Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome
Dose Response Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Opintotyyppi
Opintotyyppi
Ilmoittautuminen
Ilmoittautuminen
Vaihe
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Opiskelupaikat
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Ponce, Puerto Rico
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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San Juan, Puerto Rico
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Arizona
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Peoria, Arizona, Yhdysvallat
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Phoenix, Arizona, Yhdysvallat
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Tucson, Arizona, Yhdysvallat
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California
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Burbank, California, Yhdysvallat
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Sherman Oaks, California, Yhdysvallat
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Walnut Creek, California, Yhdysvallat
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Connecticut
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Danbury, Connecticut, Yhdysvallat
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Florida
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DeLand, Florida, Yhdysvallat
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Ft. Myers, Florida, Yhdysvallat
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Miami, Florida, Yhdysvallat
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Indiana
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Lafayette, Indiana, Yhdysvallat
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Kansas
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Prairie Village, Kansas, Yhdysvallat
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Massachusetts
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Fall River, Massachusetts, Yhdysvallat
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Springfield, Massachusetts, Yhdysvallat
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Missouri
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St. Louis, Missouri, Yhdysvallat
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New York
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Albany, New York, Yhdysvallat
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North Carolina
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Greensboro, North Carolina, Yhdysvallat
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Ohio
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Cincinnati, Ohio, Yhdysvallat
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Cleveland, Ohio, Yhdysvallat
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Toledo, Ohio, Yhdysvallat
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Oregon
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Eugene, Oregon, Yhdysvallat
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Portland, Oregon, Yhdysvallat
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Pennsylvania
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Philadelphia, Pennsylvania, Yhdysvallat
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Wyomissing, Pennsylvania, Yhdysvallat
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Rhode Island
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Cranston, Rhode Island, Yhdysvallat
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South Carolina
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Mt. Pleasant, South Carolina, Yhdysvallat
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Myrtle Beach, South Carolina, Yhdysvallat
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Texas
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Austin, Texas, Yhdysvallat
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Lake Jackson, Texas, Yhdysvallat
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San Antonio, Texas, Yhdysvallat
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Vermont
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Woodstock, Vermont, Yhdysvallat
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Washington
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Kirkland, Washington, Yhdysvallat
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Seattle, Washington, Yhdysvallat
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Meet criteria for primary Fibromyalgia Syndrome as defined by the American College of Rheumatology
Exclusion Criteria:
- Have any current primary Axis I diagnosis other than major depressive disorder
- Have any current or previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder
- Have any primary diagnosis of anxiety disorder within the past year (including panic disorder, agoraphobia, OCD, PTSD, GAD and social phobia)
- Have regional pain syndrome, multiple surgeries or failed back syndrome
- Have a confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infective arthritis, or an autoimmune disease (e.g. lupus)
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
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Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome
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Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
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Elämänlaatu
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Sheehan Disability Scale total score
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Average pain item of the BPI and the endpoint of the PGI-Improvement
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Reduction of pain severity
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Evaluate efficacy through the following: Fibromyalgia Impact Questionnaire, CGI-Severity, Tender-point pain thresholds, Multidimensional Fatigue Inventory, BPI average pain score, BPI severity and Interference scores
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Effect duloxetine on pain is independent of MDD or mood improvement
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Assess safety of duloxetine
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Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Yhteistyökumppanit
Yhteistyökumppanit
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Mease PJ, Spaeth M, Clauw DJ, Arnold LM, Bradley LA, Russell IJ, Kajdasz DK, Walker DJ, Chappell AS. Estimation of minimum clinically important difference for pain in fibromyalgia. Arthritis Care Res (Hoboken). 2011 Jun;63(6):821-6. doi: 10.1002/acr.20449.
- Russell JI, Mease PJ, Smith TR, Kajdasz DK, Wohlreich MM, Detke MJ, Walker DJ, Chappell AS, Arnold LM. Efficacy and safety of duloxetine for treatment of fibromyalgia in patients with or without major depressive disorder: Results from a 6-month, randomized, double-blind, placebo-controlled, fixed-dose trial. Pain. 2008 Jun;136(3):432-444. doi: 10.1016/j.pain.2008.02.024. Epub 2008 Apr 18.
Opintojen ennätyspäivät
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Opiskelun aloitus
Opintojen valmistuminen (Todellinen)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Hermoston sairaudet
- Tuki- ja liikuntaelinten sairaudet
- Reumaattiset sairaudet
- Lihassairaudet
- Neuromuskulaariset sairaudet
- Fibromyalgia
- Myofaskiaalinen kipuoireyhtymä
- Huumeiden fysiologiset vaikutukset
- Neurotransmitterit
- Farmakologisen vaikutuksen molekyylimekanismit
- Ääreishermoston aineet
- Analgeetit
- Aistijärjestelmän agentit
- Psykotrooppiset lääkkeet
- Neurotransmitterien sisäänoton estäjät
- Kalvon kuljetusmodulaattorit
- Masennuslääkkeet
- Dopamiini-aineet
- Serotoniinin ja noradrenaliinin takaisinoton estäjät
- Duloksetiinihydrokloridi
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- 6222
- F1J-MC-HMCJ
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