A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia
perjantai 28. toukokuuta 2010 päivittänyt: Eli Lilly and Company
Flexible Dosed Duloxetine Versus Placebo in the Treatment of Fibromyalgia
The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once daily in comparison to placebo on symptom improvement in patients meeting criteria for fibromyalgia aged 18 and older.
Patients will be randomized to duloxetine or placebo, however, all patients will receive duloxetine at some point in the study.
Tutkimuksen yleiskatsaus
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
530
Vaihe
- Vaihe 4
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Hato Rey, Puerto Rico, 00918
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ponce, Puerto Rico, 00716
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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San Juan, Puerto Rico, 00935
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Arizona
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Phoenix, Arizona, Yhdysvallat, 85050
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tucson, Arizona, Yhdysvallat, 85741
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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California
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Los Angeles, California, Yhdysvallat, 90024
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pasadena, California, Yhdysvallat, 91105
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Connecticut
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Cromwell, Connecticut, Yhdysvallat, 06416
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Danbury, Connecticut, Yhdysvallat, 06810
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Florida
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Bradenton, Florida, Yhdysvallat, 34208
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Deland, Florida, Yhdysvallat, 32720
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Fort Myers, Florida, Yhdysvallat, 33912
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Orlando, Florida, Yhdysvallat, 32806
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South Miami, Florida, Yhdysvallat, 33143
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tampa, Florida, Yhdysvallat, 33606
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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West Palm Beach, Florida, Yhdysvallat, 33407
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Illinois
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Oak Brook, Illinois, Yhdysvallat, 60523
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Indiana
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Lafayette, Indiana, Yhdysvallat, 47905
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kansas
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Prairie Village, Kansas, Yhdysvallat, 66206
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Maryland
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Rockville, Maryland, Yhdysvallat, 20852
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Massachusetts
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Belmont, Massachusetts, Yhdysvallat, 02478
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Fall River, Massachusetts, Yhdysvallat, 02721
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Newton, Massachusetts, Yhdysvallat, 02462
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Springfield, Massachusetts, Yhdysvallat, 01103
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Michigan
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Ann Arbor, Michigan, Yhdysvallat, 48104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Missouri
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St Louis, Missouri, Yhdysvallat, 63141
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Jersey
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Edison, New Jersey, Yhdysvallat, 08817
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Piscataway, New Jersey, Yhdysvallat, 08854
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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North Carolina
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Greensboro, North Carolina, Yhdysvallat, 27408
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ohio
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Cincinnati, Ohio, Yhdysvallat, 45219
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Toledo, Ohio, Yhdysvallat, 43623
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oklahoma
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Oklahoma City, Oklahoma, Yhdysvallat, 73109
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oregon
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Eugene, Oregon, Yhdysvallat, 97404
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Portland, Oregon, Yhdysvallat, 97210
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pennsylvania
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Philadelphia, Pennsylvania, Yhdysvallat, 19107
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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South Carolina
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Myrtle Beach, South Carolina, Yhdysvallat, 29572
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Texas
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Dallas, Texas, Yhdysvallat, 75231
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lake Jackson, Texas, Yhdysvallat, 77566
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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San Antonio, Texas, Yhdysvallat, 78229
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Waco, Texas, Yhdysvallat, 76708
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wichita Falls, Texas, Yhdysvallat, 76309
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Utah
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West Jordan, Utah, Yhdysvallat, 84088
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Washington
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Bellevue, Washington, Yhdysvallat, 98007
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Seattle, Washington, Yhdysvallat, 98104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tacoma, Washington, Yhdysvallat, 98405
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wisconsin
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Middleton, Wisconsin, Yhdysvallat, 53562
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
Inclusion Criteria:
- male or female patients
- aged 18 and older who meet criteria for fibromyalgia as defined by the American College of Rheumatology
- have a score of at least 4 on the average pain item of the Brief Pain Inventory (BPI) (modified short form) at visits 1 and 2
- all females must test negative for pregnancy at the time of enrollment
- have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator.
Exclusion Criteria:
- have pain symptoms related to traumatic injury, structural rheumatic disease, or regional rheumatic disease that will interfere with interpretation of outcome measures
- have regional pain syndrome, multiple surgeries or failed back syndrome
- have confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (i.e. systemic lupus erythematosus)
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Duloxetine
60-120 mg, oral, every day, 12 weeks
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60-120 mg, oral, every day, 12 weeks (acute blinded phase followed by a 12 week blinded continuation phase).
Muut nimet:
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Placebo Comparator: Placebo
oral, daily, 12 weeks
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oral, daily, 12 weeks (acute blinded phase followed by 12 weeks of blinded duloxetine treatment)
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Patient's Global Impressions of Improvement (PGI-I) at Week 12
Aikaikkuna: 12 weeks
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The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms.
It is a 7-point scale where a score of 1 indicates that the patient is "very much improved," a score of 4 indicates that the patient has experienced "no change," and a score of 7 indicates that the patient is "very much worse."
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12 weeks
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Change From Baseline in Brief Pain Inventory (BPI) (Modified Short Form) at 12 Week Endpoint
Aikaikkuna: Baseline, 12 weeks
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BPI is a self-reported form that assesses severity of pain and the interference of pain on function.
There are 4 questions assessing the severity for worst pain, least pain, and average pain in the past 24 hours, and the pain right now.
Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).
There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Interference scores range from 0 (does not interfere) to 10 (completely interferes).
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Baseline, 12 weeks
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Change From Baseline in Multidimensional Fatigue Inventory (MFI) at 12 Week Endpoint
Aikaikkuna: Baseline, 12 weeks
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MFI is a 20-item, self-reporting instrument designed to collect data on the following 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity.
Each dimension score is derived by summing the scores of the 4 individual items that pertain to each dimension.
Item scores range from 1 to 5; thus, dimensional scores range from 4 to 20 with a higher score reflecting greater levels of fatigue.
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Baseline, 12 weeks
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Change From Baseline in Beck Depression Inventory-II (BDI-II) at 12 Week Endpoint
Aikaikkuna: Baseline, 12 weeks
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BDI-II is a 21-item patient-completed questionnaire designed to assess characteristics of depression.
Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme).
This questionnaire will be used to rate the severity of depressive symptoms and any improvement during the course of the trial.
The total score ranges from 0 to 63; the higher the score, the more severe the depressive symptoms.
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Baseline, 12 weeks
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Change From Baseline in Clinical Global Impressions of Severity (CGI-S) at 12 Week Endpoint
Aikaikkuna: Baseline, 12 Weeks
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The Clinical Global Impressions of Severity (CGI-Severity) scale evaluates the severity of illness at the time of assessment.
The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
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Baseline, 12 Weeks
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Change From Baseline in Beck Anxiety Inventory (BAI) at 12 Week Endpoint
Aikaikkuna: Baseline, 12 weeks
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BAI is a 21-item patient-completed questionnaire designed to assess characteristics of anxiety.
Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme).
This questionnaire will be used to rate the severity of anxiety symptoms and any improvement during the course of the trial.
The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms.
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Baseline, 12 weeks
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Change From Baseline in 36-Item Short-form Health Survey (SF-36) at 12 Weeks
Aikaikkuna: Baseline, 12 weeks
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The patient-rated SF-36 consists of 36 questions covering eight health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality.
Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.
Two summary scores: the Physical Component Summary and the Mental Component Summary are constructed based on the eight SF-36 domains.
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Baseline, 12 weeks
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Change From Baseline in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score at 12 Week Endpoint
Aikaikkuna: Baseline, 12 weeks
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The MGH-CPFQ is a self-report instrument consisting of seven questions pertaining to an individual's cognitive and physical well-being.
Each question is rated 1 = "greater than normal" to 6 = "totally absent".
Total score ranges from 7 to 42.
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Baseline, 12 weeks
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Change From Baseline in the Mood, Anxiety, Pain, Sleep, and Stiffness Likert Scale at 12 Week Endpoint
Aikaikkuna: Baseline, 12 weeks
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Likert scales are patient-rated assessments.
Mood: feeling low, sad or depressed; rated 0 = not feeling low, sad or depressed to 10 = feeling extremely low, sad or depressed.
Anxious: anxious feelings; rated 0 = not feeling anxious to 10 = extremely anxious.
Sleep: how much patient bothered by sleep difficulties; rated 0 = not bothered to 10 = extremely bothered.
Pain: how much patient bothered by painful physical discomforts; rated 0 = not bothered to 10 = extremely bothered.
Stiffness: how stiff patient felt in past 24 hours; rated 0 = not felt any stiffness to 10 = felt extremely stiff.
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Baseline, 12 weeks
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Number of Responders: 30% Improvement in Brief Pain Inventory Average Pain at 12 Week Endpoint
Aikaikkuna: 12 Weeks
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Response was defined as at least 30% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score.
BPI average pain score assesses the severity of the average pain in the past 24 hours.
The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
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12 Weeks
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Number of Responders: 50% Improvement in Brief Pain Inventory Average Pain Score at 12 Week Endpoint
Aikaikkuna: 12 weeks
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Response was defined as at least 50% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score.
BPI average pain score assesses the severity of the average pain in the past 24 hours.
The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
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12 weeks
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Change From Baseline in Blood Pressure at 12 Week Endpoint
Aikaikkuna: Baseline, 12 weeks
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Baseline, 12 weeks
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Change From Baseline in Heart Rate at 12 Week Endpoint
Aikaikkuna: Baseline, 12 weeks
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Baseline, 12 weeks
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Number of Patients With Columbia Suicide Severity Rating Scale (CSSR-S) Events (Behaviors, Ideations, Acts)
Aikaikkuna: Baseline through 12 Weeks
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C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors.
Number of patients with suicidal behaviors, ideations, and acts are provided.
Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.
Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation.
Suicidal act: a "yes" answer to actual attempt or completed suicide.
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Baseline through 12 Weeks
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Change From Baseline in Weight at 12 Week Endpoint
Aikaikkuna: Baseline, 12 weeks
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Baseline, 12 weeks
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Yhteistyökumppanit
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- Mohs R, Mease P, Arnold LM, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. The effect of duloxetine treatment on cognition in patients with fibromyalgia. Psychosom Med. 2012 Jul-Aug;74(6):628-34. doi: 10.1097/PSY.0b013e31825b9855. Epub 2012 Jun 28.
- Arnold LM, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. Improvement in multiple dimensions of fatigue in patients with fibromyalgia treated with duloxetine: secondary analysis of a randomized, placebo-controlled trial. Arthritis Res Ther. 2011 Jun 13;13(3):R86. doi: 10.1186/ar3359.
- Arnold LM, Clauw D, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. Flexible dosed duloxetine in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled trial. J Rheumatol. 2010 Dec;37(12):2578-86. doi: 10.3899/jrheum.100365. Epub 2010 Sep 15.
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Sunnuntai 1. kesäkuuta 2008
Ensisijainen valmistuminen (Todellinen)
Keskiviikko 1. huhtikuuta 2009
Opintojen valmistuminen (Todellinen)
Keskiviikko 1. heinäkuuta 2009
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 5. toukokuuta 2008
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Tiistai 6. toukokuuta 2008
Ensimmäinen Lähetetty (Arvio)
Keskiviikko 7. toukokuuta 2008
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Torstai 24. kesäkuuta 2010
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Perjantai 28. toukokuuta 2010
Viimeksi vahvistettu
Lauantai 1. toukokuuta 2010
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
- 12220 (Muu tunniste: Company Internal)
- F1J-US-HMGB (Muu tunniste: Eli Lilly and Company)
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