NeuralgiaNCT00674687
A Study Of The Efficacy Of Gabapentin In Neuropathic Pain Patients As Measured By Quantitative Sensory Testing
A study of Neuralgia and Neuralgia, Postherpetic, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the reproducibility and the effect of gabapentin on quantitative sensory testing assessments in neuropathic pain subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuralgia, Neuralgia, Postherpetic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2004to Jun 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neuropathic pain of peripheral origin as a consequence of either post-herpetic neuralgia or post-traumatic neuropathic pain
- Well-defined skin area of mechanical allodynia to punctate (von Frey filament) stimuli
- Pain intensity score of ≥ 4/10 for von Frey filament-evoked allodynia at the skin area
Who cannot join
- Patients who have undergone neurolytic or neurosurgical therapy, including skin excisions, for neuropathic pain
- Patients who have trigeminal neuralgia, central pain, chronic radiculopathy, or peripheral neuropathy of non-mechanical or unknown origin
- Patients with any other co-existing pain which cannot be differentiated from the neuropathic pain of peripheral origin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double-Blind, Placebo-Controlled, Crossover Study To Assess The Reproducibility And The Effect Of Gabapentin On Quantitative Sensory Testing In Neuropathic Pain Patients
The purpose of this study is to assess the reproducibility and the effect of gabapentin on quantitative sensory testing assessments in neuropathic pain subjects.
- Conditions
- Neuralgia, Neuralgia, Postherpetic
- Being tested
- 2-weeks placebo then gabapentin, 1-week placebo then gabapentin
- Medical subject headings
- Neuralgia, Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-weeks placebo then gabapentinDrug
Placebo for 2 weeks followed by gabapentin 300 mg oral capsule once daily titrated over 1 week to gabapentin 600 mg three times daily for 1 week
1-week placebo then gabapentinDrug
Placebo for 1 week followed by gabapentin 300 mg oral capsule once daily titrated over 1 week to gabapentin 600 mg three times daily for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Placebo comparator | Not described Receives: Drug: 2-weeks placebo then gabapentin |
| Sequence 2 | Experimental | Not described Receives: Drug: 1-week placebo then gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/intensity of punctate allodynia (von Frey filament), measured on the pain numeric rating scale (NRS)
Measured: Weeks 2 and 4
Secondary outcomes (21)
Subject assessed quality of evoked pain for punctate allodynia
Measured: Weeks 2 and 4
Pain NRS score for temporal summation to dynamic brush allodynia (soft and coarse brush)
Measured: Weeks 2 and 4
Pressure pain tolerance threshold
Measured: Weeks 2 and 4
Pain NRS scores for pressure pain
Measured: Weeks 2 and 4
Subject assessed quality of evoked pain for temporal summation to dynamic brush allodynia (soft and coarse brush)
Measured: Weeks 2 and 4
Tactile threshold
Measured: Week 4
Pressure pain detection threshold
Measured: Weeks 2 and 4
Area of punctate and dynamic (soft and coarse brush) allodynia
Measured: Weeks 2 and 4
Pain NRS score for punctate allodynia
Measured: Weeks 2 and 4
Pain NRS scores for temporal summation to punctate stimuli
Measured: Weeks 2 and 4
Subject assessed quality of evoked pain for temporal summation to punctate stimuli
Measured: Weeks 2 and 4
Neuropathic pain scale
Measured: Week 4
Test-day global pain scale
Measured: Week 4
Pain diary card
Measured: Week 4
Pain NRS score for dynamic brush allodynia (soft brush)
Measured: Weeks 2 and 4
Subject assessed quality of evoked pain for dynamic brush allodynia (soft brush)
Measured: Weeks 2 and 4
Presence of metabonomic biomarkers
Measured: Weeks 1 and 4
Physical examination
Measured: 1 week after 4-week treatment period
Adverse events
Measured: Throughout study duration
Clinical laboratory tests
Measured: 1 week after 4-week treatment period
Subject assessed quality of pressure pain
Measured: Weeks 2 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startJul 2004
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuralgiaStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674687
- Sponsor's protocol ID
- A9451138
- Status last verified
- May 2008
- First submitted
- 6 May 2008
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind, Placebo-Controlled, Crossover Study To Assess The Reproducibility And The Effect Of Gabapentin On Quantitative Sensory Testing In Neuropathic Pain Patients
- ClinicalTrials.gov ID
- NCT00674687
- Acronym / sponsor ID
- A9451138
- Conditions
- Neuralgia, Neuralgia, Postherpetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- Jun 2006 (actual)
- First posted
- 8 May 2008 (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 purpose of this study is to assess the reproducibility and the effect of gabapentin on quantitative sensory testing assessments in neuropathic pain subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Placebo comparator | Drug: 2-weeks placebo then gabapentin |
| Sequence 2 | Experimental | Drug: 1-week placebo then gabapentin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Neuropathic pain of peripheral origin as a consequence of either post-herpetic neuralgia or post-traumatic neuropathic pain
- Well-defined skin area of mechanical allodynia to punctate (von Frey filament) stimuli
- Pain intensity score of ≥ 4/10 for von Frey filament-evoked allodynia at the skin area
Key exclusion criteria (3 listed)
- Patients who have undergone neurolytic or neurosurgical therapy, including skin excisions, for neuropathic pain
- Patients who have trigeminal neuralgia, central pain, chronic radiculopathy, or peripheral neuropathy of non-mechanical or unknown origin
- Patients with any other co-existing pain which cannot be differentiated from the neuropathic pain of peripheral origin
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 |
|---|---|---|
| 2-weeks placebo then gabapentinPlacebo for 2 weeks followed by gabapentin 300 mg oral capsule once daily titrated over 1 week to gabapentin 600 mg three times daily for 1 week | Drug | Sequence 1 |
| 1-week placebo then gabapentinPlacebo for 1 week followed by gabapentin 300 mg oral capsule once daily titrated over 1 week to gabapentin 600 mg three times daily for 2 weeks | Drug | Sequence 2 |
Primary outcome
Presence/intensity of punctate allodynia (von Frey filament), measured on the pain numeric rating scale (NRS)
Time frame: Weeks 2 and 4
21 secondary outcomes
Subject assessed quality of evoked pain for punctate allodynia
Time frame: Weeks 2 and 4
Pain NRS score for temporal summation to dynamic brush allodynia (soft and coarse brush)
Time frame: Weeks 2 and 4
Pressure pain tolerance threshold
Time frame: Weeks 2 and 4
Pain NRS scores for pressure pain
Time frame: Weeks 2 and 4
Subject assessed quality of evoked pain for temporal summation to dynamic brush allodynia (soft and coarse brush)
Time frame: Weeks 2 and 4
Tactile threshold
Time frame: Week 4
Pressure pain detection threshold
Time frame: Weeks 2 and 4
Area of punctate and dynamic (soft and coarse brush) allodynia
Time frame: Weeks 2 and 4
Pain NRS score for punctate allodynia
Time frame: Weeks 2 and 4
Pain NRS scores for temporal summation to punctate stimuli
Time frame: Weeks 2 and 4
Subject assessed quality of evoked pain for temporal summation to punctate stimuli
Time frame: Weeks 2 and 4
Neuropathic pain scale
Time frame: Week 4
Test-day global pain scale
Time frame: Week 4
Pain diary card
Time frame: Week 4
Pain NRS score for dynamic brush allodynia (soft brush)
Time frame: Weeks 2 and 4
Subject assessed quality of evoked pain for dynamic brush allodynia (soft brush)
Time frame: Weeks 2 and 4
Presence of metabonomic biomarkers
Time frame: Weeks 1 and 4
Physical examination
Time frame: 1 week after 4-week treatment period
Adverse events
Time frame: Throughout study duration
Clinical laboratory tests
Time frame: 1 week after 4-week treatment period
Subject assessed quality of pressure pain
Time frame: Weeks 2 and 4
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 2 Feb 2021.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Neuralgia and Neuralgia, Postherpetic, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in United Kingdom.
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 3 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 2 Feb 2021. 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 United Kingdom. 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?
Presence/intensity of punctate allodynia (von Frey filament), measured on the pain numeric rating scale (NRS) (time frame: Weeks 2 and 4). 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 2 Feb 2021.