Clinical Trials Logo
  1. Home
  2. Fibromyalgia
  3. NCT00796601
  4. Details
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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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Status Withdrawn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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05659862 - Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT03042728 - Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program N/A
Recruiting NCT06097091 - Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia N/A
Recruiting NCT04554784 - Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia N/A
Completed NCT03300635 - Metabolism, Muscle Function and Psychological Factors in Fibromyalgia N/A
Recruiting NCT06166563 - Exercise, Irritable Bowel Syndrome and Fibromyalgia N/A
Completed NCT03227952 - Sensory Stimulation in Fibromyalgia N/A
Completed NCT03166995 - Postural Exercises in Women With Fibromyalgia N/A
Recruiting NCT06237595 - Vagus Nerve Stimulation in Fibromyalgia N/A
Completed NCT01888640 - Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST) N/A
Completed NCT03641495 - Pain Education and Therapeutic Exercise for Fibromyalgia N/A
Recruiting NCT05581628 - FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
Active, not recruiting NCT05128162 - Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia Phase 2
Completed NCT04674878 - Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia N/A
Active, not recruiting NCT04084795 - Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia N/A
Completed NCT03129906 - Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients N/A
Completed NCT05058911 - Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia N/A
Recruiting NCT04571528 - Effectiveness of VIRTUAL FIBROWALK STUDY N/A
Recruiting NCT04571853 - New Educational Tool for FM N/A

External Links