A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00830128

First received: January 26, 2009

Last updated: April 2, 2012

Last verified: April 2012

History of Changes

Results First Received: January 23, 2012

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Fibromyalgia
Intervention:	Drug: pregabalin (Lyrica)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants received the study drug in the precedent study A0081208 (NCT00830167).

Reporting Groups

	Description
Pregabalin	Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.

Participant Flow: Overall Study

	Pregabalin
STARTED	106
COMPLETED	87
NOT COMPLETED	19
Adverse Event	5
Lack of Efficacy	7
Protocol Violation	1
Withdrawal by Subject	2
Family obligation	1
Relocation	1
Work obligation	1
Operating a vehicle	1

Baseline Characteristics

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Reporting Groups

	Description
Pregabalin	Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.

Baseline Measures

	Pregabalin
Number of Participants [units: participants]	106
Age, Customized [units: Participants]
<18 years	0
Between 18 and 44 years	47
Between 45 and 64 years	49
>= 65 years	10
Gender [units: Participants]
Female	89
Male	17

Outcome Measures

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1. Primary:

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 53 weeks ]

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2. Secondary:

Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint [ Time Frame: Baseline, Week 52 or Study Discontinuation ]

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3. Secondary:

Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance at Endpoint [ Time Frame: Baseline, Week 52 or Study Discontinuation ]

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4. Secondary:

Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Snoring at Endpoint [ Time Frame: Baseline, Week 52 or Study Discontinuation ]

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5. Secondary:

Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Awaken Short of Breath or With a Headache at Endpoint [ Time Frame: Baseline, Week 52 or Study Discontinuation ]

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6. Secondary:

Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Adequacy at Endpoint [ Time Frame: Baseline, Week 52 or Study Discontinuation ]

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7. Secondary:

Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Quantity of Sleep at Endpoint [ Time Frame: Baseline, Week 52 or Study Discontinuation ]

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8. Secondary:

Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Somnolence at Endpoint [ Time Frame: Baseline, Week 52 or Study Discontinuation ]

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9. Secondary:

Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Overall Sleep Problems Index at Endpoint [ Time Frame: Baseline, Week 52 or Study Discontinuation ]

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10. Secondary:

Medical Outcomes Study (MOS) Sleep Scale - Optimal Sleep at Endpoint [ Time Frame: Week 52 or Study Discontinuation ]

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11. Secondary:

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Total Scores at Endpoint [ Time Frame: Baseline, Week 52 or Study Discontinuation ]

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12. Secondary:

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint [ Time Frame: Baseline, Week 52 or Study Discontinuation ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00830128 History of Changes
Other Study ID Numbers:	A0081209
Study First Received:	January 26, 2009
Results First Received:	January 23, 2012
Last Updated:	April 2, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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