Analgesic DrugsPhase 4GabA01NCT02629146
Analgesic Effects of Midazolam in Human Volunteers
A Phase 4 study testing Midazolam, Fentanyl and Isotonic saline in people with Analgesic Drugs and Antinociceptive Agents, run by Wilhelminenspital Vienna at 1 site in Austria.
Trial summary
This study evaluates analgesic properties of midazolam compared to placebo and fentanyl. Each participant will receive all three drugs (midazolam, fentanyl, placebo) on three different occasions (study visits) and the effect on different pain stimuli will be tested. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesic Drugs, Antinociceptive Agents
- What is being tested?
- Midazolam, Fentanyl and Isotonic saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2015to Mar 2016
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male and female volunteers
- 18-40 years old
- healthy
- body mass index between 5th and 85th percentile
- Caucasian
- non smoker or moderate smoker (<10 cigarettes per day)
- able to understand, write, and read German
Who cannot join
- acute or chronic pain condition (except for mild day-to-day pain on <5 days/month)
- previous (up to 5 days preceding the study) or current medications prescription or over-the-counter, especially analgesics
- symptoms of a clinically relevant illness in the 2 weeks before the first study day
- hypertension
- any known psychiatric condition
- abuse of alcoholic beverages, drug abuse
Show all 15Show fewer
- known positive human immunodeficiency virus status
- any known medical condition which may interact with study medication, study objectives, or compliance of subject with study tasks
- participation in a clinical trial in the 4 weeks preceding the study
- known allergy against Midazolam
- known allergy against Fentanyl
- pregnancy or breast-feeding
- unable or unwilling to give informed consent
- unable or unwilling to follow investigator's instructions
- unable or unwilling to comply with study protocol
Trial locations and contacts
1 site in 1 country.
Austria1 site
Schmerzdiagnostik / Clinical Research Unit
Vienna, State of Vienna, 1190
About this study
Official title: A Single Center, Prospective, Randomized, Double Blind, Placebo-controlled, Three-way Cross-over Study of the Analgesic Effects of Midazolam Versus Placebo With Fentanyl as an Active Control in Human Volunteers
This study evaluates analgesic properties of midazolam compared to placebo and fentanyl. Each participant will receive all three drugs (midazolam, fentanyl, placebo) on three different occasions (study visits) and the effect on different pain stimuli will be tested.
- Conditions
- Analgesic Drugs, Antinociceptive Agents
- Keywords
- Midazolam, Fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Midazolam | Experimental | Drug: Midazolam (experimental) Receives: Drug: Midazolam |
| Isotonic saline | Placebo comparator | Drug: Isotonic saline (placebo) Receives: Drug: Isotonic saline |
| Fentanyl | Active comparator | Drug: Fentanyl (active comparator) Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain ratings (0-100) to a suprathreshold heat pain stimulus
Measured: 3.5 Minutes after end of infusion
Secondary outcomes (2)
Change in pain ratings to a suprathreshold electrical pain stimulus
Measured: 3.5 Minutes after end of infusion
Increase of pressure pain thresholds (kPa)
Measured: Up until 23 Minutes after end of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Analgesic DrugsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wilhelminenspital Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Akron Molecules AG
- Responsible party
- Principal investigator, Burkhard Gustorff, Wilhelminenspital Vienna
- Investigators
- Burkhard Gustorff, Prof.Dr., Principal investigator, Wilhelminenspital Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629146
- Sponsor's protocol ID
- GabA01
- Acronym
- GabA01
- Status last verified
- Mar 2016
- First submitted
- 6 Dec 2015
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Laursen DR, Nejstgaard CH, Bjorkedal E, Frost AD, Hansen MR, Paludan-Muller AS, Prosenz J, Werner CP, Hrobjartsson A. Impact of active placebo controls on estimated drug effects in randomised trials: a systematic review of trials with both active placebo and standard placebo. Cochrane Database Syst Rev. 2023 Mar 6;3(3):MR000055. doi: 10.1002/14651858.MR000055.pub2.
PubMed 36877132
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Prospective, Randomized, Double Blind, Placebo-controlled, Three-way Cross-over Study of the Analgesic Effects of Midazolam Versus Placebo With Fentanyl as an Active Control in Human Volunteers
- ClinicalTrials.gov ID
- NCT02629146
- Acronym / sponsor ID
- GabA01 / GabA01
- Conditions
- Analgesic Drugs, Antinociceptive Agents
- Keywords
- Midazolam, Fentanyl
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wilhelminenspital ViennaUniversity, hospital or other
- Collaborators
- Akron Molecules AG
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Dec 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 study evaluates analgesic properties of midazolam compared to placebo and fentanyl. Each participant will receive all three drugs (midazolam, fentanyl, placebo) on three different occasions (study visits) and the effect on different pain stimuli will be tested.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Midazolam | Experimental | Drug: MidazolamDrug: Midazolam (experimental) |
| Isotonic saline | Placebo comparator | Drug: Isotonic salineDrug: Isotonic saline (placebo) |
| Fentanyl | Active comparator | Drug: FentanylDrug: Fentanyl (active comparator) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- male and female volunteers
- 18-40 years old
- healthy
- body mass index between 5th and 85th percentile
- Caucasian
Key exclusion criteria (15 listed)
- acute or chronic pain condition (except for mild day-to-day pain on <5 days/month)
- previous (up to 5 days preceding the study) or current medications prescription or over-the-counter, especially analgesics
- symptoms of a clinically relevant illness in the 2 weeks before the first study day
- hypertension
- any known psychiatric condition
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 |
|---|---|---|
| MidazolamAlso: Dormicum | Drug | Midazolam |
| Fentanyl | Drug | Fentanyl |
| Isotonic saline | Drug | Isotonic saline |
Primary outcome
Change in pain ratings (0-100) to a suprathreshold heat pain stimulus
Time frame: 3.5 Minutes after end of infusion
2 secondary outcomes
Change in pain ratings to a suprathreshold electrical pain stimulus
Time frame: 3.5 Minutes after end of infusion
Increase of pressure pain thresholds (kPa)
Time frame: Up until 23 Minutes after end of infusion
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 Mar 2016.
- Derived from this study: PubMed 36877132Laursen DR, Nejstgaard CH, Bjorkedal E, Frost AD, Hansen MR, Paludan-Muller AS, Prosenz J, Werner CP, Hrobjartsson A. Impact of active placebo controls on estimated drug effects in randomised trials: a systematic review of trials with both active placebo and standard placebo. Cochrane Database Syst Rev. 2023 Mar 6;3(3):MR000055. doi: 10.1002/14651858.MR000055.pub2.
- Individual participant dataSharing planned: No
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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.
Burkhard Gustorff, Prof.Dr. principal investigator
Wilhelminenspital Vienna
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 Midazolam, Fentanyl and Isotonic saline in people with Analgesic Drugs and Antinociceptive Agents, run by Wilhelminenspital Vienna at 1 site in Austria.
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 7 inclusion and 15 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 Mar 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 Austria. 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?
Change in pain ratings (0-100) to a suprathreshold heat pain stimulus (time frame: 3.5 Minutes after end of infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02629146, which also lists 1 linked publication.
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 Mar 2016.