Maintenance of Efficacy.

NCT00796601 | Withdrawn Phase 3 DMC

• 2 other identifiers: A60610542008-006760-10
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Fibromyalgia

Keywords

double-blind placebo-controlled maintenance of efficacy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Pain (including other measures of daily pain and responder analyses);

  6 months

• Function (including sub-scales of the FIQ, responder analyses of FIQ and SF-36);

  6 months

• Global efficacy measures PGIC);

  6 months

• Sleep (MOS);

  6 months

• Work productivity;

  6 months

Study Arms (2)

Esreboxetine

EXPERIMENTAL

Drug: Esreboxetine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Esreboxetine DRUG

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

Esreboxetine

Placebo DRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Fibromyalgia

Interventions

esreboxetine

Condition Hierarchy (Ancestors)

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 24, 2008
• Study Start: May 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 29, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share