Trial Outcomes & Findings for An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain (NCT NCT01202227)
NCT ID: NCT01202227
Last Updated: 2021-01-28
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
104 participants
Primary outcome timeframe
Baseline, Weeks 4, 20, 36, 52, and 53
Results posted on
2021-01-28
Participant Flow
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.
Participants who had joined A0081107 study (NCT00407745) were treated with pregabalin or placebo for 16 weeks and underwent tapering phase prior to this study.
Participant milestones
| Measure |
Pregabalin
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 Study
STARTED
|
103
|
|
Overall Study
COMPLETED
|
84
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Pregabalin
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 Study
Adverse Event
|
16
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain
Baseline characteristics by cohort
| Measure |
Pregabalin
n=103 Participants
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.
|
|---|---|
|
Age, Customized
>=18 and <45 years
|
15 Participants
n=5 Participants
|
|
Age, Customized
>= 45 and <65 years
|
60 Participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 4, 20, 36, 52, and 53Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
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).
Outcome measures
| Measure |
Pregabalin
n=103 Participants
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.
|
|---|---|
|
Number of Participants With Peripheral Edema
Trace at Week 52/early termination (n=100)
|
10 Participants
|
|
Number of Participants With Peripheral Edema
Pitting +1 at Week 52/early termination (n=100)
|
7 Participants
|
|
Number of Participants With Peripheral Edema
Pitting +2 at Week 52/early termination (n=100)
|
2 Participants
|
|
Number of Participants With Peripheral Edema
Pitting +3 at Week 52/early termination (n=100)
|
0 Participants
|
|
Number of Participants With Peripheral Edema
Trace at Week 53/early termination (n=78)
|
9 Participants
|
|
Number of Participants With Peripheral Edema
Pitting +1 at Week 53/early termination (n=78)
|
5 Participants
|
|
Number of Participants With Peripheral Edema
Pitting +2 at Week 53/early termination (n=78)
|
0 Participants
|
|
Number of Participants With Peripheral Edema
Pitting +3 at Week 53/early termination (n=78)
|
0 Participants
|
|
Number of Participants With Peripheral Edema
Trace at Baseline (n=103)
|
5 Participants
|
|
Number of Participants With Peripheral Edema
Pitting +1 at Baseline (n=103)
|
9 Participants
|
|
Number of Participants With Peripheral Edema
Pitting +2 at Baseline (n=103)
|
2 Participants
|
|
Number of Participants With Peripheral Edema
Pitting +3 at Baseline (n=103)
|
0 Participants
|
|
Number of Participants With Peripheral Edema
Trace at Week 4 (n=101)
|
8 Participants
|
|
Number of Participants With Peripheral Edema
Pitting +1 at Week 4 (n=101)
|
8 Participants
|
|
Number of Participants With Peripheral Edema
Pitting +2 at Week 4 (n=101)
|
4 Participants
|
|
Number of Participants With Peripheral Edema
Pitting +3 at Week 4 (n=101)
|
1 Participants
|
|
Number of Participants With Peripheral Edema
Trace at Week 20 (n=93)
|
8 Participants
|
|
Number of Participants With Peripheral Edema
Pitting +1 at Week 20 (n=93)
|
3 Participants
|
|
Number of Participants With Peripheral Edema
Pitting +2 at Week 20 (n=93)
|
7 Participants
|
|
Number of Participants With Peripheral Edema
Pitting +3 at Week 20 (n=93)
|
0 Participants
|
|
Number of Participants With Peripheral Edema
Trace at Week 36 (n=90)
|
14 Participants
|
|
Number of Participants With Peripheral Edema
Pitting +1 at Week 36 (n=90)
|
7 Participants
|
|
Number of Participants With Peripheral Edema
Pitting +2 at Week 36 (n=90)
|
3 Participants
|
|
Number of Participants With Peripheral Edema
Pitting +3 at Week 36 (n=90)
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 4, 20, 36, 52, and 53Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
Number of participants who had facial or periorbital edema.
Outcome measures
| Measure |
Pregabalin
n=103 Participants
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.
|
|---|---|
|
Number of Participants With Facial/Periorbital Edema
Baseline (n=103)
|
0 Participants
|
|
Number of Participants With Facial/Periorbital Edema
Week 4 (n=101)
|
0 Participants
|
|
Number of Participants With Facial/Periorbital Edema
Week 20 (n=93)
|
0 Participants
|
|
Number of Participants With Facial/Periorbital Edema
Week 36 (n=90)
|
0 Participants
|
|
Number of Participants With Facial/Periorbital Edema
Week 52/early termination (n=100)
|
1 Participants
|
|
Number of Participants With Facial/Periorbital Edema
Week 53/early termination (n=78)
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 4, 20, 36, 52, and 53Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
Number of participants who had generalized or abdominal edema.
Outcome measures
| Measure |
Pregabalin
n=103 Participants
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.
|
|---|---|
|
Number of Participants With Generalized or Abdominal Edema
Week 20 (n=93)
|
0 Participants
|
|
Number of Participants With Generalized or Abdominal Edema
Baseline (n=103)
|
0 Participants
|
|
Number of Participants With Generalized or Abdominal Edema
Week 4 (n=101)
|
0 Participants
|
|
Number of Participants With Generalized or Abdominal Edema
Week 36 (n=90)
|
0 Participants
|
|
Number of Participants With Generalized or Abdominal Edema
Week 52/early termination (n=100)
|
1 Participants
|
|
Number of Participants With Generalized or Abdominal Edema
Week 53/early termination (n=78)
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 4, 20, 36, 52, and 53Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
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.
Outcome measures
| Measure |
Pregabalin
n=103 Participants
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.
|
|---|---|
|
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
Mild at Baseline (n=103)
|
2 Participants
|
|
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
Moderate at Baseline (n=103)
|
3 Participants
|
|
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
Severe at Baseline (n=103)
|
1 Participants
|
|
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
Mild at Week 4 (n=101)
|
5 Participants
|
|
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
Moderate at Week 4 (n=101)
|
1 Participants
|
|
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
Severe at Week 4 (n=101)
|
0 Participants
|
|
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
Mild at Week 20 (n=93)
|
3 Participants
|
|
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
Moderate at Week 20 (n=93)
|
0 Participants
|
|
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
Severe at Week 20 (n=93)
|
0 Participants
|
|
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
Mild at Week 36 (n=90)
|
3 Participants
|
|
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
Moderate at Week 36 (n=90)
|
0 Participants
|
|
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
Severe at Week 36 (n=90)
|
0 Participants
|
|
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
Mild at Week 52/early termination (n=100)
|
3 Participants
|
|
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
Moderate at Week 52/early termination (n=100)
|
0 Participants
|
|
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
Severe at Week 52/early termination (n=100)
|
1 Participants
|
|
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
Mild at Week 53/early termination (n=78)
|
2 Participants
|
|
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
Moderate at Week 53/early termination (n=78)
|
1 Participants
|
|
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
Severe at Week 53/early termination (n=78)
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 4, 20, 36, 52, and 53Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
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.
Outcome measures
| Measure |
Pregabalin
n=103 Participants
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.
|
|---|---|
|
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
Severe at Week 53/early termination (n=78)
|
0 Participants
|
|
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
Mild at Baseline (n=103)
|
0 Participants
|
|
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
Moderate at Baseline (n=103)
|
0 Participants
|
|
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
Severe at Baseline (n=103)
|
0 Participants
|
|
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
Mild at Week 4 (n=101)
|
0 Participants
|
|
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
Moderate at Week 4 (n=101)
|
0 Participants
|
|
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
Severe at Week 4 (n=101)
|
0 Participants
|
|
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
Mild at Week 20 (n=93)
|
0 Participants
|
|
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
Moderate at Week 20 (n=93)
|
0 Participants
|
|
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
Severe at Week 20 (n=93)
|
0 Participants
|
|
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
Mild at Week 36 (n=90)
|
0 Participants
|
|
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
Moderate at Week 36 (n=90)
|
0 Participants
|
|
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
Severe at Week 36 (n=90)
|
0 Participants
|
|
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
Mild at Week 52/early termination (n=100)
|
0 Participants
|
|
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
Moderate at Week 52/early termination (n=100)
|
0 Participants
|
|
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
Severe at Week 52/early termination (n=100)
|
0 Participants
|
|
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
Mild at Week 53/early termination (n=78)
|
0 Participants
|
|
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
Moderate at Week 53/early termination (n=78)
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 4, 20, 36, 52, and 53Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
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.
Outcome measures
| Measure |
Pregabalin
n=103 Participants
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.
|
|---|---|
|
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
Mild at Baseline (n=103)
|
4 Participants
|
|
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
Moderate at Baseline (n=103)
|
2 Participants
|
|
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
Severe at Baseline (n=103)
|
0 Participants
|
|
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
Mild at Week 4 (n=101)
|
3 Participants
|
|
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
Moderate at Week 4 (n=101)
|
2 Participants
|
|
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
Severe at Week 4 (n=101)
|
0 Participants
|
|
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
Mild at Week 20 (n=93)
|
3 Participants
|
|
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
Moderate at Week 20 (n=93)
|
2 Participants
|
|
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
Severe at Week 20 (n=93)
|
0 Participants
|
|
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
Mild at Week 36 (n=90)
|
4 Participants
|
|
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
Moderate at Week 36 (n=90)
|
1 Participants
|
|
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
Severe at Week 36 (n=90)
|
0 Participants
|
|
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
Mild at Week 52/early termination (n=100)
|
7 Participants
|
|
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
Moderate at Week 52/early termination (n=100)
|
0 Participants
|
|
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
Severe at Week 52/early termination (n=100)
|
0 Participants
|
|
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
Mild at Week 53/early termination (n=78)
|
5 Participants
|
|
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
Moderate at Week 53/early termination (n=78)
|
0 Participants
|
|
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
Severe at Week 53/early termination (n=78)
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 4, 20, 36, 52, and 53Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
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.
Outcome measures
| Measure |
Pregabalin
n=103 Participants
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.
|
|---|---|
|
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
Mild at Week 20 (n=93)
|
4 Participants
|
|
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
Mild at Baseline (n=103)
|
6 Participants
|
|
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
Moderate at Baseline (n=103)
|
1 Participants
|
|
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
Severe at Baseline (n=103)
|
0 Participants
|
|
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
Mild at Week 4 (n=101)
|
5 Participants
|
|
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
Moderate at Week 4 (n=101)
|
2 Participants
|
|
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
Severe at Week 4 (n=101)
|
0 Participants
|
|
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
Moderate at Week 20 (n=93)
|
1 Participants
|
|
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
Severe at Week 20 (n=93)
|
0 Participants
|
|
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
Mild at Week 36 (n=90)
|
7 Participants
|
|
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
Moderate at Week 36 (n=90)
|
0 Participants
|
|
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
Severe at Week 36 (n=90)
|
0 Participants
|
|
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
Mild at Week 52/early termination (n=100)
|
8 Participants
|
|
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
Moderate at Week 52/early termination (n=100)
|
0 Participants
|
|
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
Severe at Week 52/early termination (n=100)
|
0 Participants
|
|
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
Mild at Week 53/early termination (n=78)
|
4 Participants
|
|
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
Moderate at Week 53/early termination (n=78)
|
0 Participants
|
|
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
Severe at Week 53/early termination (n=78)
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 4, 20, 36, 52, and 53Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
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.
Outcome measures
| Measure |
Pregabalin
n=103 Participants
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.
|
|---|---|
|
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
Moderate at Baseline (n=103)
|
0 Participants
|
|
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
Severe at Baseline (n=103)
|
0 Participants
|
|
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
Mild at Week 4 (n=101)
|
0 Participants
|
|
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
Moderate at Week 4 (n=101)
|
0 Participants
|
|
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
Severe at Week 4 (n=101)
|
0 Participants
|
|
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
Mild at Week 20 (n=93)
|
0 Participants
|
|
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
Moderate at Week 20 (n=93)
|
0 Participants
|
|
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
Severe at Week 20 (n=93)
|
0 Participants
|
|
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
Mild at Week 36 (n=90)
|
0 Participants
|
|
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
Moderate at Week 36 (n=90)
|
0 Participants
|
|
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
Severe at Week 36 (n=90)
|
0 Participants
|
|
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
Mild at Week 52/early termination (n=100)
|
0 Participants
|
|
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
Moderate at Week 52/early termination (n=100)
|
0 Participants
|
|
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
Severe at Week 52/early termination (n=100)
|
0 Participants
|
|
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
Mild at Week 53/early termination (n=78)
|
0 Participants
|
|
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
Moderate at Week 53/early termination (n=78)
|
0 Participants
|
|
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
Severe at Week 53/early termination (n=78)
|
0 Participants
|
|
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
Mild at Baseline (n=103)
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 4, 20, 36, 52, and 53Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
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.
Outcome measures
| Measure |
Pregabalin
n=103 Participants
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.
|
|---|---|
|
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
Mild at Baseline (n=103)
|
0 Participants
|
|
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
Moderate at Baseline (n=103)
|
0 Participants
|
|
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
Severe at Baseline (n=103)
|
0 Participants
|
|
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
Mild at Week 4 (n=101)
|
0 Participants
|
|
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
Moderate at Week 4 (n=101)
|
0 Participants
|
|
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
Severe at Week 4 (n=101)
|
0 Participants
|
|
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
Mild at Week 20 (n=93)
|
1 Participants
|
|
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
Moderate at Week 20 (n=93)
|
0 Participants
|
|
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
Severe at Week 20 (n=93)
|
0 Participants
|
|
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
Mild at Week 36 (n=90)
|
0 Participants
|
|
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
Moderate at Week 36 (n=90)
|
0 Participants
|
|
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
Severe at Week 36 (n=90)
|
0 Participants
|
|
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
Mild at Week 52/early termination (n=100)
|
0 Participants
|
|
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
Moderate at Week 52/early termination (n=100)
|
0 Participants
|
|
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
Severe at Week 52/early termination (n=100)
|
0 Participants
|
|
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
Mild at Week 53/early termination (n=78)
|
0 Participants
|
|
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
Moderate at Week 53/early termination (n=78)
|
0 Participants
|
|
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
Severe at Week 53/early termination (n=78)
|
0 Participants
|
PRIMARY outcome
Timeframe: 53 weeksPopulation: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
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).
Outcome measures
| Measure |
Pregabalin
n=103 Participants
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.
|
|---|---|
|
Number of Participants With Visual Field Deteriorated
Right eye
|
0 Participants
|
|
Number of Participants With Visual Field Deteriorated
Left eye
|
0 Participants
|
PRIMARY outcome
Timeframe: 53 weeksPopulation: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
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.
Outcome measures
| Measure |
Pregabalin
n=103 Participants
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.
|
|---|---|
|
Number of Participants With Deterioration in Neurological Examination Findings
Cranial Nerve Function
|
0 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Mental State
|
0 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Coordination: Right (R)- Finger to Nose
|
0 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Coordination: Left (L)- Finger to Nose
|
2 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Coordination: R- Finger Tapping
|
1 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Coordination: L- Finger Tapping
|
0 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Coordination: R- Rapid Alternating Hand Movement
|
1 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Coordination: L- Rapid Alternating Hand Movement
|
2 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Coordination: Romberg Test
|
1 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Gait
|
1 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Deep Tendon Reflexes: R- Brachioradialis
|
1 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Deep Tendon Reflexes: L- Brachioradialis
|
1 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Deep Tendon Reflexes: R-Patellar
|
3 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Deep Tendon Reflexes: L-Patellar
|
3 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Deep Tendon Reflexes: R- Achilles
|
2 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Deep Tendon Reflexes: L- Achilles
|
3 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Abnormal Reflexes
|
1 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Muscle Strength: R- Upper Limb
|
1 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Muscle Strength: L- Upper Limb
|
2 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Muscle Strength: R- Lower Limb
|
1 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Muscle Strength: L- Lower Limb
|
2 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Muscle Tone: R- Upper Limb
|
1 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Muscle Tone: L- Upper Limb
|
1 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Muscle Tone: R- Lower Limb
|
5 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Muscle Tone: L- Lower Limb
|
5 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Sensory Function: Anesthesia
|
0 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Sensory Function: Hypesthesia
|
1 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Sensory Function: Allodynia
|
1 Participants
|
|
Number of Participants With Deterioration in Neurological Examination Findings
Sensory Function: Hyperalgesia
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52Population: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.
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.
Outcome measures
| Measure |
Pregabalin
n=103 Participants
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.
|
|---|---|
|
Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)
Baseline (n=103)
|
3 Participants
|
|
Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)
Week 2 (n=102)
|
2 Participants
|
|
Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)
Week 4 (n=101)
|
1 Participants
|
|
Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)
Week 8 (n=99)
|
0 Participants
|
|
Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)
Week 12 (n=96)
|
0 Participants
|
|
Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)
Week 20 (n=93)
|
2 Participants
|
|
Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)
Week 28 (n=91)
|
2 Participants
|
|
Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)
Week 36 (n=90)
|
2 Participants
|
|
Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)
Week 44 (n=85)
|
2 Participants
|
|
Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)
Week 52 (n=101)
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52Population: 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).
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.
Outcome measures
| Measure |
Pregabalin
n=103 Participants
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.
|
|---|---|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores
Week 2 (n=103)
|
-4.2 Score on a scale
Interval -5.4 to -3.0
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores
Week 4 (n=102)
|
-5.2 Score on a scale
Interval -6.4 to -4.0
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores
Week 8 (n=99)
|
-5.3 Score on a scale
Interval -6.6 to -4.0
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores
Week 12 (n=98)
|
-5.7 Score on a scale
Interval -7.3 to -4.2
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores
Week 20 (n=95)
|
-6.1 Score on a scale
Interval -7.6 to -4.7
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores
Week 28 (n=92)
|
-5.1 Score on a scale
Interval -6.6 to -3.6
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores
Week 36 (n=91)
|
-5.0 Score on a scale
Interval -6.5 to -3.5
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores
Week 44 (n=87)
|
-4.4 Score on a scale
Interval -6.1 to -2.8
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores
Week 52 (n=85)
|
-5.0 Score on a scale
Interval -6.6 to -3.4
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores
Week 52 (LOCF, n=103)
|
-4.6 Score on a scale
Interval -6.2 to -3.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52Population: 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).
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.
Outcome measures
| Measure |
Pregabalin
n=103 Participants
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.
|
|---|---|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores
Week 2 (n=103)
|
-3.1 Score on a scale
Interval -4.1 to -2.2
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores
Week 4 (n=102)
|
-3.9 Score on a scale
Interval -4.8 to -3.0
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores
Week 8 (n=99)
|
-3.9 Score on a scale
Interval -4.9 to -3.0
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores
Week 12 (n=98)
|
-4.2 Score on a scale
Interval -5.4 to -3.1
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores
Week 20 (n=95)
|
-4.5 Score on a scale
Interval -5.6 to -3.4
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores
Week 28 (n=92)
|
-3.8 Score on a scale
Interval -5.0 to -2.7
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores
Week 36 (n=91)
|
-3.7 Score on a scale
Interval -4.8 to -2.6
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores
Week 44 (n=87)
|
-3.1 Score on a scale
Interval -4.4 to -1.9
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores
Week 52 (n=85)
|
-3.6 Score on a scale
Interval -4.8 to -2.4
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores
Week 52 (LOCF, n=103)
|
-3.6 Score on a scale
Interval -4.8 to -2.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52Population: 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).
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.
Outcome measures
| Measure |
Pregabalin
n=103 Participants
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.
|
|---|---|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores
Week 2 (n=103)
|
-1.1 Score on a scale
Interval -1.5 to -0.5
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores
Week 4 (n=102)
|
-1.3 Score on a scale
Interval -1.7 to -0.8
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores
Week 8 (n=99)
|
-1.3 Score on a scale
Interval -1.8 to -0.9
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores
Week 12 (n=98)
|
-1.5 Score on a scale
Interval -2.0 to -1.0
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores
Week 20 (n=95)
|
-1.6 Score on a scale
Interval -2.1 to -1.2
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores
Week 28 (n=92)
|
-1.3 Score on a scale
Interval -1.8 to -0.9
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores
Week 36 (n=91)
|
-1.3 Score on a scale
Interval -1.8 to -0.7
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores
Week 44 (n=87)
|
-1.3 Score on a scale
Interval -1.9 to -0.7
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores
Week 52 (n=85)
|
-1.4 Score on a scale
Interval -1.9 to -0.9
|
|
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores
Week 52 (LOCF, n=103)
|
-1.0 Score on a scale
Interval -1.5 to -0.5
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: 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).
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.
Outcome measures
| Measure |
Pregabalin
n=103 Participants
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.
|
|---|---|
|
Change From Baseline in the Modified Brief Pain Inventory (10 Item) (mBPI-10)Total Scores at Last Evaluation Score
|
-1.4 Score on a scale
Interval -1.9 to -0.9
|
Adverse Events
Pregabalin
Serious events: 19 serious events
Other events: 91 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregabalin
n=103 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.97%
1/103 • 53 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
Anal fistula
|
0.97%
1/103 • 53 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
Colonic polyp
|
0.97%
1/103 • 53 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
Inguinal hernia
|
0.97%
1/103 • 53 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
Melaena
|
0.97%
1/103 • 53 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
Tooth development disorder
|
0.97%
1/103 • 53 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.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.97%
1/103 • 53 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
Cellulitis
|
1.9%
2/103 • 53 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
Infected skin ulcer
|
0.97%
1/103 • 53 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
|
0.97%
1/103 • 53 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
Sepsis
|
0.97%
1/103 • 53 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
Urinary tract infection
|
0.97%
1/103 • 53 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
Femur fracture
|
0.97%
1/103 • 53 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
Mucosal excoriation
|
0.97%
1/103 • 53 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
Cerebral haemorrhage
|
0.97%
1/103 • 53 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
Cerebral infarction
|
1.9%
2/103 • 53 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
Transient ischaemic attack
|
0.97%
1/103 • 53 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
Psychotic disorder
|
0.97%
1/103 • 53 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
Nasal polyps
|
0.97%
1/103 • 53 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.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.97%
1/103 • 53 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=103 participants at risk
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.
|
|---|---|
|
Eye disorders
Visual acuity reduced
|
6.8%
7/103 • 53 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
|
7.8%
8/103 • 53 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
Feeling abnormal
|
6.8%
7/103 • 53 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%
18/103 • 53 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
Thirst
|
6.8%
7/103 • 53 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
|
25.2%
26/103 • 53 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
Contusion
|
7.8%
8/103 • 53 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
|
12.6%
13/103 • 53 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
|
30.1%
31/103 • 53 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
Back pain
|
7.8%
8/103 • 53 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
|
23.3%
24/103 • 53 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
Hypoaesthesia
|
5.8%
6/103 • 53 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
|
51.5%
53/103 • 53 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.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.8%
7/103 • 53 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.8%
8/103 • 53 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
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