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A Study of Duloxetine in Fibromyalgia

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fibromyalgia

Intervention: Duloxetine 60 mg (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

Summary

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

Clinical Details

Official title: A Phase III Clinical Trial of Duloxetine in Participants With Fibromyalgia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Change From Baseline to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)

Change From Baseline to 2 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)

Change From Baseline to 4 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)

Change From Baseline to 6 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)

Change From Baseline to 10 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)

Change From Baseline up to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (ANCOVA)

Secondary outcome:

Patients Global Impression of Improvement (PGI-I) at Endpoint

Clinical Global Impression of Improvement (CGI-I) at Endpoint

Change From Baseline to 14-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)

Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores

Change From Baseline to 14-Week Endpoint in Beck Depression Inventory-II (BDI-II)

Change From Baseline to 14-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010

Change From Baseline to 14-Week Endpoint in Average Pain and Worst Pain Severity Score Within 24-Hours in Participant Diary

Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form

Eligibility

Minimum age: 20 Years. Maximum age: 74 Years. Gender(s): Both.

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 Brief Pain Inventory (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 international units per liter (IU/L) or total bilirubin of not less than 1. 6 milligrams per deciliter (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 3-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 Diagnostic and Statistical Manual

of Mental Disorders Fourth Edition (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

Locations and Contacts

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 982-0032, Japan
Additional Information

Starting date: March 2012
Last updated: January 7, 2015

Page last updated: August 20, 2015

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