Maintenance of Efficacy.

• ClinicalTrials.gov Identifier: NCT00796601
• Recruitment Status: Withdrawn
• First Posted: November 24, 2008
• Last Update Posted: November 29, 2018
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: November 20, 2008
• First Posted Date: November 24, 2008
• Last Update Posted Date: November 29, 2018
• Actual Study Start Date: May 1, 2009
• Estimated Primary Completion Date: May 1, 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 21, 2008)

• 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). [ Time Frame: 6 months ]
• Change from baseline to 3 and 6 months in the FIQ-Total score [ Time Frame: 6 months ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 21, 2008)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Maintenance of Efficacy.
• 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
• Brief Summary: The hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at 3 and 6 months compared to placebo.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Fibromyalgia

Intervention

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

Study Arms

• Experimental: Esreboxetine
  Intervention: Drug: Esreboxetine
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: November 27, 2018): 0
• Original Estimated Enrollment (submitted: November 21, 2008): 650
• Estimated Study Completion Date: November 1, 2010
• Estimated Primary Completion Date: May 1, 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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;

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Korea, Republic of, Netherlands, Norway

Administrative Information

• NCT Number: NCT00796601
• Other Study ID Numbers: A6061054; A6061054; 2008-006760-10 ( EudraCT Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: November 2018