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A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression

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NCT01432236

Last updated on December 5, 2018
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FOR MORE INFORMATION
Study Location
Genova Clinical Research
Tucson, Arizona, 85704 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fibromyalgia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men or women of any race or ethnicity who are at least 18 years of age.

- Adult women and men with a diagnosis of fibromyalgia and stable depression (major
depressive disorder, depression not otherwise specified (NOS), or dysthymia) who have
been taking an antidepressant (SSRI or SNRI) primarily for their depression for at
least 3 months.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Have failed pregabalin treatment due to lack of improvement of symptoms at doses of
greater than or equal to 300 mg daily, cannot tolerate pregabalin or any pregabalin
ingredient, or participated in a pregabalin clinical trial. If the subject has taken
pregabalin and discontinued for reason other than lack of improvement or intolerance,
then they will be eligible. Pregabalin use within the last 30 days (prior to V1) is
not permitted.

- Patients with severe or unstable depression are not eligible.

- Patients with other types of pain or conditions that may make it difficult to evaluate
fibromyalgia symptoms are not eligible

- Any subject considered at risk of suicide or self harm based on investigator judgment
and/or the details of a risk assessment

NCT01432236
Pfizer
Completed
A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression

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[email protected]

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A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression
A Phase 3b Multicenter, Double-blind, Randomized, Placebo-controlled, 2-way Crossover Study Of Pregabalin In The Treatment Of Fibromyalgia With Concurrent Antidepressant Therapy For Comorbid Depression (Protocol A0081275)
The intent of this study is to identify and treat fibromyalgia subjects with comorbid depression who are receiving an SSRI (selective serotonin reuptake inhibitor) or SNRI (selective norepinephrine reuptake inhibitor) primarily for their depression and to determine whether pregabalin demonstrates improvement relative to placebo in improving pain associated with fibromyalgia.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fibromyalgia
  • Drug: Pregabalin
    Pregabalin 300 or 450 mg/day dosed BID ( twice a day) for 14 weeks; 150 mg/day starting dose
  • Drug: placebo
    placebo capsules twice a day for 14 weeks
  • Experimental: Pregabalin
    Group 1 as Pregabalin vs. Placebo (cross over study in which period one has this group)
    Intervention: Drug: Pregabalin
  • Placebo Comparator: Placebo
    Group 2 as placebo vs. pregabalin (cross over study in which period two will have this group)
    Intervention: Drug: placebo


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
197
July 2013
July 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men or women of any race or ethnicity who are at least 18 years of age.
  • Adult women and men with a diagnosis of fibromyalgia and stable depression (major depressive disorder, depression not otherwise specified (NOS), or dysthymia) who have been taking an antidepressant (SSRI or SNRI) primarily for their depression for at least 3 months.

Exclusion Criteria:

  • Have failed pregabalin treatment due to lack of improvement of symptoms at doses of greater than or equal to 300 mg daily, cannot tolerate pregabalin or any pregabalin ingredient, or participated in a pregabalin clinical trial. If the subject has taken pregabalin and discontinued for reason other than lack of improvement or intolerance, then they will be eligible. Pregabalin use within the last 30 days (prior to V1) is not permitted.
  • Patients with severe or unstable depression are not eligible.
  • Patients with other types of pain or conditions that may make it difficult to evaluate fibromyalgia symptoms are not eligible
  • Any subject considered at risk of suicide or self harm based on investigator judgment and/or the details of a risk assessment
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Italy,   Spain,   United States
 
 
NCT01432236
A0081275
2011-002480-19 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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