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NCT00796601 Clinical Trial

Maintenance of Efficacy.

Fibromyalgia Clinical Trial

Official title:
A 6-month, Double-blind, Placebo-controlled, Multi-center, Parallel Group, Maintenance Of Effect Study Of Esreboxetine (Pnu-165442g) Administered Once Daily (qd) In Patients With Fibromyalgia

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00796601
Other study ID # A6061054
Secondary ID A60610542008-006
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date May 1, 2009
Est. completion date November 1, 2010

Study information
Verified date November 2018
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at 3 and 6 months compared to placebo.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date November 1, 2010
Est. primary completion date May 1, 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subjects must meet the American College of Rheumatology (ACR) criteria for fibromyalgia

- Pain score greater than or equal to 4 on an 11-point NRS

- FIQ-Total score greater than or equal to 45 points

Exclusion Criteria:

- Other severe pain that may confound assessment or self evaluation of the pain associated with fibromyalgia

- Any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), clinically significant active infection, or untreated endocrine disorder

- Uncontrolled hypertension Pending Worker's Compensation; Current or recent diagnosis or episode of major depressive disorder, dysthymia and/or uncontrolled depression; Subjects to be at risk of suicide;

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Esreboxetine
Film coated tablets (2, 6, 8, 10 mg esreboxetine), once daily for 6 months
• Placebo
Film coated tablets (0 mg esreboxetine), once daily for 6 months

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline to 3 and 6 months in the mean daily pain rating score measured by the 11 point pain intensity Numerical Rating Scale (NRS). 6 months
Primary Change from baseline to 3 and 6 months in the FIQ-Total score 6 months
Secondary Pain (including other measures of daily pain and responder analyses); 6 months
Secondary Function (including sub-scales of the FIQ, responder analyses of FIQ and SF-36); 6 months
Secondary Global efficacy measures PGIC); 6 months
Secondary Sleep (MOS); 6 months
Secondary Work productivity; 6 months
Secondary Depression (HADS) 6 months
Secondary Safety (vital signs, ECG, laboratory, suicidal ideation) 6 months
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