A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01432236
First received: September 8, 2011
Last updated: May 30, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fibromyalgia |
Drug: Pregabalin Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Endpoint mean pain score, based on the mean of the last 7 daily pain NRS scores from the daily pain diaries [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Subjective Sleep Questionnaire (daily diary; 5 questions) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: Visits 2, 6, and 12 ] [ Designated as safety issue: No ]
- Patient Global Impression of Change (PGIC) [ Time Frame: Visits 6 and 12 ] [ Designated as safety issue: No ]
- Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Visits 1, 2, 6 and `12 ] [ Designated as safety issue: Yes ]
- EuroQoL 5 Dimensions (EQ 5D) [ Time Frame: Visits 2, 6, and 12 ] [ Designated as safety issue: No ]
- Patient Static Global Assessment (PSGA) [ Time Frame: Visits 2, 6, and 12 ] [ Designated as safety issue: No ]
- Columbia Suicide Severity Rating Scale (C SSRS). [ Time Frame: Visits 1-14 ] [ Designated as safety issue: Yes ]
- Work Productivity and Activity Index Specific Health Problem (WPAI SHP) [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
- Health Utilization Assessment [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 140 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pregabalin
Group 1 as Pregabalin vs. Placebo (cross over study in which period one has this group)
|
Drug: Pregabalin
Pregabalin 300 or 450 mg/day dosed BID ( twice a day) for 14 weeks; 150 mg/day starting dose
|
|
Placebo Comparator: Placebo
Group 2 as placebo vs. pregabalin (cross over study in which period two will have this group)
|
Drug: placebo
placebo capsules twice a day for 14 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432236
Show 39 Study Locations
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Show 39 Study LocationsSponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01432236 History of Changes |
| Other Study ID Numbers: | A0081275 |
| Study First Received: | September 8, 2011 |
| Last Updated: | May 30, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Pregabalin Lyrica depression |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Fibromyalgia Myofascial Pain Syndromes Behavioral Symptoms Mood Disorders Mental Disorders Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases |
Nervous System Diseases Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on June 18, 2013