Post-herpetic NeuralgiaPhase 3NPHNCT01752699
Methadone in Post-Herpetic Neuralgia Pain
A Phase 3 study testing Methadone in people with Post-herpetic Neuralgia, run by University of Sao Paulo.
Trial summary
Neuropathic pain is a common condition and affecting 40 to 70% of the general population. Post-herpetic neuralgia is a condition almost complex and requires a multi modal treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-herpetic Neuralgia
- What is being tested?
- Methadone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 1998to Mar 2013
- 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 with chronic (>6 months) symptomatic PHN
- with visual analogical scale >40/100mm
- use of first and second line drugs (tricyclic antidepressants, venlafaxine and gabapentinoids)
Who cannot join
- Don't full the criteria above
About this study
Neuropathic pain is a common condition and affecting 40 to 70% of the general population. Post-herpetic neuralgia is a condition almost complex and requires a multi modal treatment. Aim: This is a pilot proof-of-principle study designed to evaluate the use of low-dose methadone in post-herpetic neuralgia patients who remained refractory after first and second line treatment for post-herpetic neuralgia (PHN) and had indication for the association of an opioid agent to their current drug regimen.
- Conditions
- Post-herpetic Neuralgia
- Being tested
- Methadone, Placebo
- Keywords
- neuropathic pain,, post-herpetic neuralgia,, methadone,
- Medical subject headings
- Neuralgia, Postherpetic, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
patients with post-herpetic neuralgia take methadone or placebo to treat pain symptoms.
PlaceboDrug
patients with post-herpetic neuralgia take placebo to treat the pain symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Methadone | Experimental | in this arm patients will take methadone 5mg. Receives: Drug: Methadone |
| Placebo | Experimental | in this arm patients will take placebo pills. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline Pain
Assessing by verbal analog scale (VAS)
Measured: baseline (visit inclusion) and three moths latter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startJan 1998
- Primary completionFeb 2013
- Study completionMar 2013
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 Post-herpetic NeuralgiaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Ciampi Araujo de Andrade, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752699
- Sponsor's protocol ID
- NPH
- Acronym
- NPH
- Status last verified
- Mar 2013
- First submitted
- 11 Dec 2012
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Teixeira MJ, Okada M, Moscoso AS, Puerta MY, Yeng LT, Galhardoni R, Tengan S, Andrade DC. Methadone in post-herpetic neuralgia: A pilot proof-of-concept study. Clinics (Sao Paulo). 2013 Jul;68(7):1057-60. doi: 10.6061/clinics/2013(07)25.
PubMed 23917673
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methadone in Post-Herpetic Neuralgia Pain
- ClinicalTrials.gov ID
- NCT01752699
- Acronym / sponsor ID
- NPH / NPH
- Conditions
- Post-herpetic Neuralgia
- Keywords
- neuropathic pain,, post-herpetic neuralgia,, methadone,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 1998
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 19 Dec 2012 (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.
Neuropathic pain is a common condition and affecting 40 to 70% of the general population. Post-herpetic neuralgia is a condition almost complex and requires a multi modal treatment. Aim: This is a pilot proof-of-principle study designed to evaluate the use of low-dose methadone in post-herpetic neuralgia patients who remained refractory after first and second line treatment for post-herpetic neuralgia (PHN) and had indication for the association of an opioid agent to their current drug regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methadone | Experimental | Drug: Methadonein this arm patients will take methadone 5mg. |
| Placebo | Experimental | Drug: Placeboin this arm patients will take placebo pills. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with chronic (>6 months) symptomatic PHN
- with visual analogical scale >40/100mm
- use of first and second line drugs (tricyclic antidepressants, venlafaxine and gabapentinoids)
Key exclusion criteria (1 listed)
- Don't full the criteria above
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 |
|---|---|---|
| Methadonepatients with post-herpetic neuralgia take methadone or placebo to treat pain symptoms. | Drug | Methadone |
| Placebopatients with post-herpetic neuralgia take placebo to treat the pain symptoms. | Drug | Placebo |
Primary outcome
Change in baseline Pain
Time frame: baseline (visit inclusion) and three moths latter
Assessing by verbal analog scale (VAS)
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 18 Mar 2013.
- Derived from this study: PubMed 23917673Teixeira MJ, Okada M, Moscoso AS, Puerta MY, Yeng LT, Galhardoni R, Tengan S, Andrade DC. Methadone in post-herpetic neuralgia: A pilot proof-of-concept study. Clinics (Sao Paulo). 2013 Jul;68(7):1057-60. doi: 10.6061/clinics/2013(07)25.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methadone in people with Post-herpetic Neuralgia, run by University of Sao Paulo.
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 1 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 18 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
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 baseline Pain (time frame: baseline (visit inclusion) and three moths latter). 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 NCT01752699, 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 18 Mar 2013.