Trial Outcomes & Findings for A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia (NCT NCT00424372)

NCT ID: NCT00424372

Last Updated: 2021-08-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 126 participants
• Primary outcome timeframe: 52 weeks
• Results posted on: 2021-08-27

Participant Flow

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.

Participant milestones

Measure	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).
Overall Study STARTED	126
Overall Study COMPLETED	95
Overall Study NOT COMPLETED	31

Reasons for withdrawal

Measure	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).
Overall Study Death	1
Overall Study Adverse Event	18
Overall Study Lack of Efficacy	6
Overall Study Withdrawal by Subject	4
Overall Study Protocol Violation	1
Overall Study Health deterioration	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Pregabalin n=126 Participants 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).
Age, Customized >= 18 and < 45 years	1 Subjects n=5 Participants
Age, Customized >= 45 and < 65 years	19 Subjects n=5 Participants
Age, Customized >=65 years	106 Subjects n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants
Sex: Female, Male Male	71 Participants n=5 Participants

PRIMARY outcome

Timeframe: 52 weeks

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

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.

Outcome measures

Measure	Pregabalin n=126 Participants 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).
Summary of Adverse Events Subjects with adverse events	124 subjects
Summary of Adverse Events Subjects with serious adverse events	14 subjects
Summary of Adverse Events Subjects with severe adverse events	5 subjects
Summary of Adverse Events Subjects discontinued due to adverse events	17 subjects
Summary of Adverse Events Dose reduced or temporary discontinuation	34 subjects

SECONDARY outcome

Timeframe: 52 weeks

Population: Full Analysis Set, N = Number of subjects assessed

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.

Outcome measures

Measure	Pregabalin n=126 Participants 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).
Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score Baseline	11.3 score on scale Standard Deviation 7.0
Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score Week 52	5.1 score on scale Standard Deviation 5.6
Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score Endpoint	6.7 score on scale Standard Deviation 7.1
Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score Change from Baseline to Endpoint	-4.8 score on scale Standard Deviation 5.9

SECONDARY outcome

Timeframe: 52 weeks

Population: Full Analysis Set, N = Number of subjects assessed

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.

Outcome measures

Measure	Pregabalin n=126 Participants 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).
Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score Baseline	3.4 score on scale Standard Deviation 3.1
Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score Week 52	1.0 score on scale Standard Deviation 1.8
Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score Endpoint	1.7 score on scale Standard Deviation 2.7
Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score Change from Baseline to Endpoint	-1.8 score on scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: 52 weeks

Population: Full Analysis Set, N = Number of subjects assessed

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.

Outcome measures

Measure	Pregabalin n=126 Participants 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).
Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score Baseline	14.7 score on scale Standard Deviation 9.7
Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score Week 52	6.1 score on scale Standard Deviation 7.2
Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score Endpoint	8.2 score on scale Standard Deviation 9.6
Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score Change from Baseline to Endpoint	-6.5 score on scale Standard Deviation 8.4

SECONDARY outcome

Timeframe: 52 weeks

Population: Full Analysis Set, N = Number of subjects assessed

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.

Outcome measures

Measure	Pregabalin n=126 Participants 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).
Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity Endpoint	1.7 score on scale Standard Deviation 1.1
Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity Change from Baseline to Endpoint	-1.1 score on scale Standard Deviation 1.1
Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity Baseline	2.8 score on scale Standard Deviation 1.0
Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity Week 52	1.4 score on scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 52 weeks

Population: Full Analysis Set, N = Number of subjects assessed

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.

Outcome measures

Measure	Pregabalin n=126 Participants 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).
Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale Baseline	62.0 mm Standard Deviation 19.0
Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale Week 52	28.3 mm Standard Deviation 22.9
Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale Endpoint	33.7 mm Standard Deviation 25.6
Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale Change from Baseline to Endpoint	-28.3 mm Standard Deviation 23.8

Adverse Events

Pregabalin

Serious events: 15 serious events

Other events: 98 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pregabalin n=126 participants at risk 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).
Cardiac disorders Atrial fibrillation	0.79% 1/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiac failure congestive	0.79% 1/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Vertigo	0.79% 1/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastroduodenal ulcer	0.79% 1/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	0.79% 1/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	0.79% 1/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Heat stroke	0.79% 1/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Joint dislocation	0.79% 1/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Open fracture	0.79% 1/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Radius fracture	0.79% 1/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Spinal compression fracture	1.6% 2/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Occult blood	0.79% 1/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.79% 1/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.79% 1/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	0.79% 1/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	0.79% 1/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Completed suicide	0.79% 1/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Asthma	0.79% 1/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.79% 1/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Emphysema	0.79% 1/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.79% 1/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant palate neoplasm	0.79% 1/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Measure	Pregabalin n=126 participants at risk 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).
Eye disorders Retinal haemorrhage	5.6% 7/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Visual acuity reduced	5.6% 7/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	9.5% 12/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	9.5% 12/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	5.6% 7/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	17.5% 22/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	27.0% 34/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fall	7.1% 9/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Weight increased	15.1% 19/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 7/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Osteoarthritis	5.6% 7/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	28.6% 36/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	5.6% 7/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Somnolence	17.5% 22/126 • 52 weeks The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

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Phone: 1-800-718-1021

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Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER