- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00159640
Placebo Controlled Dose-Response Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia
March 27, 2007 updated by: Pfizer
A Multi-Center, Randomized, Double Blind, Dose-Response, Placebo And Gabapentin Controlled Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia
The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of chronic pain following a shingles infection.
Study Overview
Study Type
Interventional
Enrollment
315
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
- Pfizer Investigational Site
-
-
-
-
-
Woodville, Australia
- Pfizer Investigational Site
-
-
New South Wales
-
Warrawong, New South Wales, Australia
- Pfizer Investigational Site
-
Westmead, New South Wales, Australia
- Pfizer Investigational Site
-
-
Queensland
-
Kippa Ring, Queensland, Australia
- Pfizer Investigational Site
-
Maroochydore, Queensland, Australia
- Pfizer Investigational Site
-
-
South Australia
-
Bedford Park, South Australia, Australia
- Pfizer Investigational Site
-
-
Western Australia
-
Perth, Western Australia, Australia
- Pfizer Investigational Site
-
-
-
-
British Columbia
-
Kelowna, British Columbia, Canada
- Pfizer Investigational Site
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada
- Pfizer Investigational Site
-
-
Ontario
-
Toronto, Ontario, Canada
- Pfizer Investigational Site
-
-
Quebec
-
Sherbrooke, Quebec, Canada
- Pfizer Investigational Site
-
Ste-foy, Quebec, Canada
- Pfizer Investigational Site
-
-
-
-
-
Brno, Czech Republic
- Pfizer Investigational Site
-
CZ-Praha 8, Czech Republic
- Pfizer Investigational Site
-
Ceske Budejovice, Czech Republic
- Pfizer Investigational Site
-
Plzen, Czech Republic
- Pfizer Investigational Site
-
Praha 5, Czech Republic
- Pfizer Investigational Site
-
-
-
-
-
Arnhem, Netherlands
- Pfizer Investigational Site
-
Breda, Netherlands
- Pfizer Investigational Site
-
Kampen, Netherlands
- Pfizer Investigational Site
-
Roosendaal, Netherlands
- Pfizer Investigational Site
-
Rotterdam, Netherlands
- Pfizer Investigational Site
-
Stadskanaal, Netherlands
- Pfizer Investigational Site
-
-
-
-
-
Barcelona, Spain
- Pfizer Investigational Site
-
Granada, Spain
- Pfizer Investigational Site
-
Madrid, Spain
- Pfizer Investigational Site
-
Malaga, Spain
- Pfizer Investigational Site
-
Sevilla, Spain
- Pfizer Investigational Site
-
-
-
-
-
London, United Kingdom
- Pfizer Investigational Site
-
-
Hants
-
Portsmouth, Hants, United Kingdom
- Pfizer Investigational Site
-
-
Northants
-
Northampton, Northants, United Kingdom
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must have pain present for more than 3 months after the healing of shingles skin rash.
- Patients at screening must have a score >=40 mm on the pain visual analogue scale.
Exclusion Criteria:
- Patients with poor renal function.
- Patients with other severe pain, that may impair the self-assessment of the pain due to shingles.
- Patients with abnormal electrocardiogram.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
To characterise the effectiveness of PD-217,014 in the treatment of chronic pain. A numerical pain intensity rating scale is used to assess pain and a mean endpoint (week 4) pain score change from baseline is calculated.
|
Secondary Outcome Measures
Outcome Measure |
---|
- Assess the effect of PD-217,014 on responder rate based on the primary endpoint, mean endpoint sleep interference score and the SF-McGill questionnaire (change from baseline to week 4)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Study Registration Dates
First Submitted
September 7, 2005
First Submitted That Met QC Criteria
September 7, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
March 28, 2007
Last Update Submitted That Met QC Criteria
March 27, 2007
Last Verified
March 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A4451006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
Clinical Trials on PD-217,014
-
PfizerCompletedIrritable Bowel Syndrome
-
Yale UniversityNational Institute of Neurological Disorders and Stroke (NINDS)CompletedParkinson DiseaseUnited States
-
Lars Møller PedersenCompletedFollicular LymphomaDenmark
-
Peking University First HospitalTerminated
-
PfizerCompletedInterstitial Cystitis | Painful Bladder SyndromeCanada, United States, France, Denmark, Finland, Germany
-
Shanghai Zhongshan HospitalRecruiting
-
The University of QueenslandThe HOME Network; Australia and New Zealand Dialysis and Transplant Registry; New Zealand Peritoneal Dialysis RegistryRecruitingKidney Disease, Chronic | Peritoneal Dialysis Catheter Exit Site Infection | Peritoneal Dialysis Catheter-Associated Peritonitis | Peritoneal Dialysis Catheter Tunnel InfectionAustralia, New Zealand
-
Centre Leon BerardNETRIS PharmaRecruitingAdvanced Solid Tumors | Metastatic Solid TumorsFrance
-
University of CalgaryMcGill University; University of Ottawa; Queen's University; Halton Health (Oakville) and other collaboratorsRecruiting
-
Thomas MarronRecruiting