Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00264875

First received: December 12, 2005

Last updated: March 20, 2009

Last verified: March 2009

History of Changes

Results First Received: February 20, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Peripheral Neuropathy HIV Infections
Intervention:	Drug: pregabalin

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
With completion of A0081066 (NCT00232141), subjects had option of initiating treatment with pregabalin under open-label conditions for 3 months in A0081095, an open-label extension trial. Treatment in A0081095 was initiated on the evening of the subjects’ Visit 7/Termination Visit in A0081066. A0081095 was conducted in the United States.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Pregabalin	Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).

Participant Flow: Overall Study

	Pregabalin
STARTED	220
COMPLETED	190
NOT COMPLETED	30
Adverse Event	6
Lost to Follow-up	6
Protocol Violation	11
Withdrawal by Subject	7

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Pregabalin	Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).

Baseline Measures

	Pregabalin
Number of Participants [units: participants]	220
Age [units: years] Mean ± Standard Deviation	48.3 ± 7.8
Gender [units: participants]
Female	42
Male	178

Outcome Measures

1. Primary:

Mean Visual Analogue Scale (VAS) Pain Scores [ Time Frame: Baseline, Week 4, Week 8, Week 12, and Endpoint ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
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Frequency Threshold

Threshold above which other adverse events are reported	>2%

Reporting Groups

	Description
Pregabalin	Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).

Other Adverse Events

	Pregabalin
Total, other (not including serious) adverse events
# participants affected	82
Gastrointestinal disorders
Diarrhea ^{† 1}
# participants affected / at risk	12/220 (5.45%)
Dry mouth ^{† 1}
# participants affected / at risk	7/220 (3.18%)
Vomiting ^{† 1}
# participants affected / at risk	7/220 (3.18%)
Nausea ^{† 1}
# participants affected / at risk	6/220 (2.73%)
General disorders
Peripheral edema ^{† 1}
# participants affected / at risk	13/220 (5.91%)
Fatigue ^{† 1}
# participants affected / at risk	11/220 (5.00%)
Infections and infestations
Upper respiratory tract infection ^{† 1}
# participants affected / at risk	5/220 (2.27%)
Musculoskeletal and connective tissue disorders
Pain in extremity ^{† 1}
# participants affected / at risk	7/220 (3.18%)
Back pain ^{† 1}
# participants affected / at risk	6/220 (2.73%)
Nervous system disorders
Dizziness ^{† 1}
# participants affected / at risk	22/220 (10.00%)
Somnolence ^{† 1}
# participants affected / at risk	21/220 (9.55%)
Headache ^{† 1}
# participants affected / at risk	8/220 (3.64%)
Psychiatric disorders
Euphoric mood ^{† 1}
# participants affected / at risk	8/220 (3.64%)
Respiratory, thoracic and mediastinal disorders
Cough ^{† 1}
# participants affected / at risk	7/220 (3.18%)
Pharyngolaryngeal pain ^{† 1}
# participants affected / at risk	5/220 (2.27%)
Skin and subcutaneous tissue disorders
Rash ^{† 1}
# participants affected / at risk	5/220 (2.27%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA v11.0

Limitations and Caveats

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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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