A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia
28 maja 2010 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
530
Faza
- Faza 4
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
-
Hato Rey, Portoryko, 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.
-
Ponce, Portoryko, 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.
-
San Juan, Portoryko, 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.
-
-
-
-
Arizona
-
Phoenix, Arizona, Stany Zjednoczone, 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.
-
Tucson, Arizona, Stany Zjednoczone, 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.
-
-
California
-
Los Angeles, California, Stany Zjednoczone, 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.
-
Pasadena, California, Stany Zjednoczone, 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.
-
-
Connecticut
-
Cromwell, Connecticut, Stany Zjednoczone, 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.
-
Danbury, Connecticut, Stany Zjednoczone, 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.
-
-
Florida
-
Bradenton, Florida, Stany Zjednoczone, 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.
-
Deland, Florida, Stany Zjednoczone, 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.
-
Fort Myers, Florida, Stany Zjednoczone, 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.
-
Orlando, Florida, Stany Zjednoczone, 32806
- 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.
-
South Miami, Florida, Stany Zjednoczone, 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.
-
Tampa, Florida, Stany Zjednoczone, 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.
-
West Palm Beach, Florida, Stany Zjednoczone, 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.
-
-
Illinois
-
Oak Brook, Illinois, Stany Zjednoczone, 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.
-
-
Indiana
-
Lafayette, Indiana, Stany Zjednoczone, 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.
-
-
Kansas
-
Prairie Village, Kansas, Stany Zjednoczone, 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.
-
-
Maryland
-
Rockville, Maryland, Stany Zjednoczone, 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.
-
-
Massachusetts
-
Belmont, Massachusetts, Stany Zjednoczone, 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.
-
Fall River, Massachusetts, Stany Zjednoczone, 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.
-
Newton, Massachusetts, Stany Zjednoczone, 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.
-
Springfield, Massachusetts, Stany Zjednoczone, 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.
-
-
Michigan
-
Ann Arbor, Michigan, Stany Zjednoczone, 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.
-
-
Missouri
-
St Louis, Missouri, Stany Zjednoczone, 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.
-
-
New Jersey
-
Edison, New Jersey, Stany Zjednoczone, 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.
-
Piscataway, New Jersey, Stany Zjednoczone, 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.
-
-
North Carolina
-
Greensboro, North Carolina, Stany Zjednoczone, 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.
-
-
Ohio
-
Cincinnati, Ohio, Stany Zjednoczone, 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.
-
Toledo, Ohio, Stany Zjednoczone, 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.
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Stany Zjednoczone, 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.
-
-
Oregon
-
Eugene, Oregon, Stany Zjednoczone, 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.
-
Portland, Oregon, Stany Zjednoczone, 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.
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Stany Zjednoczone, 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.
-
-
South Carolina
-
Myrtle Beach, South Carolina, Stany Zjednoczone, 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.
-
-
Texas
-
Dallas, Texas, Stany Zjednoczone, 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.
-
Lake Jackson, Texas, Stany Zjednoczone, 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.
-
San Antonio, Texas, Stany Zjednoczone, 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.
-
Waco, Texas, Stany Zjednoczone, 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.
-
Wichita Falls, Texas, Stany Zjednoczone, 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.
-
-
Utah
-
West Jordan, Utah, Stany Zjednoczone, 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.
-
-
Washington
-
Bellevue, Washington, Stany Zjednoczone, 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.
-
Seattle, Washington, Stany Zjednoczone, 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.
-
Tacoma, Washington, Stany Zjednoczone, 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.
-
-
Wisconsin
-
Middleton, Wisconsin, Stany Zjednoczone, 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.
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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)
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Duloxetine
60-120 mg, oral, every day, 12 weeks
|
60-120 mg, oral, every day, 12 weeks (acute blinded phase followed by a 12 week blinded continuation phase).
Inne nazwy:
|
|
Komparator placebo: Placebo
oral, daily, 12 weeks
|
oral, daily, 12 weeks (acute blinded phase followed by 12 weeks of blinded duloxetine treatment)
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Patient's Global Impressions of Improvement (PGI-I) at Week 12
Ramy czasowe: 12 weeks
|
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."
|
12 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change From Baseline in Brief Pain Inventory (BPI) (Modified Short Form) at 12 Week Endpoint
Ramy czasowe: Baseline, 12 weeks
|
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).
|
Baseline, 12 weeks
|
|
Change From Baseline in Multidimensional Fatigue Inventory (MFI) at 12 Week Endpoint
Ramy czasowe: Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
|
Change From Baseline in Beck Depression Inventory-II (BDI-II) at 12 Week Endpoint
Ramy czasowe: Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
|
Change From Baseline in Clinical Global Impressions of Severity (CGI-S) at 12 Week Endpoint
Ramy czasowe: Baseline, 12 Weeks
|
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).
|
Baseline, 12 Weeks
|
|
Change From Baseline in Beck Anxiety Inventory (BAI) at 12 Week Endpoint
Ramy czasowe: Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
|
Change From Baseline in 36-Item Short-form Health Survey (SF-36) at 12 Weeks
Ramy czasowe: Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
|
Change From Baseline in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score at 12 Week Endpoint
Ramy czasowe: Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
|
Change From Baseline in the Mood, Anxiety, Pain, Sleep, and Stiffness Likert Scale at 12 Week Endpoint
Ramy czasowe: Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
|
Number of Responders: 30% Improvement in Brief Pain Inventory Average Pain at 12 Week Endpoint
Ramy czasowe: 12 Weeks
|
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).
|
12 Weeks
|
|
Number of Responders: 50% Improvement in Brief Pain Inventory Average Pain Score at 12 Week Endpoint
Ramy czasowe: 12 weeks
|
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).
|
12 weeks
|
|
Change From Baseline in Blood Pressure at 12 Week Endpoint
Ramy czasowe: Baseline, 12 weeks
|
Baseline, 12 weeks
|
|
|
Change From Baseline in Heart Rate at 12 Week Endpoint
Ramy czasowe: Baseline, 12 weeks
|
Baseline, 12 weeks
|
|
|
Number of Patients With Columbia Suicide Severity Rating Scale (CSSR-S) Events (Behaviors, Ideations, Acts)
Ramy czasowe: Baseline through 12 Weeks
|
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.
|
Baseline through 12 Weeks
|
|
Change From Baseline in Weight at 12 Week Endpoint
Ramy czasowe: Baseline, 12 weeks
|
Baseline, 12 weeks
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Przydatne linki
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 czerwca 2008
Zakończenie podstawowe (Rzeczywisty)
1 kwietnia 2009
Ukończenie studiów (Rzeczywisty)
1 lipca 2009
Daty rejestracji na studia
Pierwszy przesłany
5 maja 2008
Pierwszy przesłany, który spełnia kryteria kontroli jakości
6 maja 2008
Pierwszy wysłany (Oszacować)
7 maja 2008
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
24 czerwca 2010
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
28 maja 2010
Ostatnia weryfikacja
1 maja 2010
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Choroby Układu Nerwowego
- Choroby układu mięśniowo-szkieletowego
- Choroby reumatyczne
- Choroby mięśni
- Choroby nerwowo-mięśniowe
- Fibromialgia
- Zespoły bólu mięśniowo-powięziowego
- Fizjologiczne skutki leków
- Agentów neuroprzekaźników
- Molekularne mechanizmy działania farmakologicznego
- Agenty obwodowego układu nerwowego
- Środki przeciwbólowe
- Agenci systemu sensorycznego
- Leki psychotropowe
- Inhibitory wychwytu neuroprzekaźników
- Modulatory transportu membranowego
- Środki przeciwdepresyjne
- Agentów dopaminy
- Inhibitory wychwytu zwrotnego serotoniny i noradrenaliny
- Chlorowodorek duloksetyny
Inne numery identyfikacyjne badania
- 12220 (Inny identyfikator: Company Internal)
- F1J-US-HMGB (Inny identyfikator: Eli Lilly and Company)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .