A Study of Duloxetine in Fibromyalgia

This study has been completed.
Sponsor:
Collaborator:
Shionogi
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01552057
First received: March 9, 2012
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

The purpose of the study is to assess the effectiveness and safety of duloxetine in participants with fibromyalgia.


Condition Intervention Phase
Fibromyalgia
Drug: Duloxetine 60 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Clinical Trial of Duloxetine in Participants With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change From Baseline to 14-Week Endpoint in the Brief Pain Inventory (BPI) 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score [ Time Frame: Baseline, 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Global Impression - Improvement at Endpoint [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Improvement at Endpoint [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 14-Week Endpoint in Fibromyalgia Impact Questionnaire [ Time Frame: Baseline, 14 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 14-Week Endpoint in 36-Item Short-Form Health Survey [ Time Frame: Baseline, 14 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 14-Week Endpoint in Beck Depression Inventory-II [ Time Frame: Baseline, 14 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 14-Week Endpoint in Widespread Pain Index and Symptom Severity in American College of Rheumatology Fibromyalgia Diagnostic Criteria 2010 [ Time Frame: Baseline, 14 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 14-Week Endpoint in Average Pain and Worst Pain Severity Score within 24-hours in Patient Diary [ Time Frame: Baseline, 14 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 14-Week Endpoint in BPI Pain Severity Items and Interference Items of the BPI-Modified Short Form Score [ Time Frame: Baseline, 14 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 354
Study Start Date: March 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Duloxetine 60 mg
Duloxetine hydrochloride 60 milligrams (mg) orally for 15 weeks
Drug: Duloxetine 60 mg
Duloxetine 60 milligram (mg) taken orally once every day for 15 weeks
Other Names:
  • LY248686
  • Cymbalta
Placebo Comparator: Placebo
Placebo orally for 15 weeks
Drug: Placebo
Placebo taken orally once every day for 15 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants fulfilling the following criteria in the American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia
  • Participants with pain rated severity 4 or over by BPI - average pain severity item (question 3)

Exclusion Criteria:

  • Participants with serious cardiovascular, hepatic, renal, respiratory, or hematological disease, or clinically significant laboratory or electrocardiogram abnormality which indicate a serious medical problem or require significant intervention in the judgment of the investigators
  • Participants with alanine aminotransferase/aspartate aminotransferase of not less than 100 IU/L or total bilirubin of not less than 1.6 mg/dL
  • Participants with serum creatinine level of not less than 2.0 mg/dL, participant who has undergone kidney transplantation or hemodialysis
  • Participants with pain difficult to discriminate from pain associated with fibromyalgia or disease which disturbs the assessment
  • Participants with treatment-refractory fibromyalgia
  • Participants with thyroidal dysfunction, excluding those assessed by the investigator that the disorder is controlled as appropriate by three-month or longer drug therapy
  • Participants with present or past history of rheumatoid arthritis, inflammatory arthritis, infectious arthritis, or auto immune disease rather than thyroid deficiency
  • Participants with an axis I condition according to DSM-IV, currently or within the past year, except for major depressive disorders
  • Participants with a lifetime diagnosis of bipolar disorder or schizoaffective disorder; or any other disorder with psychotic symptoms - based on the clinical opinion of the investigator
  • Participants with personality disorder or mental retardation
  • Participants with uncontrolled angle closure glaucoma
  • Participants with present or past history of uncontrolled seizures or convulsion disorders
  • Participants with suicidal ideation within past 6 months, with suicidal attempt within past 1 year
  • Participants answering "yes" to any of the questions about active suicidal ideation/intent/behaviors occurring within the past 6 months (Columbia Suicide Severity Rating Scale, Suicide Ideation section - Questions 4 and 5; Suicidal Behavior section)
  • Participants with past history of multiple episodes of drug allergy
  • Female participants who are pregnant, lactating, or who want to get pregnant during the study period. Male participants who want his partner to get pregnant
  • Females of child-bearing potential who can't agree to utilize medically acceptable and reliable means of birth control during the study and for 1 month following the last dose of the study
  • Participants with a history of alcohol or any psychoactive substance abuse or dependence (including alcohol, but excluding nicotine and caffeine) within the past 1 year
  • Participants who have a positive urine drug screen for any substance of abuse (phencyclidine, cocaine, antihypnotic agent, or cannabis).
  • Participants previously treated with duloxetine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552057

Locations
Japan
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.
Miyagi, Japan, 982-0032
Sponsors and Collaborators
Eli Lilly and Company
Shionogi
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01552057     History of Changes
Other Study ID Numbers: 14377, F1J-JE-HMGZ
Study First Received: March 9, 2012
Last Updated: January 16, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Duloxetine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on October 19, 2014