Neuralgia, PostherpeticPhase 3NCT00394901

A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia

A Phase 3 study testing Pregabalin in people with Neuralgia, Postherpetic, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 39 sites in Japan.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate efficacy and safety of pregabalin in the treatment of postherpetic neuralgia in a dose-ranging manner. 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?: Pregabalin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 372 participants
Where: 39 sitesJapan
Study dates: Sep 2006to Nov 2007
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Visual Analogue Scale (VAS) of pain is higher than 40 mm.
Pain is sustained for more than 3 months after healing of herpes zoster skin rash.

Who cannot join

Malignancy within the past 2 years.
Patients who have undergone neurolytic or neurosurgical therapy for postherpetic neuralgia.
Creatinine clearance </= 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation, by omitting any decimal fractions).
Patients having other severe pain which may impair the self assessment of the pain due to postherpetic neuralgia.
Skin conditions in the affected dermatome that could alter sensation.

Trial locations and contacts

39 sites in 1 country.

City, postcode or hospital

39 sites in 1 country

Japan39 sites

Pfizer Investigational Site
Adachi-ku, Tokyo
Pfizer Investigational Site
Akashi, Hyōgo
Pfizer Investigational Site
Amagasaki, Hyōgo
Pfizer Investigational Site
Arakawa-ku, Tokyo
Pfizer Investigational Site
Asahikawa, Hokkaido
Pfizer Investigational Site
Beppu, Ohita
Pfizer Investigational Site
Bunkyo-ku, Tokyo
Pfizer Investigational Site
Edogawa-ku, Tokyo
Pfizer Investigational Site
Fukuoka
Pfizer Investigational Site
Fukushima
Pfizer Investigational Site
Himeji, Hyōgo
Pfizer Investigational Site
Ichikawa, Chiba
Pfizer Investigational Site
Kasuga, Fukuoka
Pfizer Investigational Site
Kasuya-gun, Fukuoka
Pfizer Investigational Site
Kawaguchi, Saitama
Pfizer Investigational Site
Kishiwada, Osaka
Pfizer Investigational Site
Kitamoto, Saitama
Pfizer Investigational Site
Kobe, Hyōgo
Pfizer Investigational Site
Maebaru-chūō, Fukuoka
Pfizer Investigational Site
Maebashi, Gunma
Pfizer Investigational Site
Mitaka, Tokyo
Pfizer Investigational Site
Nagoya, Aichi-ken
Pfizer Investigational Site
Nakano-ku, Tokyo
Pfizer Investigational Site
Nishinomiya, Hyōgo
Pfizer Investigational Site
Osaka
Pfizer Investigational Site
Sagamihara, Kanagawa
Pfizer Investigational Site
Saitama
Pfizer Investigational Site
Sapporo, Hokkaido
Pfizer Investigational Site
Sendai, Miyagi
Pfizer Investigational Site
Shinagawa-ku, Tokyo
Pfizer Investigational Site
Shinjuku-ku, Tokyo
Pfizer Investigational Site
Suginami-ku, Tokyo
Pfizer Investigational Site
Takasaki, Gunma
Pfizer Investigational Site
Takatsuki, Osaka
Pfizer Investigational Site
Tokorozawa, Saitama
Pfizer Investigational Site
Toshima-ku, Tokyo
Pfizer Investigational Site
Tsuchiura, Ibaraki
Pfizer Investigational Site
Urayasu, Chiba
Pfizer Investigational Site
Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin In The Treatment Of Postherpetic Neuralgia

The purpose of this study is to evaluate efficacy and safety of pregabalin in the treatment of postherpetic neuralgia in a dose-ranging manner.

Conditions: Neuralgia, Postherpetic
Being tested: Placebo, Pregabalin
Medical subject headings: Neuralgia, Postherpetic

What participants receive

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

PlaceboDrug
placebo, oral administration for 13 weeks (1 week titration and 12-week fixed dose).
PregabalinDrug
Pregabalin 150mg/day (75mg BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
PregabalinDrug
Pregabalin 300mg/day (150mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
PregabalinDrug
Pregabalin 600 mg/day (300 mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).

Study groups in NCT00394901
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Pregabalin 150mg/day	Experimental	Not described Receives: Drug: Pregabalin
Pregabalin 300mg/day	Experimental	Not described Receives: Drug: Pregabalin
Pregabalin 600mg/day	Experimental	Not described Receives: Drug: Pregabalin

What is being measured

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

Mean Pain Scores at Endpoint
Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.
Measured: Week13/discontinuation
Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations
Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.
Measured: Week13/discontinuation
Number of Responders
A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to endpoint.
Measured: Week13/discontinuation
Mean Pain Scores at Week 1
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Measured: Week 1
Mean Pain Scores at Week 2
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Measured: Week 2
Mean Pain Scores at Week 3
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Measured: Week 3
Mean Pain Scores at Week 4
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Measured: Week4
Mean Pain Scores at Week 5
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Measured: Week 5
Mean Pain Scores at Week 6
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Measured: Week 6
Mean Pain Scores at Week 7
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Measured: Week 7
Mean Pain Scores at Week 8
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Measured: Week 8
Mean Pain Scores at Week 9
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Measured: Week 9
Mean Pain Scores at Week 10
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Measured: Week 10
Mean Pain Scores at Week 11
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Measured: Week 11
Mean Pain Scores at Week 12
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Measured: Week 12
Mean Pain Scores at Week 13
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Measured: Week 13

Secondary outcomes (39)

Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire
Sensory score range from 0-33. Higher scores indicate more severe pain.
Measured: Week13/discontinuation
Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire
Affective score range from 0-12. Higher scores indicate more severe pain.
Measured: Week13/discontinuation
Endpoint Total Scores of the Short-Form McGill Pain Questionnaire
Total score range from 0-45. Higher scores indicate more severe pain.
Measured: Week13/discontinuation
Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire
Visual Analogue Scale Score range from 0-100mm. Higher scores indicate more severe pain.
Measured: Week13/discontinuation
Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire
Present pain intensity score range from 0-5. Higher scores indicate more severe pain.
Measured: Week13/discontinuation
Mean Sleep Interference Scores at Endpoint
Scores range from 0-10. Higher scores indicate more severe interference with sleep.
Measured: Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance
Score range for sleep disturbance is 0-100.Higher scores indicate more of the attribute.
Measured: Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring
Score range for snoring is 0-100.Higher scores indicate more of the attribute.
Measured: Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache
Score range for awaken short of breath or with headache is 0-100. Higher scores indicate more of the attribute.
Measured: Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep
Sleep Quantity subscale is scored from 0-24 indicating the number of hours of sleep. Higher scores indicate more of the attribute named in the subscale.
Measured: Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy
Score range for sleep adequacy is 0-100. Higher scores indicate more of the attribute.
Measured: Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence
Score range for Somnolence is 0-100. Higher scores indicate more of the attribute.
Measured: Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index
Score range for overall sleep problem index is 0-100. Higher scores indicate more of the attribute.
Measured: Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep
Number of participants who reported Optimal Sleep
Measured: Week13/discontinuation
Endpoint Patient Global Impression Change
Patient Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.
Measured: Week13/discontinuation
Endpoint Clinical Global Impression Change
Clinical Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.
Measured: Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Measured: Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Measured: Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Measured: Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Measured: Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Measured: Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Measured: Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: Vitality
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Measured: Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: Mental Health
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Measured: Week13/discontinuation
Number of Patients Not Reporting Allodynia
Participants not reporting allodynia.
Measured: Week13/discontinuation
Number of Patients Not Reporting Hyperalgesia
Participants not reporting hyperalgesia.
Measured: Week13/discontinuation
Mean Sleep Interference Scores at Week 1
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Measured: week 1
Mean Sleep Interference Scores at Week 2
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Measured: week 2
Mean Sleep Interference Scores at Week 3
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Measured: week 3
Mean Sleep Interference Scores at Week 4
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Measured: week 4
Mean Sleep Interference Scores at Week 5
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Measured: week 5
Mean Sleep Interference Scores at Week 6
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Measured: week 6
Mean Sleep Interference Scores at Week 7
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Measured: week 7
Mean Sleep Interference Scores at Week 8
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Measured: week 8
Mean Sleep Interference Scores at Week 9
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Measured: week 9
Mean Sleep Interference Scores at Week 10
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Measured: week 10
Mean Sleep Interference Scores at Week 11
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Measured: week 11
Mean Sleep Interference Scores at Week 12
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Measured: week 12
Mean Sleep Interference Scores at Week 13
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Measured: week 13

Timeline

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

Sep 2006Nov 2007

First posted2 Nov 2006 (estimated)
Study startSep 2006
Primary completionNov 2007
Study completionNov 2007

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 Neuralgia, PostherpeticStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 372 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00394901
Sponsor's protocol ID: A0081120
Status last verified: Feb 2010
First submitted: 31 Oct 2006
Last updated: 9 Feb 2021
Results posted: Yes, on ClinicalTrials.gov

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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Herpes Zoster, Pain
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Efficacy and Safety of Intravenous Dexamethasone Palmitate Treatments in Acute and Subacute Herpes Zoster Pain
Herpes Zoster Pain
RecruitingPhase 2
A Clinical Trial to Evaluate the Efficacy and Safety of HL-1186 Tablet in the Treatment of Postherpetic Neuralgia
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All Neuralgia, Postherpetic 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: A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin In The Treatment Of Postherpetic Neuralgia
ClinicalTrials.gov ID: NCT00394901
Acronym / sponsor ID: A0081120
Conditions: Neuralgia, Postherpetic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 372 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Nov 2007 (actual)
Study completion: Nov 2007 (actual)
First posted: 2 Nov 2006 (estimated)
Results: Posted 27 Feb 2009

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 evaluate efficacy and safety of pregabalin in the treatment of postherpetic neuralgia in a dose-ranging manner.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
Pregabalin 150mg/day	Experimental	Drug: Pregabalin
Pregabalin 300mg/day	Experimental	Drug: Pregabalin
Pregabalin 600mg/day	Experimental	Drug: Pregabalin

Who may qualify

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

Key inclusion criteria (2 listed)

Visual Analogue Scale (VAS) of pain is higher than 40 mm.
Pain is sustained for more than 3 months after healing of herpes zoster skin rash.

Key exclusion criteria (5 listed)

Malignancy within the past 2 years.
Patients who have undergone neurolytic or neurosurgical therapy for postherpetic neuralgia.
Creatinine clearance </= 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation, by omitting any decimal fractions).
Patients having other severe pain which may impair the self assessment of the pain due to postherpetic neuralgia.
Skin conditions in the affected dermatome that could alter sensation.

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
Placeboplacebo, oral administration for 13 weeks (1 week titration and 12-week fixed dose).	Drug	Placebo
PregabalinPregabalin 150mg/day (75mg BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).	Drug	Pregabalin 150mg/day
PregabalinPregabalin 300mg/day (150mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).	Drug	Pregabalin 300mg/day
PregabalinPregabalin 600 mg/day (300 mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).	Drug	Pregabalin 600mg/day

Primary outcome

Mean Pain Scores at Endpoint
Time frame: Week13/discontinuation
Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.
Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations
Time frame: Week13/discontinuation
Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.
Number of Responders
Time frame: Week13/discontinuation
A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to endpoint.
Mean Pain Scores at Week 1
Time frame: Week 1
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 2
Time frame: Week 2
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 3
Time frame: Week 3
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 4
Time frame: Week4
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 5
Time frame: Week 5
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 6
Time frame: Week 6
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 7
Time frame: Week 7
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 8
Time frame: Week 8
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 9
Time frame: Week 9
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 10
Time frame: Week 10
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 11
Time frame: Week 11
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 12
Time frame: Week 12
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 13
Time frame: Week 13
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

39 secondary outcomes

Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire
Time frame: Week13/discontinuation
Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire
Time frame: Week13/discontinuation
Endpoint Total Scores of the Short-Form McGill Pain Questionnaire
Time frame: Week13/discontinuation
Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire
Time frame: Week13/discontinuation
Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire
Time frame: Week13/discontinuation
Mean Sleep Interference Scores at Endpoint
Time frame: Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance
Time frame: Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring
Time frame: Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache
Time frame: Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep
Time frame: Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy
Time frame: Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence
Time frame: Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index
Time frame: Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep
Time frame: Week13/discontinuation
Endpoint Patient Global Impression Change
Time frame: Week13/discontinuation
Endpoint Clinical Global Impression Change
Time frame: Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning
Time frame: Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical
Time frame: Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain
Time frame: Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception
Time frame: Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning
Time frame: Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional
Time frame: Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: Vitality
Time frame: Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: Mental Health
Time frame: Week13/discontinuation
Number of Patients Not Reporting Allodynia
Time frame: Week13/discontinuation
Number of Patients Not Reporting Hyperalgesia
Time frame: Week13/discontinuation
Mean Sleep Interference Scores at Week 1
Time frame: week 1
Mean Sleep Interference Scores at Week 2
Time frame: week 2
Mean Sleep Interference Scores at Week 3
Time frame: week 3
Mean Sleep Interference Scores at Week 4
Time frame: week 4
Mean Sleep Interference Scores at Week 5
Time frame: week 5
Mean Sleep Interference Scores at Week 6
Time frame: week 6
Mean Sleep Interference Scores at Week 7
Time frame: week 7
Mean Sleep Interference Scores at Week 8
Time frame: week 8
Mean Sleep Interference Scores at Week 9
Time frame: week 9
Mean Sleep Interference Scores at Week 10
Time frame: week 10
Mean Sleep Interference Scores at Week 11
Time frame: week 11
Mean Sleep Interference Scores at Week 12
Time frame: week 12
Mean Sleep Interference Scores at Week 13
Time frame: week 13

Results and safety

Results posted to the registry on 27 Feb 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	98	98
Pregabalin 150 mg/Day	87	87
Pregabalin 300 mg/Day	90	89
Pregabalin 600 mg/Day	97	97

Primary outcome: Mean Pain Scores at Endpoint

Time frame: Week13/discontinuation. Least squares mean (Standard Error). Unit: score on scale

Measure	Placebo n = 97	Pregabalin 150 mg/Day n = 86	Pregabalin 300 mg/Day n = 89	Pregabalin 600 mg/Day n = 97
Value	5.12 (0.19)	4.81 (0.20)	4.26 (0.20)	4.49 (0.19)

Placebo vs Pregabalin 150 mg/Day: Mean Difference (Final Values): -0.31 (95% CI -0.85 to 0.23), p = 0.262, ANCOVA
Placebo vs Pregabalin 300 mg/Day: Mean Difference (Final Values): -0.86 (95% CI -1.39 to -0.32), p = 0.002, ANCOVA
Placebo vs Pregabalin 600 mg/Day: Mean Difference (Final Values): -0.63 (95% CI -1.15 to -0.10), p = 0.019, ANCOVA

Population analysed: Full analysis set. Last observation carried forward.

Primary outcome: Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations

Time frame: Week13/discontinuation. Least squares mean (Standard Error). Unit: score on scale

Measure	Placebo n = 97	Expected Pregabalin Exposure of 300 mg/Day n = 92	Expected Pregabalin Exposure of 600 mg/Day n = 122
Value	4.99 (0.18)	4.35 (0.19)	4.34 (0.16)

Placebo vs Expected Pregabalin Exposure of 300 mg/Day: Mean Difference (Final Values): -0.64 (95% CI -1.16 to -0.12), p = 0.016, ANCOVA
Placebo vs Expected Pregabalin Exposure of 600 mg/Day: Mean Difference (Final Values): -0.66 (95% CI -1.14 to -0.17), p = 0.008, ANCOVA

Population analysed: Full analysis set. Last observation carried forward.

Primary outcome: Number of Responders

Time frame: Week13/discontinuation. Number. Unit: participants

Measure	Placebo n = 97	Pregabalin 150 mg/Day n = 86	Pregabalin 300 mg/Day n = 89	Pregabalin 600 mg/Day n = 97
Value	15	21	32	30

Placebo vs Pregabalin 150 mg/Day: p = 0.1160, Cochran-Mantel-Haenszel
Placebo vs Pregabalin 300 mg/Day: p = 0.0015, Cochran-Mantel-Haenszel
Placebo vs Pregabalin 600 mg/Day: p = 0.0107, Cochran-Mantel-Haenszel

Population analysed: Full analysis set. Last observation carried forward.

Primary outcome: Mean Pain Scores at Week 1

Time frame: Week 1. Least squares mean (Standard Error). Unit: score on scale

Measure	Placebo n = 97	Pregabalin 150 mg/Day n = 86	Pregabalin 300 mg/Day n = 89	Pregabalin 600 mg/Day n = 97
Value	5.96 (0.17)	5.45 (0.18)	5.21 (0.18)	5.23 (0.17)

Placebo vs Pregabalin 150 mg/Day: Mean Difference (Final Values): -0.51 (95% CI -0.99 to -0.03), p = 0.038, repeated measures analysis
Placebo vs Pregabalin 300 mg/Day: Mean Difference (Final Values): -0.75 (95% CI -1.22 to -0.27), p = 0.002, repeated measures analysis
Placebo vs Pregabalin 600 mg/Day: Mean Difference (Final Values): -0.72 (95% CI -1.19 to -0.26), p = 0.002, repeated measures analysis

Population analysed: Full analysis set. Observed case.

39 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	6 of 98 (6.1%)	35 of 98 (35.7%)	Not reported
Pregabalin 150 mg/Day	2 of 87 (2.3%)	44 of 87 (50.6%)	Not reported
Pregabalin 300 mg/Day	4 of 89 (4.5%)	61 of 89 (68.5%)	Not reported
Pregabalin 600 mg/Day	1 of 97 (1%)	77 of 97 (79.4%)	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.

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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

39 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 Pregabalin in people with Neuralgia, Postherpetic, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 39 sites in Japan.

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 2 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 39 sites in Japan. 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 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?

Yes. Results are posted in the registry (first posted 27 Feb 2009). 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?

Mean Pain Scores at Endpoint (time frame: Week13/discontinuation). The study lists 16 primary outcomes in all. 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 NCT00394901.

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.