AzTrials
AzTrials

Postherpetic NeuralgiaPhase 2NCT00599638

A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia

A Phase 2 study testing pregabalin and pregabalin/PF-00489791 in people with Postherpetic Neuralgia, run by Pfizer at 39 sites in United States.

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

Pregabalin is an alpha-2 delta ligand approved for the treatment of neuropathic pain, however, not all patients will respond to this drug. This study will compare the efficacy of pregabalin when administered with an experimental drug PF-00489791, in patients with post-herpetic neuralgia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postherpetic Neuralgia
What is being tested?
pregabalin and pregabalin/PF-00489791
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
39 sitesUnited States
Study dates
9 Apr 2008to 23 Dec 2008
Phase
Phase 2
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

  • Male or female of non-childbearing potential
  • Pain present for more than 3 months after healing of herpes zoster skin rash
  • VAS score of >=40mm at screening and baseline visits

Who cannot join

  • Patients with pain conditions which might impair the assessment of postherpetic neuralgia
  • Skin conditions in the affected dermatome that could alter sensation other than postherpetic neuralgia
  • History or diagnosis of DSM IV major depressive disorder

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • Medical Clinic of North Texas

    Arlington, Texas, 76012

  • FutureSearch Trials of Neurology

    Austin, Texas, 78756

  • Futuresearch Trials

    Austin, Texas, 78756

  • Legacy Pharma Research

    Bismarck, North Dakota, 58501

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida, 33486

  • Bradenton Research Center

    Bradenton, Florida, 34205

  • Beacon Clinical Research

    Brockton, Massachusetts, 02301

  • Radiant Research

    Chandler, Arizona, 85225

  • Patient Priority Clinical Sites, LLC

    Cincinnati, Ohio, 45242

  • Community Medical Providers

    Clovis, California, 93611

  • Absolute Primary Care, P.C.

    Cranberry Twp., Pennsylvania, 16066

  • New England Center for Clinical Research

    Cranston, Rhode Island, 02920

  • Pinnacle Pain Medicine

    Dallas, Texas, 75231

  • Arthritis Associates of South Florida

    Delray Beach, Florida, 33484

  • Delray Research Associates

    Delray Beach, Florida, 33484

  • The Medical Group Of Texas

    Fort Worth, Texas, 76104

  • Sierra Medical Research (Administrative only site)

    Fresno, California, 93710

  • Neurological Research Center at Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401-7246

  • North Alabama RadioPharmacy

    Huntsville, Alabama, 35801

  • Tennessee Valley Pain Consultants

    Huntsville, Alabama, 35801

  • Medical and Surgical Clinic of Irving

    Irving, Texas, 75061

  • CRC of Jackson

    Jackson, Mississippi, 39202

  • Physician's Surgery Center

    Jackson, Mississippi, 39202

  • John P. Murtha Neuroscience and Pain Institute

    Johnstown, Pennsylvania, 15904

  • Memorial Medical Center

    Johnstown, Pennsylvania, 15905

  • North State Clinical Research, PLLC

    Lenoir, North Carolina, 28645

  • Novara Clinical Research

    Mesa, Arizona, 85206

  • Prime-Care Clinical Research

    Mission Viejo, California, 92691

  • Centennial Park Medical Building

    North Platte, Nebraska, 69101

  • Neurology Associates of Great Plains

    North Platte, Nebraska, 69101

  • ICPS Group

    Norwood, Massachusetts, 02062

  • American Medical Research, Inc.

    Oak Brook, Illinois, 60523

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Mark A. Fisher, MD-Private Practice

    Oklahoma City, Oklahoma, 73112

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

  • Clinvest

    Springfield, Missouri, 65807

  • River Region Research, LLC

    Tallassee, Alabama, 36078

  • Office of Laszlo J Mate, M.D.

    West Palm Beach, Florida, 33407

  • The Center for Clinical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A TWO WEEK DOUBLE-BLIND PLACEBO-CONTROLLED CROSSOVER STUDY TO COMPARE THE EFFICACY AND SAFETY OF A PREGABALIN/PF-00489791 COMBINATION VERSUS PREGABALIN ALONE IN PATIENTS WITH POST-HERPETIC NEURALGIA

Pregabalin is an alpha-2 delta ligand approved for the treatment of neuropathic pain, however, not all patients will respond to this drug. This study will compare the efficacy of pregabalin when administered with an experimental drug PF-00489791, in patients with post-herpetic neuralgia. The efficacy of this combination will be compared to pregabalin alone.

Being tested
pregabalin, pregabalin/PF-00489791, Placebo
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

    75mg bid titrating to 150mg bid on day 4

  • pregabalin/PF-00489791Drug

    Pregabalin 75mg bid titrating to 150mg bid on day 4; PF-00489791: 4mg od titrating to 10mg od on day 4

  • PlaceboDrug

    Placebo

Study groups in NCT00599638
Study groupRoleWhat they receive
1Active comparatorNot described
Receives: Drug: pregabalin
2ExperimentalNot described
Receives: Drug: pregabalin/PF-00489791
3Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Mean Pain Score on Daily Pain Rating Scale (DPRS)

    Pain was assessed by using a daily pain rating scale that consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"), higher scores indicate more pain intensity. Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily. The mean pain score was defined as the mean of the last 7 daily pain ratings scale scores while taking study medication, at end of each treatment period: Period 1 (Week 2) and Period 2 (Week 6), respectively. Mean pain score had a score range of 0 (no pain) to 10 (worst possible pain), higher scores indicate more pain. Cumulative data of mean pain scores at end of treatment for both the periods was calculated and reported in terms of adjusted mean and standard error.

    Measured: End of treatment period (included both Week 2 and Week 6)

Secondary outcomes (8)

  1. Percentage of Participants With Patient Global Impression of Change (PGIC) Score

    The PGIC is a participant-rated instrument that measures change in the participants' overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse), lower scores indicated more improvement. PGIC was evaluated using 3 categories: improvement (scores 1-3), no change (score 4), and worsening (scores 5-7). In this outcome measure percentage of participants with categories: improved, no change and worsening, based on PGIC score were reported. Cumulative data at end of treatment for both the periods (Period 1 [Week 2] and Period 2 [Week6]) was calculated and reported.

    Measured: End of treatment period (included both Week 2 and Week 6)

  2. Pain Visual Analogue Scale (VAS) at Baseline and Week 4

    Participants marked intensity of the pain on a scale, ranging from 0 millimeters (mm) = no pain to 100 mm = worst possible pain, where higher scores indicate more pain.

    Measured: Baseline, Week 4

  3. Neuropathic Pain Symptom Inventory (NPSI)

    Participant rated 10-item questionnaire to evaluate different symptoms of neuropathic pain (spontaneous pain like [item 1 to 3]: burning, squeezing, pressure; painful attack like [item 4 to 5]: electric shock, stabbing; pain provoked on [item 6 to 8]: light touching, pressure, contact with something cold; abnormal sensations like [item 9 to 10]: pins and needles, tingling). Each item was rated on an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity of pain). Total NPSI scale ranged from 0 (no pain) to 100 (maximum pain). Higher scores indicate a greater intensity of pain. Cumulative data of NPSI scale at end of treatment for both the periods (Period 1 [Week 2] and Period 2 [Week 6]) was calculated and reported in terms of adjusted mean and standard error.

    Measured: End of treatment period (included both Week 2 and Week 6)

  4. Number of Participants With Clinically Significant Vital Signs Abnormalities

    Vital signs abnormalities included sitting, standing: systolic, diastolic blood pressure and heart rate. Clinical significance was judged by investigator.

    Measured: Baseline up to Week 7

  5. Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

    Criteria for ECG abnormalities: Maximum QTc (corrected QT) interval, QTcB (Bazett's correction formula) and QTcF (Fridericia's correction formula): 450 to less than (<) 480 milliseconds (msec), 480 to <500 msec and greater than equal to (>=) 500 msec; Maximum QTc interval increase from baseline: >=30 to <60 and >=60 (msec); PR interval: >=300 msec and percent change >=25 or 50 percent; QRS complex: percent change >=25 or 50 percent. Clinical significance was judged by investigator.

    Measured: Baseline up to Week 7

  6. Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology

    Criteria for hematology abnormalities included Hemoglobin: <0.8*lower limit of normal (LLN) and hematocrit: <0.8*LLN. Clinical significance was judged by investigator.

    Measured: Baseline up to Week 7

  7. Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry

    Criteria for clinical chemistry abnormalities included total bilirubin: greater than (>) 1.5*upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase: >3.0*ULN; total protein, albumin: <0.8*LLN or >1.2*ULN; blood urea nitrogen, creatinine: >1.3*ULN; uric acid: >1.2*ULN; sodium: <0.95*LLN or >1.05*ULN; potassium, chloride, calcium: <0.9*LLN or >1.1*ULN; creatine kinase: >2.0*ULN. Clinical significance was judged by investigator.

    Measured: Baseline up to Week 7

  8. Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis

    Urinalysis abnormalities criteria included: urine specific gravity: <1.003 to >1.030; urine pH: <4.5 to >8; urine glucose, urine ketones, urine proteins, urine blood/hemoglobin: >=1. Clinical significance was judged by investigator.

    Measured: Baseline up to Week 7

Timeline

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

  1. First posted24 Jan 2008 (estimated)
  2. Study start9 Apr 2008
  3. Primary completion16 Dec 2008
  4. Study completion23 Dec 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00599638
Sponsor's protocol ID
B0261002
Status last verified
Aug 2021
First submitted
4 Jan 2008
Last updated
5 Aug 2021
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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pregabalin and pregabalin/PF-00489791 in people with Postherpetic Neuralgia, run by Pfizer at 39 sites in United States.

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 5 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 39 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 5 Aug 2021). 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 Score on Daily Pain Rating Scale (DPRS) (time frame: End of treatment period (included both Week 2 and Week 6)). 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 NCT00599638.

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 5 Aug 2021.

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

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in