Maintenance of Efficacy.

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00796601

Enrollment

Registered

2008-11-24

Start date

2009-05-01

Completion date

2010-11-01

Last updated

2018-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

double-blind placebo-controlled maintenance of efficacy

Brief summary

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

Interventions

DRUGEsreboxetine

Film coated tablets (2, 6, 8, 10 mg esreboxetine), once daily for 6 months

DRUGPlacebo

Film coated tablets (0 mg esreboxetine), once daily for 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame
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
Change from baseline to 3 and 6 months in the FIQ-Total score	6 months

Secondary

Measure	Time frame
Global efficacy measures PGIC);	6 months
Sleep (MOS);	6 months
Pain (including other measures of daily pain and responder analyses);	6 months
Depression (HADS)	6 months
Safety (vital signs, ECG, laboratory, suicidal ideation)	6 months
Work productivity;	6 months
Function (including sub-scales of the FIQ, responder analyses of FIQ and SF-36);	6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026