Neuralgia, PostherpeticPhase 3VHPRG-HDRPHNCT01102101
Effect of Opioids in Neuropathic Pain in Postherpetic Patients
A Phase 3 study testing Remifentanil in people with Neuralgia, Postherpetic, run by Medical University of Vienna at 2 sites in Austria.
Trial summary
Postherpetic neuralgia (PHN) is often associated with pain and sensory changes and is the leading type of neuropathic pain in modern clinical pain research. It is characterized by a variety of sensory patterns, which may be categorized into "irritable nociceptor" and "impairment of nociceptor". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuralgia, Postherpetic
- What is being tested?
- Remifentanil
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 2 sitesAustria
- Study dates
- Aug 2010to Mar 2011
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from PHN.
- Pain ≥ 4 out of 10 in numeric rating scale (NRS)
- Female and male patients above the age of 18
- Ability to understand/write/read german
Who cannot join
- Zoster affecting trigeminal-, opticus region
- Any somatic pain which is stronger than the neuropathic pain
- Severe progressive disease
- Acute cardiac decompensation
- Known cardiac valve dysfunction
- Known pulmonary hypertension
Show all 17Show fewer
- Cardiac conduction disturbance
- Active herpetic lesion
- Opioid therapy
- Asthma bronchial
- Chronic obstructive pulmonary disease >GOLD II
- Severe psychiatric condition
- Abuse of alcoholic beverages, drug abuse
- Negative neuropathic symptoms
- Pregnancy or breast feeding
- Participation in a clinical trial in the 2 weeks preceding the study
- Allergy against any medication used in the study protocol
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
General Hospital Vienna, Medical University of Vienna
Vienna, State of Vienna, 1090
Bernhard Roessler, Dr, 00431404006428, bernhard.roessler@meduniwien.ac.at
Burkhard Gustorff, Prof., Dr., 00431491504001, burkhard.gustorff@meduniwien.ac.at
Wilhelminenspital der Stadt WIen
Vienna, State of Vienna, 1160
Burkhard Gustroff, Prof., Dr., 00431491504001, burkhard.gustroff@meduniwien.ac.at
Burkhard Gustroff, Prof., Dr.
About this study
Postherpetic neuralgia (PHN) is often associated with pain and sensory changes and is the leading type of neuropathic pain in modern clinical pain research. It is characterized by a variety of sensory patterns, which may be categorized into "irritable nociceptor" and "impairment of nociceptor". At date, several lines of evidence lead to the assumption, that mechanical hyperalgesia in PHN is based - at least in part - on central nervous processes of sensitization.
In animal studies the investigators have discovered a previously unrecognized effect of opioids, the reversal of long-term potentiation (LTP) at C-fibre synapses, i.e. an opioid-induced depotentiation. In principle, synaptic depotentiation may be permanent or transient. In our study the clinically used ultra-short acting MOR agonist remifentanil normalized synaptic strength after wash-out of the drug. At present it is not known whether opioid-induced depotentiation can be used to the benefit of pain patients.
The aim is to study the hypothesis, that pain in a group of PHN patients with predominant mechanical hyperalgesia is reversed by intravenous remifentanil at a plasma target concentration of 18ng/ml (corresponding to about 0.75 µg/kg/min) for 60 minutes compared with PHN patients of other sensory types.
- Conditions
- Neuralgia, Postherpetic
- Being tested
- Remifentanil
- Keywords
- Remifentanil, Hyperalgesia, Zoster, Postherpetic neuralgia
- Medical subject headings
- Neuralgia, Postherpetic, Hyperalgesia, Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called Remifentanil (Ultiva; Glaxo-Smith-Kline; Vienna, Austria)
Remifentanil (Ultiva; Glaxo-Smith-Kline; Vienna, Austria) will be applied intravenously during 60 minutes through a dedicated infusion pump (TCI Alaris PK Syringe Pump, Cardinal Health, Baesweiler, Germany), with a Target Controlled Infusion (following the integrated software algorithm by Minto), reaching the initial 18ng/ml plasma concentration in 180 seconds. This corresponds to approx. 0.7 µg kg-1 min-1.
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulus-response (SR)-function
Measured: 7 days
Secondary outcomes (9)
Pinprick
Area of secondary hyperalgesia assessed by pinprick
Measured: 7 days
Area of dynamic allodynia
Brush, Q Tip, Cotton Wool
Measured: 7 days
NRS
Pain according to numeric rating scale (NRS)
Measured: 7 days
Mechanical pain threshold
Mechanical pain threshold measured with v. Frey Filaments
Measured: 7 days
HPPT
Heat pain perception threshold (HPPT) with thermal sensory analyzer (TSA)
Measured: 7 days
HPTT
Heat pain tolerance threshold (HPTT) measured with TSA
Measured: 7 days
Coolness
Coolness perception threshold measured with TSA
Measured: 7 days
Warmth
Warmth perception threshold measured with TSA
Measured: 7 days
LDPI
Laser Doppler Perfusion Imager (LDPI) measuring superficial perfusion of the dermatome
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuralgia, PostherpeticStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 3
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- WWTF, Wiener Wissenschafts-, Forschungs- und Technologiefonds, Vienna General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102101
- Sponsor's protocol ID
- VHPRG-HighDoseRemiPostHerpetic
- Acronym
- VHPRG-HDRPH
- Status last verified
- Apr 2010
- First submitted
- 6 Apr 2010
- Last updated
- 12 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Opioids in Neuropathic Pain in Postherpetic Patients
- ClinicalTrials.gov ID
- NCT01102101
- Acronym / sponsor ID
- VHPRG-HDRPH / VHPRG-HighDoseRemiPostHerpetic
- Conditions
- Neuralgia, Postherpetic
- Keywords
- Remifentanil, Hyperalgesia, Zoster, Postherpetic neuralgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- WWTF, Wiener Wissenschafts-, Forschungs- und Technologiefonds, Vienna General Hospital
- Study start
- Aug 2010
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 12 Apr 2010 (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.
Postherpetic neuralgia (PHN) is often associated with pain and sensory changes and is the leading type of neuropathic pain in modern clinical pain research. It is characterized by a variety of sensory patterns, which may be categorized into "irritable nociceptor" and "impairment of nociceptor". At date, several lines of evidence lead to the assumption, that mechanical hyperalgesia in PHN is based - at least in part - on central nervous processes of sensitization.
In animal studies the investigators have discovered a previously unrecognized effect of opioids, the reversal of long-term potentiation (LTP) at C-fibre synapses, i.e. an opioid-induced depotentiation. In principle, synaptic depotentiation may be permanent or transient. In our study the clinically used ultra-short acting MOR agonist remifentanil normalized synaptic strength after wash-out of the drug. At present it is not known whether opioid-induced depotentiation can be used to the benefit of pain patients.
The aim is to study the hypothesis, that pain in a group of PHN patients with predominant mechanical hyperalgesia is reversed by intravenous remifentanil at a plasma target concentration of 18ng/ml (corresponding to about 0.75 µg/kg/min) for 60 minutes compared with PHN patients of other sensory types.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients suffering from PHN.
- Pain ≥ 4 out of 10 in numeric rating scale (NRS)
- Female and male patients above the age of 18
- Ability to understand/write/read german
Key exclusion criteria (17 listed)
- Zoster affecting trigeminal-, opticus region
- Any somatic pain which is stronger than the neuropathic pain
- Severe progressive disease
- Acute cardiac decompensation
- Known cardiac valve dysfunction
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 |
|---|---|---|
| RemifentanilAlso: Remifentanil (Ultiva; Glaxo-Smith-Kline; Vienna, Austria)Remifentanil (Ultiva; Glaxo-Smith-Kline; Vienna, Austria) will be applied intravenously during 60 minutes through a dedicated infusion pump (TCI Alaris PK Syringe Pump, Cardinal Health, Baesweiler, Germany), with a Target Controlled Infusion (following the integrated software algorithm by Minto), reaching the initial 18ng/ml plasma concentration in 180 seconds. This corresponds to approx. 0.7 µg kg-1 min-1. | Drug | – |
Primary outcome
Stimulus-response (SR)-function
Time frame: 7 days
9 secondary outcomes
Pinprick
Time frame: 7 days
Area of dynamic allodynia
Time frame: 7 days
NRS
Time frame: 7 days
Mechanical pain threshold
Time frame: 7 days
HPPT
Time frame: 7 days
HPTT
Time frame: 7 days
Coolness
Time frame: 7 days
Warmth
Time frame: 7 days
LDPI
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2010.
- Related InfoLink provided by the sponsor.
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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.
General Hospital Vienna, Medical University of Vienna
Vienna, Austria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remifentanil in people with Neuralgia, Postherpetic, run by Medical University of Vienna at 2 sites 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 4 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 12 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stimulus-response (SR)-function (time frame: 7 days). 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 Apr 2010.