HeadacheNCT01327118
Prostaglandin F2alpha in a Human Headache Model
A study testing Prostaglandin F2alpha and Isoton sodium chloride in people with Headache, run by Danish Headache Center at 1 site in Denmark.
Trial summary
The hypothesis of this study is that PGF2alpha does not induce headache or dilatation of brain vessels. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache
- What is being tested?
- Prostaglandin F2alpha and Isoton sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2010to Dec 2010
- Phase
- Interventional
- 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
- Healthy volunteers
Who cannot join
- Primary Headache
- Headache on the day of the investigation
- Hypertension
- Hypotension
- Pregnant/nursing
- Daily intake of medication (except oral contraceptives)
Show all 9Show fewer
- Cardiovascular or central nervous system (CNS) disease
- Drug/alcohol abuse
- Psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of Prostaglandin F2alpha
The hypothesis of this study is that PGF2alpha does not induce headache or dilatation of brain vessels.
- Conditions
- Headache
- Being tested
- Prostaglandin F2alpha, Isoton sodium chloride
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostaglandin F2alphaDrug
Also called Dinoprost
intravenous injection
Isoton sodium chlorideDrug
Also called placebo
intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Isoton sodium chloride | Placebo comparator | Not described Receives: Drug: Isoton sodium chloride |
| Prostaglandin F2alpha | Active comparator | Not described Receives: Drug: Prostaglandin F2alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache score on a 10-point verbal rating scale (VRS) 0 indicated no headache; 1 indicated a different sensation, pounding or throbbing, but not necessarily painful; 5 indicated moderate headache and 10 indicated worst imaginable headache
incidence of headache
Measured: 24 h.
Secondary outcomes (4)
Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz)
changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.
Measured: in-hospital 2 h.
diameter of superficial temporal artery and radial artery measured by a high resolution ultrasound scanner, C-scan
changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.
Measured: in-hospital 2 h.
mean arterial blood pressure (MAP), heart rate (HR), end-tidal partial pressure of pCO2 (PetCO2), transcutaneous arterial oxygen saturation (SAT) measured by ProPac Encore®
changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.
Measured: in-hospital 2 h.
electrocardiography (ECG)
changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.
Measured: in-hospital 2 h.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startSep 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Investigators
- Troels Wienecke, MD,PhD, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327118
- Sponsor's protocol ID
- DHC-PGF2-2010
- Status last verified
- Jul 2010
- First submitted
- 29 Mar 2011
- Last updated
- 14 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of Prostaglandin F2alpha
- ClinicalTrials.gov ID
- NCT01327118
- Acronym / sponsor ID
- DHC-PGF2-2010
- Conditions
- Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Apr 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.
The hypothesis of this study is that PGF2alpha does not induce headache or dilatation of brain vessels.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isoton sodium chloride | Placebo comparator | Drug: Isoton sodium chloride |
| Prostaglandin F2alpha | Active comparator | Drug: Prostaglandin F2alpha |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (9 listed)
- Primary Headache
- Headache on the day of the investigation
- Hypertension
- Hypotension
- Pregnant/nursing
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 |
|---|---|---|
| Prostaglandin F2alphaAlso: Dinoprostintravenous injection | Drug | Prostaglandin F2alpha |
| Isoton sodium chlorideAlso: placebointravenous injection | Drug | Isoton sodium chloride |
Primary outcome
Headache score on a 10-point verbal rating scale (VRS) 0 indicated no headache; 1 indicated a different sensation, pounding or throbbing, but not necessarily painful; 5 indicated moderate headache and 10 indicated worst imaginable headache
Time frame: 24 h.
incidence of headache
4 secondary outcomes
Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz)
Time frame: in-hospital 2 h.
diameter of superficial temporal artery and radial artery measured by a high resolution ultrasound scanner, C-scan
Time frame: in-hospital 2 h.
mean arterial blood pressure (MAP), heart rate (HR), end-tidal partial pressure of pCO2 (PetCO2), transcutaneous arterial oxygen saturation (SAT) measured by ProPac Encore®
Time frame: in-hospital 2 h.
electrocardiography (ECG)
Time frame: in-hospital 2 h.
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 14 Apr 2011.
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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.
Troels Wienecke, MD,PhD principal investigator
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostaglandin F2alpha and Isoton sodium chloride in people with Headache, run by Danish Headache Center at 1 site in Denmark.
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 1 inclusion and 9 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 14 Apr 2011. 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 Denmark. 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.
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?
Headache score on a 10-point verbal rating scale (VRS) 0 indicated no headache; 1 indicated a different sensation, pounding or throbbing, but not necessarily painful; 5 indicated moderate headache and 10 indicated worst imaginable headache (time frame: 24 h.). 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 14 Apr 2011.