Nerve PainPhase 1NCT00654940

A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients

A Phase 1 study testing Pregabalin (Lyrica) in people with Nerve Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess whether a cross-over type study design in post-traumatic neuropathic patients can be used to assess the activity of potential analgesic agents Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Nerve Pain
What is being tested?: Pregabalin (Lyrica)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 25 participants
Where: 5 sitesin 2 countries
Study dates: May 2008to Feb 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients require a diagnosis of post-traumatic peripheral neuropathic pain (NeP), including post-surgical NeP and NeP due to peripheral nerve injury, which has lasted at least 3 months following the traumatic event.
Patients during the screening week must have completed ≥ 4 daily pain scores and have an average daily pain score ≥ 4.
Female patients of childbearing potential must have a negative urine pregnancy test at Screening and be practicing an acceptable form of contraception.

Who cannot join

Patients with neuropathic pain (NeP) that is not due to trauma; e.g. patients with trigeminal neuralgia, central pain, complex region pain syndrome type I, phantom limb pain, radiculopathy, painful diabetic neuropathy or post-herpetic neuralgia or patients with any other co-existing pain which cannot be differentiate from NeP of peripheral origin.
Patients who have previously failed to respond to pregabalin at a total daily dose of equal to or greater than 300 mg or are intolerant to those doses.
Patients who have previously failed to respond to gabapentin at a total daily dose of equal to or greater than 1800 mg.
Patients with any type or history of malignancy, except either where there has been no ongoing treatment for at least 6 months or all basal cell carcinomas; all patients with a history of brain or spinal tumors will be excluded.
Patients who currently have ongoing litigation related to any injury affecting their pain symptomatology.

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

Canada3 sites

Pfizer Investigational Site
Calgary, Alberta, T2N 4N1
Pfizer Investigational Site
Hamilton, Ontario, L8N 3Z5
Pfizer Investigational Site
Sarnia, Ontario, N7T 4X3

Other trials in Canada

Sweden2 sites

Pfizer Investigational Site
Jönköping, 551 85
Pfizer Investigational Site
Linköping, 581 85

Other trials in Sweden

About this study

Official title: Methodology Study To Assess The Ability Of A Randomized, Double-Blind, Placebo-Controlled, Two Period Crossover Study To Detect The Effect Of Pregabalin In Post-Traumatic Neuropathic Pain Patients

The purpose of this study is to assess whether a cross-over type study design in post-traumatic neuropathic patients can be used to assess the activity of potential analgesic agents

Read the detailed description

Methodology study to evaluate a cross-over study design in post-traumatic neuropathic pain patients.

Conditions: Nerve Pain
Being tested: Pregabalin (Lyrica), Placebo
Medical subject headings: Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pregabalin (Lyrica)Drug
Oral, 75mg or 150mg capsules, BID
PlaceboDrug
Oral, matched capsules, BID

Study groups in NCT00654940
Study group	Role	What they receive
A	Active comparator	Not described Receives: Drug: Pregabalin (Lyrica)
B	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale
Daily Pain Rating Scale by treatment and sequence using an 11-point Likert scale: range 0 (no pain) to 10 (worst possible pain) over the past 24 hours. Self-assessment was performed daily on rising from bed (for the final time in the case of interrupted sleep). Average daily pain score: mean of the previous 7 days daily pain scores. Baseline was defined as the mean of the last 7 pre-treatment pain scores for each period. End of treatment was defined as the mean of the last 7 on treatment pain scores for each period.
Measured: Week 0 to Week 2, Week 4 to Week 6 (Baseline to Week 2 [End of Treatment] for each treatment period)

Secondary outcomes (2)

Neuropathic Pain Symptom Inventory (NPSI)
NPSI at end of treatment: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia). Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain. Maximum total score possible = 100.
Measured: Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2)
Subject Activity as Captured by the Actiwatch Score Device: Total Activity Score at End of Treatment
Total activity score: Day (8 am to 8 pm) at end of treatment. Accelerometer measured physical activity by monitoring degree and intensity of body motion. Data is reported as activity counts. Subject activity was collected hourly for the variables: peak, average, and total activity. Higher score indicates greater activity (no activity = 0; total possible score was not defined).
Measured: Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Feb 2009

First posted9 Apr 2008 (estimated)
Study startMay 2008
Primary completionFeb 2009
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Nerve PainStudies 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 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00654940
Sponsor's protocol ID: A0081187
Status last verified: Feb 2010
First submitted: 3 Apr 2008
Last updated: 9 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Nerve Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Methodology Study To Assess The Ability Of A Randomized, Double-Blind, Placebo-Controlled, Two Period Crossover Study To Detect The Effect Of Pregabalin In Post-Traumatic Neuropathic Pain Patients
ClinicalTrials.gov ID: NCT00654940
Acronym / sponsor ID: A0081187
Conditions: Nerve Pain
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 9 Apr 2008 (estimated)
Results: Posted 24 Feb 2010

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 whether a cross-over type study design in post-traumatic neuropathic patients can be used to assess the activity of potential analgesic agents

Detailed description

Methodology study to evaluate a cross-over study design in post-traumatic neuropathic pain patients.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
A	Active comparator	Drug: Pregabalin (Lyrica)
B	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients require a diagnosis of post-traumatic peripheral neuropathic pain (NeP), including post-surgical NeP and NeP due to peripheral nerve injury, which has lasted at least 3 months following the traumatic event.
Patients during the screening week must have completed ≥ 4 daily pain scores and have an average daily pain score ≥ 4.
Female patients of childbearing potential must have a negative urine pregnancy test at Screening and be practicing an acceptable form of contraception.

Key exclusion criteria (5 listed)

Patients with neuropathic pain (NeP) that is not due to trauma; e.g. patients with trigeminal neuralgia, central pain, complex region pain syndrome type I, phantom limb pain, radiculopathy, painful diabetic neuropathy or post-herpetic neuralgia or patients with any other co-existing pain which cannot be differentiate from NeP of peripheral origin.
Patients who have previously failed to respond to pregabalin at a total daily dose of equal to or greater than 300 mg or are intolerant to those doses.
Patients who have previously failed to respond to gabapentin at a total daily dose of equal to or greater than 1800 mg.
Patients with any type or history of malignancy, except either where there has been no ongoing treatment for at least 6 months or all basal cell carcinomas; all patients with a history of brain or spinal tumors will be excluded.
Patients who currently have ongoing litigation related to any injury affecting their pain symptomatology.

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
Pregabalin (Lyrica)Oral, 75mg or 150mg capsules, BID	Drug	A
PlaceboOral, matched capsules, BID	Drug	B

Primary outcome

Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale
Time frame: Week 0 to Week 2, Week 4 to Week 6 (Baseline to Week 2 [End of Treatment] for each treatment period)
Daily Pain Rating Scale by treatment and sequence using an 11-point Likert scale: range 0 (no pain) to 10 (worst possible pain) over the past 24 hours. Self-assessment was performed daily on rising from bed (for the final time in the case of interrupted sleep). Average daily pain score: mean of the previous 7 days daily pain scores. Baseline was defined as the mean of the last 7 pre-treatment pain scores for each period. End of treatment was defined as the mean of the last 7 on treatment pain scores for each period.

2 secondary outcomes

Neuropathic Pain Symptom Inventory (NPSI)
Time frame: Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2)
Subject Activity as Captured by the Actiwatch Score Device: Total Activity Score at End of Treatment
Time frame: Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2)

Results and safety

Results posted to the registry on 24 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pregabalin First Then Placebo	13	12
Placebo First Then Pregabalin	12	11

Primary outcome: Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale

Time frame: Week 0 to Week 2, Week 4 to Week 6 (Baseline to Week 2 [End of Treatment] for each treatment period). Mean (Standard Deviation). Unit: scores on scale

Measure	Period 1: Pregabalin n = 13	Period 1: Placebo n = 12	Period 2: Placebo n = 12	Period 2: Pregabalin n = 11
Baseline	6.03 (1.29)	5.24 (2.03)	5.96 (0.88)	5.31 (1.82)
Treatment Week 2	5.40 (1.34)	5.08 (2.05)	6.11 (1.20)	4.38 (2.02)
Change from Baseline	-0.63 (1.01)	-0.16 (0.97)	0.16 (1.07)	-0.93 (1.24)

Period 1: Pregabalin vs Period 1: Placebo vs Period 2: Placebo vs Period 2: Pregabalin: Mean Difference (Final Values): -0.81 (80% CI -1.21 to -0.41), ANCOVA

Population analysed: Full Analysis Set: (FAS): all subjects randomized who received at least one dose of study drug, regardless of whether they had efficacy data. Baseline is Week 0 and Week 4 for Periods 1 and 2, respectively. Treatment Week 2 is End of Treatment (Week 2 and Week 6) for Periods 1 and 2, respectively.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin	0 of 24 (0%)	11 of 24 (45.8%)	Not reported
Placebo	0 of 24 (0%)	10 of 24 (41.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Nerve Pain

Recruiting
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Enrolling by invitation
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RecruitingPhase 2
Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
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Recruiting
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Not yet recruiting
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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

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pregabalin (Lyrica) in people with Nerve Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 5 sites in 2 countries.

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 5 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 9 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 5 sites in Canada, Sweden. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 From Baseline to Treatment Week 2 in Daily Pain Rating Scale (time frame: Week 0 to Week 2, Week 4 to Week 6 (Baseline to Week 2 [End of Treatment] for each treatment period)). 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 NCT00654940.

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 9 Feb 2021; AzTrials last refreshed its copy on 1 Nov 2026.