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Trial record 1 of 1 for:    NCT01202227
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An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain

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: NCT01202227
Recruitment Status : Completed
First Posted : September 15, 2010
Results First Posted : May 17, 2013
Last Update Posted : May 17, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Spinal Cord Diseases
Spinal Cord Injuries
Neuralgia
Pain
Intervention Drug: pregabalin
Enrollment 104
Recruitment Details Japanese patients with central neuropathic pain after spinal cord injury who had completed the preceding A0081107 study (NCT00407745) were eligible for this study, and Japanese patients with pain after cerebral stroke or with multiple sclerosis pain were newly recruited.
Pre-assignment Details Participants who had joined A0081107 study (NCT00407745) were treated with pregabalin or placebo for 16 weeks and underwent tapering phase prior to this study.
Arm/Group Title Pregabalin
Hide Arm/Group Description Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
Period Title: Overall Study
Started 103 [1]
Completed 84
Not Completed 19
Reason Not Completed
Adverse Event             16
Withdrawal by Subject             2
Lack of Efficacy             1
[1]
Treated
Arm/Group Title Pregabalin
Hide Arm/Group Description Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
Overall Number of Baseline Participants 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 103 participants
>=18 and <45 years 15
>= 45 and <65 years 60
>=65 years 28
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants
Female
22
  21.4%
Male
81
  78.6%
1.Primary Outcome
Title Number of Participants With Peripheral Edema
Hide Description Number of participants who had peripheral edema in lower extremities. Edema was categorized as follows: trace, pitting 1 (lower leg), 2 (lower leg to knee), and 3 (above knee and /or presacral edema).
Time Frame Baseline, Weeks 4, 20, 36, 52, and 53
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: Participants
Trace at Baseline (n=103) 5
Pitting +1 at Baseline (n=103) 9
Pitting +2 at Baseline (n=103) 2
Pitting +3 at Baseline (n=103) 0
Trace at Week 4 (n=101) 8
Pitting +1 at Week 4 (n=101) 8
Pitting +2 at Week 4 (n=101) 4
Pitting +3 at Week 4 (n=101) 1
Trace at Week 20 (n=93) 8
Pitting +1 at Week 20 (n=93) 3
Pitting +2 at Week 20 (n=93) 7
Pitting +3 at Week 20 (n=93) 0
Trace at Week 36 (n=90) 14
Pitting +1 at Week 36 (n=90) 7
Pitting +2 at Week 36 (n=90) 3
Pitting +3 at Week 36 (n=90) 0
Trace at Week 52/early termination (n=100) 10
Pitting +1 at Week 52/early termination (n=100) 7
Pitting +2 at Week 52/early termination (n=100) 2
Pitting +3 at Week 52/early termination (n=100) 0
Trace at Week 53/early termination (n=78) 9
Pitting +1 at Week 53/early termination (n=78) 5
Pitting +2 at Week 53/early termination (n=78) 0
Pitting +3 at Week 53/early termination (n=78) 0
2.Primary Outcome
Title Number of Participants With Facial/Periorbital Edema
Hide Description Number of participants who had facial or periorbital edema.
Time Frame Baseline, Weeks 4, 20, 36, 52, and 53
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: Participants
Baseline (n=103) 0
Week 4 (n=101) 0
Week 20 (n=93) 0
Week 36 (n=90) 0
Week 52/early termination (n=100) 1
Week 53/early termination (n=78) 0
3.Primary Outcome
Title Number of Participants With Generalized or Abdominal Edema
Hide Description Number of participants who had generalized or abdominal edema.
Time Frame Baseline, Weeks 4, 20, 36, 52, and 53
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: Participants
Baseline (n=103) 0
Week 4 (n=101) 0
Week 20 (n=93) 0
Week 36 (n=90) 0
Week 52/early termination (n=100) 1
Week 53/early termination (n=78) 0
4.Primary Outcome
Title Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
Hide Description DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Time Frame Baseline, Weeks 4, 20, 36, 52, and 53
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: Participants
Mild at Baseline (n=103) 2
Moderate at Baseline (n=103) 3
Severe at Baseline (n=103) 1
Mild at Week 4 (n=101) 5
Moderate at Week 4 (n=101) 1
Severe at Week 4 (n=101) 0
Mild at Week 20 (n=93) 3
Moderate at Week 20 (n=93) 0
Severe at Week 20 (n=93) 0
Mild at Week 36 (n=90) 3
Moderate at Week 36 (n=90) 0
Severe at Week 36 (n=90) 0
Mild at Week 52/early termination (n=100) 3
Moderate at Week 52/early termination (n=100) 0
Severe at Week 52/early termination (n=100) 1
Mild at Week 53/early termination (n=78) 2
Moderate at Week 53/early termination (n=78) 1
Severe at Week 53/early termination (n=78) 0
5.Primary Outcome
Title Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
Hide Description DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Time Frame Baseline, Weeks 4, 20, 36, 52, and 53
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: Participants
Mild at Baseline (n=103) 0
Moderate at Baseline (n=103) 0
Severe at Baseline (n=103) 0
Mild at Week 4 (n=101) 0
Moderate at Week 4 (n=101) 0
Severe at Week 4 (n=101) 0
Mild at Week 20 (n=93) 0
Moderate at Week 20 (n=93) 0
Severe at Week 20 (n=93) 0
Mild at Week 36 (n=90) 0
Moderate at Week 36 (n=90) 0
Severe at Week 36 (n=90) 0
Mild at Week 52/early termination (n=100) 0
Moderate at Week 52/early termination (n=100) 0
Severe at Week 52/early termination (n=100) 0
Mild at Week 53/early termination (n=78) 0
Moderate at Week 53/early termination (n=78) 0
Severe at Week 53/early termination (n=78) 0
6.Primary Outcome
Title Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
Hide Description DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Time Frame Baseline, Weeks 4, 20, 36, 52, and 53
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: Participants
Mild at Baseline (n=103) 4
Moderate at Baseline (n=103) 2
Severe at Baseline (n=103) 0
Mild at Week 4 (n=101) 3
Moderate at Week 4 (n=101) 2
Severe at Week 4 (n=101) 0
Mild at Week 20 (n=93) 3
Moderate at Week 20 (n=93) 2
Severe at Week 20 (n=93) 0
Mild at Week 36 (n=90) 4
Moderate at Week 36 (n=90) 1
Severe at Week 36 (n=90) 0
Mild at Week 52/early termination (n=100) 7
Moderate at Week 52/early termination (n=100) 0
Severe at Week 52/early termination (n=100) 0
Mild at Week 53/early termination (n=78) 5
Moderate at Week 53/early termination (n=78) 0
Severe at Week 53/early termination (n=78) 0
7.Primary Outcome
Title Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
Hide Description DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Time Frame Baseline, Weeks 4, 20, 36, 52, and 53
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: Participants
Mild at Baseline (n=103) 6
Moderate at Baseline (n=103) 1
Severe at Baseline (n=103) 0
Mild at Week 4 (n=101) 5
Moderate at Week 4 (n=101) 2
Severe at Week 4 (n=101) 0
Mild at Week 20 (n=93) 4
Moderate at Week 20 (n=93) 1
Severe at Week 20 (n=93) 0
Mild at Week 36 (n=90) 7
Moderate at Week 36 (n=90) 0
Severe at Week 36 (n=90) 0
Mild at Week 52/early termination (n=100) 8
Moderate at Week 52/early termination (n=100) 0
Severe at Week 52/early termination (n=100) 0
Mild at Week 53/early termination (n=78) 4
Moderate at Week 53/early termination (n=78) 0
Severe at Week 53/early termination (n=78) 0
8.Primary Outcome
Title Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
Hide Description DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Time Frame Baseline, Weeks 4, 20, 36, 52, and 53
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: Participants
Mild at Baseline (n=103) 0
Moderate at Baseline (n=103) 0
Severe at Baseline (n=103) 0
Mild at Week 4 (n=101) 0
Moderate at Week 4 (n=101) 0
Severe at Week 4 (n=101) 0
Mild at Week 20 (n=93) 0
Moderate at Week 20 (n=93) 0
Severe at Week 20 (n=93) 0
Mild at Week 36 (n=90) 0
Moderate at Week 36 (n=90) 0
Severe at Week 36 (n=90) 0
Mild at Week 52/early termination (n=100) 0
Moderate at Week 52/early termination (n=100) 0
Severe at Week 52/early termination (n=100) 0
Mild at Week 53/early termination (n=78) 0
Moderate at Week 53/early termination (n=78) 0
Severe at Week 53/early termination (n=78) 0
9.Primary Outcome
Title Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
Hide Description DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Time Frame Baseline, Weeks 4, 20, 36, 52, and 53
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: Participants
Mild at Baseline (n=103) 0
Moderate at Baseline (n=103) 0
Severe at Baseline (n=103) 0
Mild at Week 4 (n=101) 0
Moderate at Week 4 (n=101) 0
Severe at Week 4 (n=101) 0
Mild at Week 20 (n=93) 1
Moderate at Week 20 (n=93) 0
Severe at Week 20 (n=93) 0
Mild at Week 36 (n=90) 0
Moderate at Week 36 (n=90) 0
Severe at Week 36 (n=90) 0
Mild at Week 52/early termination (n=100) 0
Moderate at Week 52/early termination (n=100) 0
Severe at Week 52/early termination (n=100) 0
Mild at Week 53/early termination (n=78) 0
Moderate at Week 53/early termination (n=78) 0
Severe at Week 53/early termination (n=78) 0
10.Primary Outcome
Title Number of Participants With Visual Field Deteriorated
Hide Description Number of participants who had normal visual field at baseline and showed abnormal result after the study treatment, assessed by confrontational visual field test (neurological examination).
Time Frame 53 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: Participants
Right eye 0
Left eye 0
11.Primary Outcome
Title Number of Participants With Deterioration in Neurological Examination Findings
Hide Description Worsening of the condition relative to baseline was reported as deteriorated. Assessment categories are as follows: normal or abnormal for Cranial Nerve Function, Mental State, and Coordination; normal, mild, moderate, or severe ataxia for Gait; none/absent, normal, or hyper-reflexic for Deep Tendon Reflexes; absent or present for Abnormal Reflexes; normal, mild, moderate, or severe weakness for Muscle Strength; slight, more marked, or considerable increase, or affected parts rigid in flexion or extension for Muscle Tone; absent or present for Sensory Function.
Time Frame 53 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: Participants
Cranial Nerve Function 0
Mental State 0
Coordination: Right (R)- Finger to Nose 0
Coordination: Left (L)- Finger to Nose 2
Coordination: R- Finger Tapping 1
Coordination: L- Finger Tapping 0
Coordination: R- Rapid Alternating Hand Movement 1
Coordination: L- Rapid Alternating Hand Movement 2
Coordination: Romberg Test 1
Gait 1
Deep Tendon Reflexes: R- Brachioradialis 1
Deep Tendon Reflexes: L- Brachioradialis 1
Deep Tendon Reflexes: R-Patellar 3
Deep Tendon Reflexes: L-Patellar 3
Deep Tendon Reflexes: R- Achilles 2
Deep Tendon Reflexes: L- Achilles 3
Abnormal Reflexes 1
Muscle Strength: R- Upper Limb 1
Muscle Strength: L- Upper Limb 2
Muscle Strength: R- Lower Limb 1
Muscle Strength: L- Lower Limb 2
Muscle Tone: R- Upper Limb 1
Muscle Tone: L- Upper Limb 1
Muscle Tone: R- Lower Limb 5
Muscle Tone: L- Lower Limb 5
Sensory Function: Anesthesia 0
Sensory Function: Hypesthesia 1
Sensory Function: Allodynia 1
Sensory Function: Hyperalgesia 2
12.Primary Outcome
Title Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)
Hide Description The Sheehan-STS is an 8-item prospective rating scale that tracks treatment-emergent suicidal ideation and behaviors. Participants who reported a score of ≥1 (5-point scale ranging from 0: not at all to 4: extremely) for Item 2, 3, 4 or 5 of the Sheehan-STS prognostic scale is considered to have suicidal ideation as the scores are mapped to Category 4 (suicide ideation) of the Columbia Classification Algorithm of Suicide Assessment.
Time Frame Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: Participants
Baseline (n=103) 3
Week 2 (n=102) 2
Week 4 (n=101) 1
Week 8 (n=99) 0
Week 12 (n=96) 0
Week 20 (n=93) 2
Week 28 (n=91) 2
Week 36 (n=90) 2
Week 44 (n=85) 2
Week 52 (n=101) 0
13.Secondary Outcome
Title Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores
Hide Description

The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.

Range: 0 to 45 for total score. Change = observation mean minus baseline mean. Negative change indicated improvement.

Time Frame Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. For study endpoint of efficacy (Week 52), missing values was imputed with the last observation carried forward (LOCF).
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
Overall Number of Participants Analyzed 103
Mean (95% Confidence Interval)
Unit of Measure: Score on a scale
Week 2 (n=103)
-4.2
(-5.4 to -3.0)
Week 4 (n=102)
-5.2
(-6.4 to -4.0)
Week 8 (n=99)
-5.3
(-6.6 to -4.0)
Week 12 (n=98)
-5.7
(-7.3 to -4.2)
Week 20 (n=95)
-6.1
(-7.6 to -4.7)
Week 28 (n=92)
-5.1
(-6.6 to -3.6)
Week 36 (n=91)
-5.0
(-6.5 to -3.5)
Week 44 (n=87)
-4.4
(-6.1 to -2.8)
Week 52 (n=85)
-5.0
(-6.6 to -3.4)
Week 52 (LOCF, n=103)
-4.6
(-6.2 to -3.0)
14.Secondary Outcome
Title Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores
Hide Description

The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.

Range: 0 to 33 for sensory score. Change = observation mean minus baseline mean. Negative change indicated improvement.

Time Frame Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. For study endpoint of efficacy (Week 52), missing values was imputed with the last observation carried forward (LOCF).
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
Overall Number of Participants Analyzed 103
Mean (95% Confidence Interval)
Unit of Measure: Score on a scale
Week 2 (n=103)
-3.1
(-4.1 to -2.2)
Week 4 (n=102)
-3.9
(-4.8 to -3.0)
Week 8 (n=99)
-3.9
(-4.9 to -3.0)
Week 12 (n=98)
-4.2
(-5.4 to -3.1)
Week 20 (n=95)
-4.5
(-5.6 to -3.4)
Week 28 (n=92)
-3.8
(-5.0 to -2.7)
Week 36 (n=91)
-3.7
(-4.8 to -2.6)
Week 44 (n=87)
-3.1
(-4.4 to -1.9)
Week 52 (n=85)
-3.6
(-4.8 to -2.4)
Week 52 (LOCF, n=103)
-3.6
(-4.8 to -2.4)
15.Secondary Outcome
Title Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores
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The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.

Range: 0 to 12 for affective score. Change = observation mean minus baseline mean. Negative change indicated improvement.

Time Frame Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
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Hide Analysis Population Description
The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. For study endpoint of efficacy (Week 52), missing values was imputed with the last observation carried forward (LOCF).
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
Overall Number of Participants Analyzed 103
Mean (95% Confidence Interval)
Unit of Measure: Score on a scale
Week 2 (n=103)
-1.1
(-1.5 to -0.5)
Week 4 (n=102)
-1.3
(-1.7 to -0.8)
Week 8 (n=99)
-1.3
(-1.8 to -0.9)
Week 12 (n=98)
-1.5
(-2.0 to -1.0)
Week 20 (n=95)
-1.6
(-2.1 to -1.2)
Week 28 (n=92)
-1.3
(-1.8 to -0.9)
Week 36 (n=91)
-1.3
(-1.8 to -0.7)
Week 44 (n=87)
-1.3
(-1.9 to -0.7)
Week 52 (n=85)
-1.4
(-1.9 to -0.9)
Week 52 (LOCF, n=103)
-1.0
(-1.5 to -0.5)
16.Secondary Outcome
Title Change From Baseline in the Modified Brief Pain Inventory (10 Item) (mBPI-10)Total Scores at Last Evaluation Score
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The mBPI-10 is a self administered questionnaire that assesses pain interference with functional activities over the past week. These items are measured on an 11 point scale, ranging from "does not interfere" (0) to "completely interferes" (10). A composite score, the Pain Interference Index, will be calculated by averaging the 10 items that comprise the scale.

Change = observation mean at Week 52 minus baseline mean.

Time Frame Baseline, Week 52
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The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available.

The number of participants who had mBPI at Week 52/ Early Termination was 101 participants (n=101).

Arm/Group Title Pregabalin
Hide Arm/Group Description:
Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
Overall Number of Participants Analyzed 103
Mean (95% Confidence Interval)
Unit of Measure: Score on a scale
-1.4
(-1.9 to -0.9)
Time Frame 53 weeks
Adverse Event Reporting Description 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.
 
Arm/Group Title Pregabalin
Hide Arm/Group Description Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
All-Cause Mortality
Pregabalin
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Pregabalin
Affected / at Risk (%)
Total   19/103 (18.45%) 
Cardiac disorders   
Arteriosclerosis coronary artery  1  1/103 (0.97%) 
Gastrointestinal disorders   
Anal fistula  1  1/103 (0.97%) 
Colonic polyp  1  1/103 (0.97%) 
Inguinal hernia  1  1/103 (0.97%) 
Melaena  1  1/103 (0.97%) 
Tooth development disorder  1  1/103 (0.97%) 
Hepatobiliary disorders   
Cholangitis acute  1  1/103 (0.97%) 
Infections and infestations   
Cellulitis  1  2/103 (1.94%) 
Infected skin ulcer  1  1/103 (0.97%) 
Pneumonia  1  1/103 (0.97%) 
Sepsis  1  1/103 (0.97%) 
Urinary tract infection  1  1/103 (0.97%) 
Injury, poisoning and procedural complications   
Femur fracture  1  1/103 (0.97%) 
Mucosal excoriation  1  1/103 (0.97%) 
Nervous system disorders   
Cerebral haemorrhage  1  1/103 (0.97%) 
Cerebral infarction  1  2/103 (1.94%) 
Transient ischaemic attack  1  1/103 (0.97%) 
Psychiatric disorders   
Psychotic disorder  1  1/103 (0.97%) 
Respiratory, thoracic and mediastinal disorders   
Nasal polyps  1  1/103 (0.97%) 
Skin and subcutaneous tissue disorders   
Ingrowing nail  1  1/103 (0.97%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pregabalin
Affected / at Risk (%)
Total   91/103 (88.35%) 
Eye disorders   
Visual acuity reduced  1  7/103 (6.80%) 
Gastrointestinal disorders   
Constipation  1  8/103 (7.77%) 
General disorders   
Feeling abnormal  1  7/103 (6.80%) 
Oedema peripheral  1  18/103 (17.48%) 
Thirst  1  7/103 (6.80%) 
Infections and infestations   
Nasopharyngitis  1  26/103 (25.24%) 
Injury, poisoning and procedural complications   
Contusion  1  8/103 (7.77%) 
Fall  1  13/103 (12.62%) 
Investigations   
Weight increased  1  31/103 (30.10%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  8/103 (7.77%) 
Nervous system disorders   
Dizziness  1  24/103 (23.30%) 
Hypoaesthesia  1  6/103 (5.83%) 
Somnolence  1  53/103 (51.46%) 
Skin and subcutaneous tissue disorders   
Eczema  1  7/103 (6.80%) 
Rash  1  8/103 (7.77%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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.
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.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01202227    
Other Study ID Numbers: A0081252
First Submitted: August 31, 2010
First Posted: September 15, 2010
Results First Submitted: January 10, 2013
Results First Posted: May 17, 2013
Last Update Posted: May 17, 2013