A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia

A LONG-TERM STUDY TO EVALUATE SAFETY AND EFFICACY STUDY OF PREGABALIN IN THE TREATMENT OF POSTHERPETIC NEURALGIA.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00424372

Enrollment

126

Registered

2007-01-19

Start date

2007-01-12

Completion date

2008-08-19

Last updated

2021-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuralgia, Postherpetic

Brief summary

To evaluate the safety of the long-term use of pregabalin.

Interventions

DRUGpregabalin

Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks

Study design

Allocation

NON_RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients who completed the 13-week treatment of postherpetic neuralgia in Study A0081120. * Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study.

Exclusion criteria

* Patients who experienced serious adverse events in the preceding study (A0081120) that were determined by the investigator or the study sponsor to be causally related to the study medication. * Patients exhibiting treatment non-compliance in the preceding study (A0081120)

Design outcomes

Primary

Measure	Time frame	Description
Summary of Adverse Events	52 weeks	Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects are counted only once per treatment in each row.

Secondary

Measure	Time frame	Description
Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score	52 weeks	Score ranges: 0-33. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit \<= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score	52 weeks	Score ranges: 0-12. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit \<= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score	52 weeks	Score ranges: 0-45. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit \<= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity	52 weeks	Score ranges: 0-5. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit \<= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale	52 weeks	Ranges: 0-100 mm. Larger scale indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit \<= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.

Countries

Japan

Participant flow

Pre-assignment details

A total of 126 subjects who completed the 13-week treatment regimen in the preceding double-blind Study A0081120 and had no serious adverse events or issues with compliance were enrolled to this study.

Participants by arm

Arm	Count
Pregabalin Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects' safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 \< CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr \> 60 mL/min).	126
Total	126

Arm

Count

Pregabalin

Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects' safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 \< CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr \> 60 mL/min).

126

Total

126

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	18
Overall Study	Death	1
Overall Study	Health deterioration	1
Overall Study	Lack of Efficacy	6
Overall Study	Protocol Violation	1
Overall Study	Withdrawal by Subject	4

Baseline characteristics

Characteristic	Pregabalin
Age, Customized >= 18 and < 45 years	1 Subjects
Age, Customized >= 45 and < 65 years	19 Subjects
Age, Customized >=65 years	106 Subjects
Sex: Female, Male Female	55 Participants
Sex: Female, Male Male	71 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	98 / 126
serious Total, serious adverse events	15 / 126

Outcome results

Primary

Summary of Adverse Events

Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects are counted only once per treatment in each row.

Time frame: 52 weeks

Population: Safety population: all subjects who took at least 1 dose of study medication.

Arm	Measure	Group	Value (NUMBER)
Pregabalin	Summary of Adverse Events	Subjects discontinued due to adverse events	17 subjects
Pregabalin	Summary of Adverse Events	Subjects with severe adverse events	5 subjects
Pregabalin	Summary of Adverse Events	Subjects with adverse events	124 subjects
Pregabalin	Summary of Adverse Events	Subjects with serious adverse events	14 subjects
Pregabalin	Summary of Adverse Events	Dose reduced or temporary discontinuation	34 subjects

Secondary

Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score

Score ranges: 0-12. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit \<= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.

Time frame: 52 weeks