Trial Outcomes & Findings for A Clinical Trial To Evaluate PF-05089771 On Its Own And As An Add-On Therapy To Pregabalin (Lyrica) For The Treatment Of Pain Due To Diabetic Peripheral Neuropathy (DPN) (NCT NCT02215252)
NCT ID: NCT02215252
Last Updated: 2017-05-05
Results Overview
The endpoint average pain score, based on the mean of the last 7 days' daily pain numeric rating scale (NRS) scores at (NRS is an 11-point scale where 0 = no pain and 10 = worst possible pain) from the daily pain diaries while receiving study medication during the treatment period.
COMPLETED
PHASE2
141 participants
Baseline, Week 1, Week 2, Week 3 and Week 4
2017-05-05
Participant Flow
Eligibility included healthy male and/or female participants of non childbearing potential between the ages of 18 and 80 years, inclusive, and a diagnosis of painful diabetic peripheral neuropathy and type II diabetes. Following the interim analysis, the study was stopped. No participants were dosed with PF-05089771 150mg BID + pregabalin.
A number of 141 participants were the anticipated to be enrolled based on a discontinuation rate calculated from previous Pfizer DPN studies. The study discontinuation rate was lower than anticipated, hence fewer participants were randomized.
Participant milestones
| Measure |
PF-05089771 150 mg BID
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
44
|
46
|
45
|
|
Overall Study
COMPLETED
|
42
|
38
|
41
|
|
Overall Study
NOT COMPLETED
|
2
|
8
|
4
|
Reasons for withdrawal
| Measure |
PF-05089771 150 mg BID
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
5
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Does not Meet Entrance Criteria
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Other
|
0
|
1
|
1
|
Baseline Characteristics
A Clinical Trial To Evaluate PF-05089771 On Its Own And As An Add-On Therapy To Pregabalin (Lyrica) For The Treatment Of Pain Due To Diabetic Peripheral Neuropathy (DPN)
Baseline characteristics by cohort
| Measure |
PF-05089771 150 mg BID
n=44 Participants
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
n=46 Participants
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
n=45 Participants
Participants received matched placebo oral capsule for 4 weeks.
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
59.2 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
58.9 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3 and Week 4Population: The full analysis set included all randomized participants who received at least one dose of study medication.
The endpoint average pain score, based on the mean of the last 7 days' daily pain numeric rating scale (NRS) scores at (NRS is an 11-point scale where 0 = no pain and 10 = worst possible pain) from the daily pain diaries while receiving study medication during the treatment period.
Outcome measures
| Measure |
PF-05089771 150 mg BID
n=44 Participants
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
n=46 Participants
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
n=45 Participants
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Daily Pain Numeric Rating Scale (NRS)
Baseline (n = 44, 46, 45)
|
6.17 Unit on a scale
Standard Deviation 1.164
|
6.62 Unit on a scale
Standard Deviation 1.420
|
6.35 Unit on a scale
Standard Deviation 1.170
|
|
Daily Pain Numeric Rating Scale (NRS)
Week 1 (n = 44, 46, 44)
|
5.45 Unit on a scale
Standard Deviation 1.372
|
5.87 Unit on a scale
Standard Deviation 1.872
|
6.07 Unit on a scale
Standard Deviation 1.454
|
|
Daily Pain Numeric Rating Scale (NRS)
Week 3 (n = 38, 40, 41)
|
5.01 Unit on a scale
Standard Deviation 1.820
|
5.36 Unit on a scale
Standard Deviation 2.386
|
5.76 Unit on a scale
Standard Deviation 1.540
|
|
Daily Pain Numeric Rating Scale (NRS)
Week 4 (n = 41, 38, 39)
|
4.83 Unit on a scale
Standard Deviation 1.595
|
5.14 Unit on a scale
Standard Deviation 2.508
|
5.61 Unit on a scale
Standard Deviation 1.820
|
|
Daily Pain Numeric Rating Scale (NRS)
Week 2 (n = 43, 44, 40)
|
5.14 Unit on a scale
Standard Deviation 1.762
|
5.26 Unit on a scale
Standard Deviation 2.302
|
6.10 Unit on a scale
Standard Deviation 1.504
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3 and Week 4Population: The full analysis set included all randomized participants who received at least one dose of study medication.
Percentage of participants that received ≥30% improvement from baseline in mean pain response (from the daily pain diary).
Outcome measures
| Measure |
PF-05089771 150 mg BID
n=44 Participants
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
n=46 Participants
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
n=45 Participants
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score
Week 1 (n = 44, 46, 45)
|
9.09 Percentage of participants
|
15.22 Percentage of participants
|
4.44 Percentage of participants
|
|
Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score
Week 2 (n = 44, 45, 44)
|
22.73 Percentage of participants
|
31.11 Percentage of participants
|
9.09 Percentage of participants
|
|
Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score
Week 3 (n = 42, 42, 43)
|
23.81 Percentage of participants
|
26.19 Percentage of participants
|
11.63 Percentage of participants
|
|
Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score
Week 4 (n = 42, 38, 43)
|
28.57 Percentage of participants
|
31.58 Percentage of participants
|
16.28 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, and Week 4Population: The full analysis set included all randomized participants who received at least one dose of study medication.
Percentage of participants that received ≥50% improvement from baseline in mean pain response (from the daily pain diary).
Outcome measures
| Measure |
PF-05089771 150 mg BID
n=44 Participants
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
n=46 Participants
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
n=45 Participants
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score
Week 4 (n = 42, 38, 43)
|
9.52 Percentage of participants
|
23.68 Percentage of participants
|
6.98 Percentage of participants
|
|
Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score
Week 1 (n = 44, 46, 45)
|
0 Percentage of participants
|
4.35 Percentage of participants
|
4.44 Percentage of participants
|
|
Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score
Week 2 (n = 44, 45, 44)
|
11.36 Percentage of participants
|
15.56 Percentage of participants
|
2.27 Percentage of participants
|
|
Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score
Week 3 (n = 42, 42, 43)
|
7.14 Percentage of participants
|
19.05 Percentage of participants
|
2.33 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, and Week 4Population: The full analysis set included all randomized participants who received at least one dose of study medication.
Participants rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Outcome measures
| Measure |
PF-05089771 150 mg BID
n=44 Participants
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
n=46 Participants
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
n=45 Participants
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain
Baseline (n = 44, 46, 45)
|
4.6 Unit on a scale
Standard Deviation 2.71
|
5.3 Unit on a scale
Standard Deviation 2.49
|
4.8 Unit on a scale
Standard Deviation 2.35
|
|
Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain
Week 2 (n = 42, 41, 43)
|
3.7 Unit on a scale
Standard Deviation 2.94
|
4.3 Unit on a scale
Standard Deviation 3.06
|
4.2 Unit on a scale
Standard Deviation 2.35
|
|
Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain
Week 4 (n = 42, 38, 42)
|
3.4 Unit on a scale
Standard Deviation 3.04
|
4.3 Unit on a scale
Standard Deviation 2.80
|
4.5 Unit on a scale
Standard Deviation 2.55
|
SECONDARY outcome
Timeframe: Baseline, Week 2 and Week 4Population: The full analysis set included all randomized participants who received at least one dose of study medication.
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Outcome measures
| Measure |
PF-05089771 150 mg BID
n=44 Participants
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
n=46 Participants
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
n=45 Participants
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain
Baseline (n = 44, 46, 45)
|
3.8 Unit on a scale
Standard Deviation 2.48
|
4.9 Unit on a scale
Standard Deviation 2.21
|
4.5 Unit on a scale
Standard Deviation 2.40
|
|
Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain
Week 2 (n = 42, 41, 43)
|
3.3 Unit on a scale
Standard Deviation 2.51
|
4.4 Unit on a scale
Standard Deviation 2.83
|
4.2 Unit on a scale
Standard Deviation 2.33
|
|
Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain
Week 4 (n = 42, 38, 42)
|
3.4 Unit on a scale
Standard Deviation 2.67
|
3.9 Unit on a scale
Standard Deviation 3.08
|
4.0 Unit on a scale
Standard Deviation 2.48
|
SECONDARY outcome
Timeframe: Baseline, Week 2, and Week 4Population: The full analysis set included all randomized participants who received at least one dose of study medication.
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Outcome measures
| Measure |
PF-05089771 150 mg BID
n=44 Participants
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
n=46 Participants
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
n=45 Participants
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain
Baseline (n = 44, 46, 45)
|
4.5 Unit on a scale
Standard Deviation 2.36
|
5.8 Unit on a scale
Standard Deviation 2.18
|
5.6 Unit on a scale
Standard Deviation 2.23
|
|
Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain
Week 2 (n = 42, 41, 43)
|
4.1 Unit on a scale
Standard Deviation 2.61
|
4.7 Unit on a scale
Standard Deviation 2.98
|
4.9 Unit on a scale
Standard Deviation 2.11
|
|
Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain
Week 4 (n = 42, 38, 42）
|
3.9 Unit on a scale
Standard Deviation 2.87
|
4.6 Unit on a scale
Standard Deviation 2.83
|
4.8 Unit on a scale
Standard Deviation 2.55
|
SECONDARY outcome
Timeframe: Baseline, Week 2 and Week 4Population: The full analysis set included all randomized participants who received at least one dose of study medication.
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Outcome measures
| Measure |
PF-05089771 150 mg BID
n=44 Participants
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
n=46 Participants
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
n=45 Participants
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain
Baseline (n = 44, 45, 45)
|
2.7 Unit on a scale
Standard Deviation 2.38
|
5.0 Unit on a scale
Standard Deviation 2.51
|
4.2 Unit on a scale
Standard Deviation 2.42
|
|
Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain
Week 2 (n = 42, 40, 43)
|
2.0 Unit on a scale
Standard Deviation 1.92
|
4.0 Unit on a scale
Standard Deviation 2.67
|
3.5 Unit on a scale
Standard Deviation 2.47
|
|
Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain
Week 4 (n = 42, 37, 42)
|
2.3 Unit on a scale
Standard Deviation 2.24
|
3.8 Unit on a scale
Standard Deviation 3.07
|
3.6 Unit on a scale
Standard Deviation 2.53
|
SECONDARY outcome
Timeframe: Baseline, Week 2 and Week 4Population: The full analysis set included all randomized participants who received at least one dose of study medication.
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Outcome measures
| Measure |
PF-05089771 150 mg BID
n=44 Participants
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
n=46 Participants
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
n=45 Participants
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia
Baseline (n = 44, 46, 45)
|
5.7 Unit on a scale
Standard Deviation 2.02
|
6.1 Unit on a scale
Standard Deviation 2.35
|
6.6 Unit on a scale
Standard Deviation 1.96
|
|
Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia
Week 2 (n = 42, 41, 43)
|
4.8 Unit on a scale
Standard Deviation 2.45
|
5.3 Unit on a scale
Standard Deviation 2.83
|
5.9 Unit on a scale
Standard Deviation 2.40
|
|
Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia
Week 4 (n = 42, 38, 42)
|
4.9 Unit on a scale
Standard Deviation 2.34
|
5.4 Unit on a scale
Standard Deviation 2.84
|
5.9 Unit on a scale
Standard Deviation 2.63
|
SECONDARY outcome
Timeframe: Baseline, Week 2 and Week 4Population: The full analysis set included all randomized participants who received at least one dose of study medication.
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Outcome measures
| Measure |
PF-05089771 150 mg BID
n=44 Participants
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
n=46 Participants
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
n=45 Participants
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Neuropathic Pain Symptom Inventory (NPSI) - Total Score
Baseline (n = 44, 45, 45）
|
40.6 Unit on a scale
Standard Deviation 17.33
|
53.4 Unit on a scale
Standard Deviation 19.35
|
50.7 Unit on a scale
Standard Deviation 16.87
|
|
Neuropathic Pain Symptom Inventory (NPSI) - Total Score
Week 2 (n = 42, 40, 34)
|
34.2 Unit on a scale
Standard Deviation 17.39
|
44.6 Unit on a scale
Standard Deviation 24.64
|
44.7 Unit on a scale
Standard Deviation 18.11
|
|
Neuropathic Pain Symptom Inventory (NPSI) - Total Score
Week 4 (n = 42, 37, 42)
|
34.7 Unit on a scale
Standard Deviation 19.40
|
42.7 Unit on a scale
Standard Deviation 27.23
|
44.5 Unit on a scale
Standard Deviation 20.18
|
SECONDARY outcome
Timeframe: Baseline, Week 2, and Week 4Population: The full analysis set included all randomized participants who received at least one dose of study medication.
Participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse) at week 4. The PGIC was combined to produce a 3-point scale, "Improved", "No Change" and "Worse".
Outcome measures
| Measure |
PF-05089771 150 mg BID
n=44 Participants
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
n=46 Participants
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
n=45 Participants
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Patient's Global Impression of Change Score (PGIC).
Improved (Week 2, n = 42, 41, 43)
|
27 Number of participants
|
30 Number of participants
|
26 Number of participants
|
|
Patient's Global Impression of Change Score (PGIC).
Improved (Week 4, n = 42, 38, 42)
|
28 Number of participants
|
27 Number of participants
|
24 Number of participants
|
|
Patient's Global Impression of Change Score (PGIC).
Improved (Baseline, n = 43, 46, 45)
|
20 Number of participants
|
11 Number of participants
|
16 Number of participants
|
|
Patient's Global Impression of Change Score (PGIC).
Worse (Baseline, n = 43, 46, 35)
|
4 Number of participants
|
5 Number of participants
|
4 Number of participants
|
|
Patient's Global Impression of Change Score (PGIC).
Worse (Week 2, n = 42, 41, 43)
|
5 Number of participants
|
4 Number of participants
|
4 Number of participants
|
|
Patient's Global Impression of Change Score (PGIC).
Worse (Week 4, n = 42, 38, 42)
|
2 Number of participants
|
2 Number of participants
|
4 Number of participants
|
|
Patient's Global Impression of Change Score (PGIC).
No change (Baseline, n = 43, 46, 45)
|
19 Number of participants
|
30 Number of participants
|
25 Number of participants
|
|
Patient's Global Impression of Change Score (PGIC).
No change (Week 2, n = 42, 41, 43)
|
10 Number of participants
|
7 Number of participants
|
13 Number of participants
|
|
Patient's Global Impression of Change Score (PGIC).
No change (Week 4, n = 42, 38, 42)
|
12 Number of participants
|
9 Number of participants
|
14 Number of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3 and Week 4Population: The full analysis set included all randomized participants who received at least one dose of study medication.
Participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. This score was measured as a weekly average.
Outcome measures
| Measure |
PF-05089771 150 mg BID
n=44 Participants
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
n=46 Participants
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
n=45 Participants
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Daily Sleep Interference Scale Score (DSIS).
Baseline (n = 44, 46, 45)
|
4.7 number on a scale
Standard Deviation 2.42
|
5.6 number on a scale
Standard Deviation 2.38
|
4.9 number on a scale
Standard Deviation 2.29
|
|
Daily Sleep Interference Scale Score (DSIS).
Week 1 (n= 44, 46, 44)
|
4.1 number on a scale
Standard Deviation 2.29
|
4.7 number on a scale
Standard Deviation 2.55
|
4.7 number on a scale
Standard Deviation 2.46
|
|
Daily Sleep Interference Scale Score (DSIS).
Week 2 (n = 43, 44, 40)
|
4.0 number on a scale
Standard Deviation 2.33
|
4.1 number on a scale
Standard Deviation 2.74
|
4.7 number on a scale
Standard Deviation 2.41
|
|
Daily Sleep Interference Scale Score (DSIS).
Week 3 (n = 38, 40, 41)
|
3.6 number on a scale
Standard Deviation 2.28
|
4.4 number on a scale
Standard Deviation 2.71
|
4.3 number on a scale
Standard Deviation 2.49
|
|
Daily Sleep Interference Scale Score (DSIS).
Week 4 (n = 41, 38, 39)
|
3.4 number on a scale
Standard Deviation 2.13
|
4.2 number on a scale
Standard Deviation 2.82
|
4.3 number on a scale
Standard Deviation 2.51
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, and Week 4Population: The full analysis set included all randomized participants who received at least one dose of study medication.
Total amount of rescue medication participants take per week
Outcome measures
| Measure |
PF-05089771 150 mg BID
n=44 Participants
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
n=46 Participants
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
n=45 Participants
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Total Amount of Rescue Medication Per Week
Week 2 (n = 44, 45, 44)
|
1669 mg
Standard Deviation 3248
|
2952 mg
Standard Deviation 5488
|
1391 mg
Standard Deviation 3238
|
|
Total Amount of Rescue Medication Per Week
Week 3 (n = 42, 42, 43)
|
1851 mg
Standard Deviation 3228
|
1885 mg
Standard Deviation 4918
|
1306 mg
Standard Deviation 3308
|
|
Total Amount of Rescue Medication Per Week
Week 4 (n = 42, 38, 43)
|
1617 mg
Standard Deviation 2945
|
2328 mg
Standard Deviation 5256
|
1372 mg
Standard Deviation 3307
|
|
Total Amount of Rescue Medication Per Week
Baseline (n = 44, 46, 45)
|
2726 mg
Standard Deviation 4310
|
3398 mg
Standard Deviation 5723
|
1863 mg
Standard Deviation 3684
|
|
Total Amount of Rescue Medication Per Week
Week 1 (n = 44, 46, 45)
|
2272 mg
Standard Deviation 4043
|
2897 mg
Standard Deviation 5605
|
1694 mg
Standard Deviation 3425
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3 and Week 4Population: The full analysis set included all randomized participants who received at least one dose of study medication.
Number of days participants take rescue medication per week.
Outcome measures
| Measure |
PF-05089771 150 mg BID
n=44 Participants
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
n=46 Participants
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
n=45 Participants
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Number of Days Participants Take Rescue Medication
Week 2 (n = 44, 45, 44)
|
2.0 days
Standard Deviation 3.08
|
1.7 days
Standard Deviation 2.63
|
1.2 days
Standard Deviation 2.25
|
|
Number of Days Participants Take Rescue Medication
Week 3 (n = 42, 42, 43)
|
2.1 days
Standard Deviation 3.00
|
1.2 days
Standard Deviation 2.35
|
1.0 days
Standard Deviation 2.10
|
|
Number of Days Participants Take Rescue Medication
Week 4 (n = 42, 38, 43)
|
1.9 days
Standard Deviation 2.80
|
1.6 days
Standard Deviation 2.55
|
1.1 days
Standard Deviation 2.28
|
|
Number of Days Participants Take Rescue Medication
Baseline (n = 44, 46, 45)
|
2.8 days
Standard Deviation 3.49
|
2.1 days
Standard Deviation 3.02
|
1.6 days
Standard Deviation 2.60
|
|
Number of Days Participants Take Rescue Medication
Week 1 (n = 44, 46, 45)
|
2.3 days
Standard Deviation 3.16
|
1.8 days
Standard Deviation 2.74
|
1.5 days
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: Screening to Day 36, and Day 64Population: The safety analysis set included all participants who receive at least 1 dose of study medication.
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect.
Outcome measures
| Measure |
PF-05089771 150 mg BID
n=44 Participants
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
n=46 Participants
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
n=45 Participants
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs)
Participants with TEAEs
|
16 Participants
|
24 Participants
|
17 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs)
Participants with SAE
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs)
Withdrawals due to AEs
|
1 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Screening, Day 1, Day 15 and Day 29Population: The safety analysis set included all participants who receive at least 1 dose of study medication.
The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis and some other tests.
Outcome measures
| Measure |
PF-05089771 150 mg BID
n=44 Participants
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
n=46 Participants
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
n=45 Participants
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Number of Participants With Laboratory Test Values of Potential Clinical Importance
|
38 Participants
|
35 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2 and Week 4Population: The safety analysis set included all participants who receive at least 1 dose of study medication.
Percentage Change from Baseline in Fasted Total Cholesterol values
Outcome measures
| Measure |
PF-05089771 150 mg BID
n=44 Participants
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
n=46 Participants
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
n=45 Participants
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Fasted Total Cholesterol Values
Week 2 (n = 41, 37, 41)
|
3.46 Percent change
Standard Deviation 12.279
|
-1.45 Percent change
Standard Deviation 10.242
|
-0.43 Percent change
Standard Deviation 14.271
|
|
Fasted Total Cholesterol Values
Week 4 (n = 40, 33, 39)
|
6.59 Percent change
Standard Deviation 15.618
|
-0.11 Percent change
Standard Deviation 10.023
|
-1.71 Percent change
Standard Deviation 14.242
|
SECONDARY outcome
Timeframe: Baseline, Week 2 and Week 4Population: The safety analysis set included all participants who receive at least 1 dose of study medication.
Percentage Change from Baseline in LDL cholesterol Friedewald by PEG
Outcome measures
| Measure |
PF-05089771 150 mg BID
n=44 Participants
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
n=46 Participants
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
n=45 Participants
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Fasted Low Density Lipoprotein (LDL) Cholesterol
Week 2 (n = 38, 34, 39)
|
8.17 Perecent change
Standard Deviation 23.849
|
-1.73 Perecent change
Standard Deviation 14.496
|
0.81 Perecent change
Standard Deviation 22.900
|
|
Fasted Low Density Lipoprotein (LDL) Cholesterol
Week 4 (n = 37, 31, 36)
|
13.61 Perecent change
Standard Deviation 29.729
|
0.85 Perecent change
Standard Deviation 13.512
|
1.48 Perecent change
Standard Deviation 19.804
|
SECONDARY outcome
Timeframe: Baseline, Week 2 and Week 4Population: The PK concentration analysis set included all randomized participants who received at least one dose of study medication and who had at least 1 measurable concentration.
All participants in this group were analysed. Only plasma PK concentration of PF-05089771 was analysed.
Outcome measures
| Measure |
PF-05089771 150 mg BID
n=44 Participants
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Plasma Concentration of PF-05089771
Week 2 (n = 41)
|
7673 ng/ml
Standard Deviation 4861
|
—
|
—
|
|
Plasma Concentration of PF-05089771
Baseline (n = 43)
|
NA ng/ml
Standard Deviation NA
No Mean/SD at baseline. No subject had PK concentration value above lower limit of quantification at baseline in both groups. Summary statistics are not presented.
|
—
|
—
|
|
Plasma Concentration of PF-05089771
Week 4 (n = 41)
|
8784 ng/ml
Standard Deviation 5749
|
—
|
—
|
Adverse Events
PF-05089771 150 mg BID
Pregabalin
Placebo
Serious adverse events
| Measure |
PF-05089771 150 mg BID
n=44 participants at risk
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
n=46 participants at risk
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
n=45 participants at risk
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/44 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
2.2%
1/46 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
0.00%
0/45 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
|
Infections and infestations
Pneumonia
|
2.3%
1/44 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
0.00%
0/46 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
0.00%
0/45 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.3%
1/44 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
0.00%
0/46 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
0.00%
0/45 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
Other adverse events
| Measure |
PF-05089771 150 mg BID
n=44 participants at risk
Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
|
Pregabalin
n=46 participants at risk
Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
|
Placebo
n=45 participants at risk
Participants received matched placebo oral capsule for 4 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/44 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
6.5%
3/46 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
2.2%
1/45 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
1/44 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
2.2%
1/46 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
6.7%
3/45 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/44 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
10.9%
5/46 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
4.4%
2/45 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
|
Nervous system disorders
Headache
|
4.5%
2/44 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
6.5%
3/46 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
8.9%
4/45 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/17 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
5.3%
1/19 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
0.00%
0/14 • From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.
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 1 participant and as non-serious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
|
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