Neuropathic Post-zosterian PainNCT00989040
Impact of Neuropathic Post-Zosterian Pain on the Cognition
An observational study of Neuropathic Post-zosterian Pain and Cognition, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Pain is defined as a sensorial and emotional phenomenon and lead consequences on the cognition. These consequences could be increased with usual treatment. So the aim of this study is to explore these cognitive consequences. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Post-zosterian Pain, Cognition
- What is being tested?
- usual treatment: Versatis
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Sep 2009
- Phase
- Observational
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who suffer of neuropathic post-zosteria pain
Who may be able to join
- Patient suffering of NPZ pain
- Over 55 years old
- Healthy volunteers
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Neuropathic Post-zosterian Pain on the Cognition (NPZ and Cognition)
Pain is defined as a sensorial and emotional phenomenon and lead consequences on the cognition. These consequences could be increased with usual treatment. So the aim of this study is to explore these cognitive consequences.
Read the detailed description
Pilot prospective study with parallel groups
- Conditions
- Neuropathic Post-zosterian Pain, Cognition
- Being tested
- usual treatment: Versatis
- Keywords
- NPZ, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usual treatment: VersatisDrug
- To explore if the cognition is failed in treated patients suffering of neuropathic postzosteria pain.
- To see if treated patients with patch (Versatis®) have better cognition than treated patients without patch.
What is being measured
The primary outcome is the main question the study is designed to answer.
The principal outcome is to explore if the cognition is failed in treated patients suffering of neuropathic post-zosteria pain.
Measured: at day 1
Secondary outcomes (1)
Study if treated patients with patch (Versatis®) have better cognition than treated patients without patch.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2009
- Study completionSep 2009
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 Neuropathic Post-zosterian PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claude Dubray, PUPH, Principal investigator, CIC-CPC Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989040
- Sponsor's protocol ID
- CHU-0049
- Status last verified
- Jan 2012
- First submitted
- 13 Mar 2009
- Last updated
- 30 Jan 2012
- Results posted
- No
Publications
Pickering G, Pereira B, Clere F, Sorel M, de Montgazon G, Navez M, Picard P, Roux D, Morel V, Salimani R, Adda M, Legout V, Dubray C. Cognitive function in older patients with postherpetic neuralgia. Pain Pract. 2014 Jan;14(1):E1-7. doi: 10.1111/papr.12079. Epub 2013 May 23.
PubMed 23701810
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Neuropathic Post-zosterian Pain on the Cognition (NPZ and Cognition)
- ClinicalTrials.gov ID
- NCT00989040
- Acronym / sponsor ID
- CHU-0049
- Conditions
- Neuropathic Post-zosterian Pain, Cognition
- Keywords
- NPZ, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 2 Oct 2009 (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.
Pain is defined as a sensorial and emotional phenomenon and lead consequences on the cognition. These consequences could be increased with usual treatment. So the aim of this study is to explore these cognitive consequences.
Detailed description
Pilot prospective study with parallel groups
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who suffer of neuropathic post-zosteria pain
Key inclusion criteria (3 listed)
- Patient suffering of NPZ pain
- Over 55 years old
- Healthy volunteers
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| usual treatment: Versatis* To explore if the cognition is failed in treated patients suffering of neuropathic postzosteria pain. * To see if treated patients with patch (Versatis®) have better cognition than treated patients without patch. | Drug | – |
Primary outcome
The principal outcome is to explore if the cognition is failed in treated patients suffering of neuropathic post-zosteria pain.
Time frame: at day 1
1 secondary outcome
Study if treated patients with patch (Versatis®) have better cognition than treated patients without patch.
Time frame: at day 1
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 30 Jan 2012.
- Derived from this study: PubMed 23701810Pickering G, Pereira B, Clere F, Sorel M, de Montgazon G, Navez M, Picard P, Roux D, Morel V, Salimani R, Adda M, Legout V, Dubray C. Cognitive function in older patients with postherpetic neuralgia. Pain Pract. 2014 Jan;14(1):E1-7. doi: 10.1111/papr.12079. Epub 2013 May 23.
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.
Claude Dubray, PUPH principal investigator
CIC-CPC Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Post-zosterian Pain and Cognition, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 0 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 30 Jan 2012. 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 France. 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.
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?
The principal outcome is to explore if the cognition is failed in treated patients suffering of neuropathic post-zosteria pain. (time frame: at day 1). 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 NCT00989040, 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 30 Jan 2012.