- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00288652
[S,S]-Reboxetine Dose-Range Finding Trial
7. juni 2011 opdateret af: Pfizer
[S,S]-Reboxetine Dose-Range Finding Trial: A 16-Week, Randomized, Double-Blind, Placebo And An Active Comparator Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN)
The purpose of this study is to determine the effectiveness of different doses of [S,S]-Reboxetine in the treatment of chronic pain following a shingles infection
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding
280
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Huntsville, Alabama, Forenede Stater
- Pfizer Investigational Site
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Arizona
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Chandler, Arizona, Forenede Stater
- Pfizer Investigational Site
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Mesa, Arizona, Forenede Stater
- Pfizer Investigational Site
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Phoenix, Arizona, Forenede Stater
- Pfizer Investigational Site
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Sun City, Arizona, Forenede Stater
- Pfizer Investigational Site
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Tucson, Arizona, Forenede Stater
- Pfizer Investigational Site
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Arkansas
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Hot Springs, Arkansas, Forenede Stater
- Pfizer Investigational Site
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California
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Arcadia, California, Forenede Stater
- Pfizer Investigational Site
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Fullerton, California, Forenede Stater
- Pfizer Investigational Site
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Irvine, California, Forenede Stater
- Pfizer Investigational Site
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Laguna Hills, California, Forenede Stater
- Pfizer Investigational Site
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Loma Linda, California, Forenede Stater
- Pfizer Investigational Site
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Orange, California, Forenede Stater
- Pfizer Investigational Site
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Redondo Beach, California, Forenede Stater
- Pfizer Investigational Site
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Whittier, California, Forenede Stater
- Pfizer Investigational Site
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Colorado
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Boulder, Colorado, Forenede Stater
- Pfizer Investigational Site
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Florida
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Bradenton, Florida, Forenede Stater
- Pfizer Investigational Site
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Clearwater, Florida, Forenede Stater
- Pfizer Investigational Site
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Ft. Myers, Florida, Forenede Stater
- Pfizer Investigational Site
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Holly Hill, Florida, Forenede Stater
- Pfizer Investigational Site
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Hollywood, Florida, Forenede Stater
- Pfizer Investigational Site
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Kissimmee, Florida, Forenede Stater
- Pfizer Investigational Site
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Largo, Florida, Forenede Stater
- Pfizer Investigational Site
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Longwood, Florida, Forenede Stater
- Pfizer Investigational Site
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Melbourne, Florida, Forenede Stater
- Pfizer Investigational Site
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Ocala, Florida, Forenede Stater
- Pfizer Investigational Site
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Oviedo, Florida, Forenede Stater
- Pfizer Investigational Site
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Palm Beach Gardens, Florida, Forenede Stater
- Pfizer Investigational Site
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Plantation, Florida, Forenede Stater
- Pfizer Investigational Site
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Illinois
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Chicago, Illinois, Forenede Stater
- Pfizer Investigational Site
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Oak Brook, Illinois, Forenede Stater
- Pfizer Investigational Site
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Indiana
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Evansville, Indiana, Forenede Stater
- Pfizer Investigational Site
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Kansas
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Topeka, Kansas, Forenede Stater
- Pfizer Investigational Site
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Louisiana
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Ruston, Louisiana, Forenede Stater
- Pfizer Investigational Site
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Maryland
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Towson, Maryland, Forenede Stater
- Pfizer Investigational Site
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Massachusetts
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Boston, Massachusetts, Forenede Stater
- Pfizer Investigational Site
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Brockton, Massachusetts, Forenede Stater
- Pfizer Investigational Site
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Michigan
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Ann Arbor, Michigan, Forenede Stater
- Pfizer Investigational Site
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Mississippi
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Southaven, Mississippi, Forenede Stater
- Pfizer Investigational Site
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Missouri
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Independence, Missouri, Forenede Stater
- Pfizer Investigational Site
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Kansas City, Missouri, Forenede Stater
- Pfizer Investigational Site
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Nixa, Missouri, Forenede Stater
- Pfizer Investigational Site
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Sprinfield, Missouri, Forenede Stater
- Pfizer Investigational Site
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St. Louis, Missouri, Forenede Stater
- Pfizer Investigational Site
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Montana
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Billings, Montana, Forenede Stater
- Pfizer Investigational Site
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New Jersey
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Clifton, New Jersey, Forenede Stater
- Pfizer Investigational Site
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Hackensack, New Jersey, Forenede Stater
- Pfizer Investigational Site
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Teaneck, New Jersey, Forenede Stater
- Pfizer Investigational Site
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New Mexico
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Sante Fe, New Mexico, Forenede Stater
- Pfizer Investigational Site
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New York
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Albany, New York, Forenede Stater
- Pfizer Investigational Site
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Amherst, New York, Forenede Stater
- Pfizer Investigational Site
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New York, New York, Forenede Stater
- Pfizer Investigational Site
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Orchard Park, New York, Forenede Stater
- Pfizer Investigational Site
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Rochester, New York, Forenede Stater
- Pfizer Investigational Site
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North Carolina
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Asheville, North Carolina, Forenede Stater
- Pfizer Investigational Site
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Raleigh, North Carolina, Forenede Stater
- Pfizer Investigational Site
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Winston-Salem, North Carolina, Forenede Stater
- Pfizer Investigational Site
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North Dakota
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Fargo, North Dakota, Forenede Stater
- Pfizer Investigational Site
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Ohio
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Canfield, Ohio, Forenede Stater
- Pfizer Investigational Site
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Cincinnati, Ohio, Forenede Stater
- Pfizer Investigational Site
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Cleveland, Ohio, Forenede Stater
- Pfizer Investigational Site
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Columbus, Ohio, Forenede Stater
- Pfizer Investigational Site
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Kettering, Ohio, Forenede Stater
- Pfizer Investigational Site
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Toledo, Ohio, Forenede Stater
- Pfizer Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater
- Pfizer Investigational Site
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Pennsylvania
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Allentown, Pennsylvania, Forenede Stater
- Pfizer Investigational Site
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Altoona, Pennsylvania, Forenede Stater
- Pfizer Investigational Site
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Duncansville, Pennsylvania, Forenede Stater
- Pfizer Investigational Site
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Tennessee
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Jackson, Tennessee, Forenede Stater
- Pfizer Investigational Site
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Kingsport, Tennessee, Forenede Stater
- Pfizer Investigational Site
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Texas
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Austin, Texas, Forenede Stater
- Pfizer Investigational Site
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Dallas, Texas, Forenede Stater
- Pfizer Investigational Site
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Houston, Texas, Forenede Stater
- Pfizer Investigational Site
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San Antonio, Texas, Forenede Stater
- Pfizer Investigational Site
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Virginia
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Norfolk, Virginia, Forenede Stater
- Pfizer Investigational Site
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Richmond, Virginia, Forenede Stater
- Pfizer Investigational Site
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Washington
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Seattle, Washington, Forenede Stater
- Pfizer Investigational Site
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Spokane, Washington, Forenede Stater
- Pfizer Investigational Site
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Tacoma, Washington, Forenede Stater
- Pfizer Investigational Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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 significant renal and hepatic impairment
- Patients with other severe pain, that may impair the self-assessment of the pain due to shingles
- Patients with clinically abnormal electrocardiogram
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 14 will be calculated
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Sekundære resultatmål
Resultatmål |
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- The mean endpoint (week 14) sleep interference score change from baseline - Analysis of the Medical Outcomes Study Sleep Scale - Analysis of the Patient Global Impression of Change - Analysis of the SF-36 Health Survey
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2006
Studieafslutning (Faktiske)
1. februar 2007
Datoer for studieregistrering
Først indsendt
7. februar 2006
Først indsendt, der opfyldte QC-kriterier
7. februar 2006
Først opslået (Skøn)
8. februar 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. juni 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. juni 2011
Sidst verificeret
1. juni 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- A6061026
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Smerte
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Istanbul University - CerrahpasaRekrutteringPatellofemoral Pain, PfpTyrkiet (Türkiye)
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Pamukkale UniversityIkke rekrutterer endnuPatellofemoral Pain, PfpTyrkiet (Türkiye)
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Beijing Sport UniversityAfsluttetPatellofemoral Pain, PfpKina
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Beijing Sport UniversityIkke rekrutterer endnuPatellofemoral Pain, Pfp
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Beijing Sport UniversityIkke rekrutterer endnu
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Sahmyook UniversityAfsluttetMyofascial Pain Syndrome (MPS)Sydkorea
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Future University in EgyptAfsluttet
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Camilo Jose Cela UniversityAfsluttetMyofascial Pain Syndrome (MPS)Spanien
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Izmir Tinaztepe UniversityEge UniversityIkke rekrutterer endnuRygliggende stilling | FLACC Skala | Behavioral Pain Scale
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University of California, DavisNational Institutes of Health (NIH); National Center for Complementary...Ikke rekrutterer endnuKronisk lænderygsmerter (cLBP) | Myofascial Pain Syndrome (MPS)Forenede Stater
Kliniske forsøg med [S,S]-Reboxetin
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Pfizer's Upjohn has merged with Mylan to form Viatris...AfsluttetDepressiv lidelse, majorDen Russiske Føderation, Estland
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PfizerAfsluttetFibromyalgiCanada, Forenede Stater, Belgien, Tyskland, Sverige, Korea, Republikken, Holland, Det Forenede Kongerige, Frankrig, Tjekkiet, Sydafrika
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PfizerAfsluttet
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PfizerAfsluttet
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PfizerAfsluttet
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PfizerAfsluttetFibromyalgiCanada, Forenede Stater
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PfizerAfsluttetDiabetiske neuropatierHolland, Forenede Stater, Spanien, Finland, Sydafrika, Tjekkiet
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PfizerAfsluttetFibromyalgiCanada, Forenede Stater
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PfizerAfsluttetSmerteCanada, Forenede Stater, Indien, Chile, Mexico, Spanien, Det Forenede Kongerige, Kroatien, Argentina, Litauen, Polen, Sverige
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Boston Scientific CorporationAfsluttetTakykardi, VentrikulærDet Forenede Kongerige, Danmark, Italien, New Zealand, Tyskland, Frankrig, Holland, Portugal, Tjekkiet, Spanien