline (pre-dose) in mechanical pain thresholds measurements at 46 minutes
To measure the Pressure Pain Threshold of a marketed opioid analgesic versus placebo on quantitative pharmacodynamic experimental pain markers.
Time frame: Change from Baseline (pre-dose) in mechanical pain thresholds measurements at 46mins
To measure the Mood and Alertness of a marketed opioid analgesic versus placebo on alertness on quantitative pharmacodynamic experimental pain markers.
Time frame: Change from Baseline (Pre-dose) in pressure pain thresholds and tolerance measurements at 46mins, 67 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 11 Nov 2015.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 Remifentanil in people with Pain, run by GlaxoSmithKline at 1 site in South Korea.
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 6 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 11 Nov 2015. 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 South Korea. 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 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?
To measure the Heat Pain Threshold of a marketed opioid analgesic versus placebo on quantitative experimental pharmacodynamic pain markers. (time frame: pre-dose to 67 mins). 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 11 Nov 2015.