A Study for Adult Patients With Fibromyalgia

NCT00965081 | Completed Phase 4 Results

• 2 other identifiers: 12873F1J-MC-HMGG
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 4

Brief Summary

The main purpose of this study is to determine if 30 milligrams (mg) of duloxetine is effective in the treatment of fibromyalgia compared to placebo.

Conditions

Fibromyalgia, Primary; Fibromyalgia, Secondary

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) "24-Hour Average Pain" Item (Question 3) of the BPI-Modified Short Form Score

  BPI Average Pain score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Treatment group difference in Least Squares (LS) Means changes from analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators, baseline. Baseline-observation-carried-forward (BOCF) method used to impute endpoint value for those who discontinued initial double-blind therapy (DBT) due to adverse event (AE); last non-missing observation during initial DBT used to impute missing endpoint for all others. Analyses included all participants having non-missing baseline and endpoint.

  Baseline, 12 weeks

Secondary Outcomes (8)

• Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form

  Baseline, 12 weeks

• Patient Global Impression - Improvement (PGI-I) at Endpoint

  12 weeks

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

  12 weeks

• Change From Baseline to 12-Week Endpoint Beck Depression Inventory-II (BDI-II)

  Baseline, 12 weeks

• Change From Baseline to 12-Week Endpoint Fibromyalgia Impact Questionnaire (FIQ)

  Baseline, 12 weeks

Study Arms (2)

Duloxetine

EXPERIMENTAL

Drug: Duloxetine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Duloxetine DRUG

30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks

Also known as: Cymbalta, LY248686

Duloxetine

Placebo DRUG

QD po at the same time each day for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet study criteria for fibromyalgia diagnosis.

You may not qualify if:

• Have previously or are currently taking duloxetine.
• Have been diagnosed with certain psychoses, bipolar or schizoaffective disorder
• Have pain symptoms that are difficult to differentiate from fibromyalgia.
• Have seizure disorder, uncontrolled narrow angle glaucoma, or acute liver injury (such as hepatitis) or severe cirrhosis.
• Have had any primary Axis 1 diagnosis other than major depressive disorder or generalized anxiety disorder within the past year.
• Are pregnant or breast-feeding
• Have a current or previous diagnosis of rheumatoid, infectious or inflammatory arthritis or an autoimmune disease
• Have a regional pain syndrome, failed back syndrome or chronic localized pan related to any past surgery
• Have a serious unstable medical illness
• Have a history of substance abuse or dependence within the past year

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (4)

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.

Guadalajara, 45040, Mexico

Location

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.

Mérida, 97000, Mexico

Location

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.

Monterrey, 64040, Mexico

Location

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.

Morelia, 58000, Mexico

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2009
• First Posted: August 25, 2009
• Study Start: September 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 3, 2011
• Results First Posted: November 3, 2011

Record last verified: 2011-09

Locations

ME (4)