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Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01773993
Recruitment Status : Completed
First Posted : January 23, 2013
Results First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
To collect the efficacy and safety information of Pregabalin on Fibromyalgia patients related to their appropriate use in daily practice.

Condition or disease Intervention/treatment
Pain Associated With Fibromyalgia Drug: Pregabalin

Detailed Description:
All the patients whom an investigator prescribes the first pregabalin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

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Study Type : Observational
Actual Enrollment : 534 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: SPECIAL INVESTIGATION OF PREGABALIN FOR FIBROMYALGIA
Actual Study Start Date : February 2013
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Pregabalin

Group/Cohort Intervention/treatment
Pregabalin
Subjects who are treated with pregabalin
Drug: Pregabalin
The usual adult dosage for oral use begins at 150 mg/day of pregabalin twice daily, and should be gradually increased to 300 mg/day over 1 week or more and then maintained at 300-450 mg/day as needed. Dosage should be adjusted, depending on age or symptoms. However, the daily maximum dose should not be beyond 450 mg, and should be orally administered twice daily.
Other Name: Lyrica® Capsules 25 mg, Lyrica® Capsules 75 mg, Lyrica® Capsules 150 mg




Primary Outcome Measures :
  1. Percentage of Participants With Adverse Drug Reaction [ Time Frame: From Week 1 to 52 weeks at maximum ]
    An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician.


Secondary Outcome Measures :
  1. Percentage of Participants With Serious Adverse Drug Reaction [ Time Frame: From Week 1 to52 weeks ]
    An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to LYRICA Capsules was assessed by the physician.

  2. Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert [ Time Frame: From Week 1 to 52 weeks ]
    An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to LYRICA Capsules was assessed by the physician.

  3. Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events [ Time Frame: From Week 1 to 52 weeks ]
    An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to peripheral edema or other edema-related events was evaluated.

  4. Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury [ Time Frame: From Week 1 to 52 weeks ]
    An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to dizziness, somnolence, loss of consciousness, syncope, and potential for accidental injury was evaluated.

  5. Number of Participants With Adverse Drug Reactions Related to Vision-related Events [ Time Frame: From Week 1 to 52 weeks ]
    An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to vision-related events was evaluated.

  6. Change From Baseline in Pain Score at Week 52 [ Time Frame: Baseline and at Week 52 ]
    The pain from fibromyalgia experienced during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no pain) to 10 (the most severe pain possible). Mean change from baseline in the pain score at Week 52 was presented along with standard deviation.

  7. Change From Baseline in Quality of Sleep Score at Week 52 [ Time Frame: Baseline and at Week 52 ]
    The quality of sleep experienced during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (the best sleep possible) to 10 (the worst sleep possible). Mean change from baseline in quality of sleep score at Week 52 was presented along with standard deviation.

  8. Patient's Impression (PGIC) at Week 52 [ Time Frame: At Week 52 ]
    The patient's impression (patient global impression of change [PGIC]) at Week 52, as compared to the baseline condition (including the first day of treatment), was rated by participants on a 7-grade scale.

  9. Physician's Impression (CGIC) at Week 52 [ Time Frame: At Week 52 ]
    The physician's impression (clinical global impression of change [CGIC]) at Week 52, as compared to the baseline condition (including the first day of treatment), was rated by the physician on a 7-grade scale.

  10. Change From Baseline in Patient Health Questionnaire (PHQ-9) Score at Week 52 [ Time Frame: Baseline and at Week 52 ]
    The problems associated with depression-related symptoms experienced during the last 2 weeks were rated by participants ranging from 0 (not at all) to 3 (nearly every day) in total 0 to 27(the higher the more severe) consisting the following 9 items: 1) little interest or pleasure in doing things; 2) depressed, or hopeless; 3) trouble falling or staying asleep, or sleeping too much; 4) feeling tired or having little energy; 5) poor appetite or overeating; 6) feeling bad about yourself - or that you are a failure or have let yourself or your family down; 7) trouble concentrating on things, such as reading the newspaper or watching television; 8) moving or speaking so slowly that other people could have noticed. Or the opposite - being so fidgety or restless that you have been moving around a lot more than usual; and 9) thoughts that you would be better off dead, or of hurting yourself. Mean change from baseline in the evaluation score was presented along with standard deviation.

  11. Change From Baseline in Health Status of EuroQol 5 Dimension (EQ-5D) at 52 Weeks [ Time Frame: Baseline and at Week 52 ]
    Health status (EQ-5D) was evaluated based on the following 5 dimensions: mobility, self-care, usual activity (e.g., work, study, housework, family, or leisure activities), pain/discomfort, and anxiety/depression. Each dimension was rated in the three levels of response alternatives "no problems," "some problems," or "extreme problems." For the analysis of EQ-5D, the response outcome for the five dimensions was converted to a utility value using tariff value set based on the Japanese version of EQ-5D. The utility value was not assigned if there was no response in any one of the five dimensions. 1 for full health and 0 for being dead: a positive (negative) number implies that the health state is better (worse) than dead. Mean change from baseline in the evaluation score was presented along with standard deviation.

  12. Change From Baseline in Fibromyalgia Activity Score (FAS-31) at 52 Weeks [ Time Frame: At Week 52 ]
    FAS-31 (ranged from 0 to 31) is calculated as the combined score of the widespread pain index (WPI, ranged from 0 to 19) and the symptom severity (SS) scale (ranged from 0 to 12). The WPI is a measure of the number of painful body regions. The SS is the scale of the severity in the three symptoms (fatigue, waking unrefreshed, and cognitive symptoms; ranged from 0 to 3 each) and general physical symptoms (ranged from 0 to 3). WPI ranged from 0 to 19 the higher score indicates more severe of activity, SS ranged from 0-12 also higher score shows more severe symptoms observed. Mean change from baseline in the evaluation score was presented along with standard deviation.

  13. Change From Baseline in the Japanese Version of the Revised Fibromyalgia Impact Questionnaire (JFIQR) at 52 Weeks [ Time Frame: At Week 52 ]
    JFIQR is a Japanese version of the Revised Fibromyalgia Impact Questionnaire (FIQR), which was established for overall evaluation of the influence of fibromyalgia on patient's health. It consists of three linked sets of domains: "function (9 questions)," "overall impact (2 questions)," and "symptoms (10 questions)." Participants responded to the questions based on an 11-grade scale, ranging from 0 to 10, with 10 being the worst. For the analysis of JFIQR, the score for each domain was modified as follows: The summed score for "function" (ranged from 0 to 90) was divided by 3 and the summed score for "symptoms" (ranged from 0 to 100) was divided by 2. The summed score for "overall impact" (ranged from 0 to 20) was not modified. The total score, the sum of the three modified domain scores (ranged from 0 to 100, the lower score represents a better outcome), was used for the analysis. Mean change from baseline in the evaluation score was presented along with standard deviation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic and hospital for Fibromyalgia
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Fibromyalgia
  • Pregabalin naive patient

Exclusion Criteria:

  • Clinical diagnosis of neuropathic pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773993


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] December 15, 2014
Statistical Analysis Plan  [PDF] March 9, 2018


Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01773993    
Other Study ID Numbers: A0081282
First Posted: January 23, 2013    Key Record Dates
Results First Posted: May 3, 2019
Last Update Posted: May 3, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Lyrica
pregabalin
Good post marketing practice
Post Marketing Surveillance
Regulatory Post Marketing Commitment Plan
Fibromyalgia
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs