AzTrials
AzTrials

Neuralgia, PostherpeticPhase 3NCT00424372

A Long-Term Study To Evaluate Safety And Efficacy 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 33 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

To evaluate the safety of the long-term use of pregabalin. 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?
No, everyone receives an active treatment
How many people
126 participants
Where
33 sitesJapan
Study dates
12 Jan 2007to 19 Aug 2008
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

  • Patients who completed the 13-week treatment of postherpetic neuralgia in Study A0081120.
  • Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study.

Who cannot join

  • Patients who experienced serious adverse events in the preceding study (A0081120) that were determined by the investigator or the study sponsor to be causally related to the study medication.
  • Patients exhibiting treatment non-compliance in the preceding study (A0081120)

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

Japan33 sites

  • Seimei Clinic

    Akashi, Hyōgo, 673-0016

  • Uchida Pain Relief Clinic

    Amagasaki, Hyōgo, 661-0012

  • Tokyo Women's Medical University Center East

    Arakawa-ku, Tokyo, 116-8567

  • Asahikawa Pain Clinic Hospital

    Asahikawa, Hokkaido, 070-0034

  • Kamui Pain Clinic

    Asahikawa, Hokkaido, 070-8013

  • Nakamura Hospital

    Beppu, Ohita, 874-0937

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431

  • Mukai Clinic

    Fukuoka, 812-0011

  • KM Pain Clinic

    Fukuoka, 814-0001

  • Otsuki Sleep Clinic

    Fukushima, 960-8044

  • National Hospital Organization Himeji Medical Center

    Himeji, Hyōgo, 670-8520

  • Okabe Hospital

    Kasuya-gun, Fukuoka, 811-2122

  • Kawaguchi Kogyo General Hospital

    Kawaguchi, Saitama, 332-0031

  • National Hospital Organization Kobe Medical Center

    Kobe, Hyōgo, 654-0155

  • Nakamura Clinic

    Kobe, Hyōgo, 655-0854

  • Gunma Pain Clinic Hospital

    Maebashi, Gunma, 379-2147

  • Mitaka Pain Clinic

    Mitaka, Tokyo, 181-0013

  • National Hospital Organization Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001

  • Toriumi Pain Clinic

    Nakano-ku, Tokyo, 165-0027

  • National Hospital Organization Sagamihara National Hospital

    Sagamihara, Kanagawa, 228-8522

  • Hasumi Pain Clinic

    Saitama, 330-0805

  • Sapporo Asabu Clinic

    Sapporo, Hokkaido, 001-0045

  • Higashi Sapporo Hospital

    Sapporo, Hokkaido, 003-8585

  • Sendai Pain Clinic

    Sendai, Miyagi, 983-0036

  • Kanto Medical NTT East Corporation

    Shinagawa-ku, Tokyo, 141-0022

  • Naganuma Pain Clinic

    Shinagawa-ku, Tokyo, 141-0022

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, Tokyo, 162-8666

  • Takasaki Pain Clinic

    Takasaki, Gunma, 370-0035

  • Kinoshita Clinic

    Tokorozawa, Saitama, 359-0038

  • Kobayashi Clinic

    Urayasu, Chiba, 279-0012

  • Suzuki Pain Clinic

    Yokohama, Kanagawa, 227-0043

  • Hajiri Pain Clinic

    Yokohama, Kanagawa, 236-0037

  • National Hospital Organization Yokohama Medical Center

    Yokohama, Kanagawa, 245-8575

Other trials in Japan

About this study

Official title: A LONG-TERM STUDY TO EVALUATE SAFETY AND EFFICACY STUDY OF PREGABALIN IN THE TREATMENT OF POSTHERPETIC NEURALGIA.

To evaluate the safety of the long-term use of pregabalin.

Being tested
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.

  • pregabalinDrug

    Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks

Study groups in NCT00424372
Study groupRoleWhat they receive
pregabalinExperimentalNot described
Receives: Drug: pregabalin

What is being measured

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

  1. Summary of Adverse Events

    Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects are counted only once per treatment in each row.

    Measured: 52 weeks

Secondary outcomes (5)

  1. Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score

    Score ranges: 0-33. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.

    Measured: 52 weeks

  2. Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score

    Score ranges: 0-12. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.

    Measured: 52 weeks

  3. Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score

    Score ranges: 0-45. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.

    Measured: 52 weeks

  4. Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity

    Score ranges: 0-5. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.

    Measured: 52 weeks

  5. Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale

    Ranges: 0-100 mm. Larger scale indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.

    Measured: 52 weeks

Timeline

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

  1. First posted19 Jan 2007 (estimated)
  2. Study start12 Jan 2007
  3. Primary completion19 Aug 2008
  4. Study completion19 Aug 2008

Resources

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
Non-randomised
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00424372
Sponsor's protocol ID
A0081121
Status last verified
Jul 2021
First submitted
18 Jan 2007
Last updated
27 Aug 2021
Data monitoring committee
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Ogawa S, Arakawa A, Hayakawa K, Yoshiyama T. Pregabalin for Neuropathic Pain: Why Benefits Could Be Expected for Multiple Pain Conditions. Clin Drug Investig. 2016 Nov;36(11):877-888. doi: 10.1007/s40261-016-0423-x.

    PubMed 27448285

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 33 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 2 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 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 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. 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 28 Sep 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?

Summary of Adverse Events (time frame: 52 weeks). 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 NCT00424372, 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 27 Aug 2021; AzTrials last refreshed its copy on 30 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in