A Clinical Trial To Evaluate PF-05089771 On Its Own And A... | NCT02215252

NCT02215252

ID	Type	Description	Link
DPN NAV1.7	Other Identifier	Alias Study Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
PF-05089771	Experimental	Drug: PF-05089771 150 mg
Placebo	Experimental	Drug: Matched placebo for PF-05089771 150 mg and pregabalin 300 mg
Pregabalin	Experimental	Drug: Pregabalin 300 mg
PF-05089771 + Pregabalin	Experimental	Drug: PF-05089771 150 mg + Pregabalin 300 mg

Name	Type	Description	Arm Group Labels	Other Names
PF-05089771 150 mg	Drug	PF-05089771 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.	PF-05089771

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Daily Pain Numeric Rating Scale (NRS)	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.	Baseline, Week 1, Week 2, Week 3 and Week 4

Secondary Outcomes

Measure	Description	Time Frame
Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score	Percentage of participants that received ≥30% improvement from baseline in mean pain response (from the daily pain diary).	Baseline, Week 1, Week 2, Week 3 and Week 4
Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Consortium Arizona		Phoenix	Arizona	85003	United States
Arizona Research Center

References Module

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	PF-05089771 150 mg BID	Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
FG001	Pregabalin	Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

The safety analysis set consisted of all participants who received at least one dose of study medication.

Arm/Group Information

ID	Title	Description
BG000	PF-05089771 150 mg BID	Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
BG001	Pregabalin	Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
BG002	Placebo	Participants received matched placebo oral capsule for 4 weeks.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Baseline (n = 44, 46, 45)

Title	Measurements
	OG0006.17± 1.164 OG0016.62± 1.420 OG0026.35± 1.170

Week 1 (n = 44, 46, 44)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Statistical analysis is only for week 4. Mixed Models Repeated Measures analysis including all data up to Week 4 ,incorporating Bayesian priors separately on the placebo response and pregabalin effect.					Mean Difference (Final Values)	-0.41	Standard Deviation	0.355	2-Sided	90	-1.00	0.17					Superiority or Other
OG001

Secondary

Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score

Percentage of participants that received ≥30% improvement from baseline in mean pain response (from the daily pain diary).

The full analysis set included all randomized participants who received at least one dose of study medication.

Posted

Number

Percentage of participants

Baseline, Week 1, Week 2, Week 3 and Week 4

ID	Title	Description
OG000	PF-05089771 150 mg BID	Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
OG001	Pregabalin	Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
OG002	Placebo	Participants received matched placebo oral capsule for 4 weeks.

Units	Counts
Participants

Secondary

Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score

Percentage of participants that received ≥50% improvement from baseline in mean pain response (from the daily pain diary).

The full analysis set included all randomized participants who received at least one dose of study medication.

Posted

Number

Percentage of participants

Baseline, Week 1, Week 2, Week 3, and Week 4

ID	Title	Description
OG000	PF-05089771 150 mg BID	Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
OG001	Pregabalin	Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
OG002	Placebo	Participants received matched placebo oral capsule for 4 weeks.

Units	Counts
Participants

Secondary

Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain

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.

The full analysis set included all randomized participants who received at least one dose of study medication.

Posted

Mean

Standard Deviation

Unit on a scale

Baseline, Week 2, and Week 4

ID	Title	Description
OG000	PF-05089771 150 mg BID	Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
OG001	Pregabalin	Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
OG002	Placebo	Participants received matched placebo oral capsule for 4 weeks.

Secondary

Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain

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.

The full analysis set included all randomized participants who received at least one dose of study medication.

Posted

Mean

Standard Deviation

Unit on a scale

Baseline, Week 2 and Week 4

ID	Title	Description
OG000	PF-05089771 150 mg BID	Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
OG001	Pregabalin	Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
OG002	Placebo	Participants received matched placebo oral capsule for 4 weeks.

Secondary

Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain

The full analysis set included all randomized participants who received at least one dose of study medication.

Posted

Mean

Standard Deviation

Unit on a scale

Baseline, Week 2, and Week 4

ID	Title	Description
OG000	PF-05089771 150 mg BID	Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
OG001	Pregabalin	Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
OG002	Placebo	Participants received matched placebo oral capsule for 4 weeks.

Secondary

Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain

The full analysis set included all randomized participants who received at least one dose of study medication.

Posted

Mean

Standard Deviation

Unit on a scale

Baseline, Week 2 and Week 4

ID	Title	Description
OG000	PF-05089771 150 mg BID	Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
OG001	Pregabalin	Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
OG002	Placebo	Participants received matched placebo oral capsule for 4 weeks.

Secondary

Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia

The full analysis set included all randomized participants who received at least one dose of study medication.

Posted

Mean

Standard Deviation

Unit on a scale

Baseline, Week 2 and Week 4

ID	Title	Description
OG000	PF-05089771 150 mg BID	Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
OG001	Pregabalin	Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
OG002	Placebo	Participants received matched placebo oral capsule for 4 weeks.

Secondary

Neuropathic Pain Symptom Inventory (NPSI) - Total Score

The full analysis set included all randomized participants who received at least one dose of study medication.

Posted

Mean

Standard Deviation

Unit on a scale

Baseline, Week 2 and Week 4

ID	Title	Description
OG000	PF-05089771 150 mg BID	Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
OG001	Pregabalin	Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
OG002	Placebo	Participants received matched placebo oral capsule for 4 weeks.

Secondary

Patient's Global Impression of Change Score (PGIC).

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".

The full analysis set included all randomized participants who received at least one dose of study medication.

Posted

Number

Number of participants

Baseline, Week 2, and Week 4

ID	Title	Description
OG000	PF-05089771 150 mg BID	Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
OG001	Pregabalin	Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
OG002	Placebo	Participants received matched placebo oral capsule for 4 weeks.

Units	Counts
Participants

Secondary

Daily Sleep Interference Scale Score (DSIS).

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.

The full analysis set included all randomized participants who received at least one dose of study medication.

Posted

Mean

Standard Deviation

number on a scale

Baseline, Week 1, Week 2, Week 3 and Week 4

ID	Title	Description
OG000	PF-05089771 150 mg BID	Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
OG001	Pregabalin	Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
OG002	Placebo	Participants received matched placebo oral capsule for 4 weeks.

Units

Secondary

Total Amount of Rescue Medication Per Week

Total amount of rescue medication participants take per week

The full analysis set included all randomized participants who received at least one dose of study medication.

Posted

Mean

Standard Deviation

Baseline, Week 1, Week 2, Week 3, and Week 4

ID	Title	Description
OG000	PF-05089771 150 mg BID	Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
OG001	Pregabalin	Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
OG002	Placebo	Participants received matched placebo oral capsule for 4 weeks.

Units	Counts
Participants	OG000

Secondary

Number of Days Participants Take Rescue Medication

Number of days participants take rescue medication per week.

The full analysis set included all randomized participants who received at least one dose of study medication.

Posted

Mean

Standard Deviation

days

Baseline, Week 1, Week 2, Week 3 and Week 4

ID	Title	Description
OG000	PF-05089771 150 mg BID	Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
OG001	Pregabalin	Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
OG002	Placebo	Participants received matched placebo oral capsule for 4 weeks.

Units	Counts
Participants

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs)

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.

The safety analysis set included all participants who receive at least 1 dose of study medication.

Posted

Number

Participants

Screening to Day 36, and Day 64

ID	Title	Description
OG000	PF-05089771 150 mg BID	Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
OG001	Pregabalin	Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
OG002	Placebo	Participants received matched placebo oral capsule for 4 weeks.

Secondary

Number of Participants With Laboratory Test Values of Potential Clinical Importance

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.

The safety analysis set included all participants who receive at least 1 dose of study medication.

Posted

Number

Participants

Screening, Day 1, Day 15 and Day 29

ID	Title	Description
OG000	PF-05089771 150 mg BID	Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
OG001	Pregabalin	Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
OG002	Placebo	Participants received matched placebo oral capsule for 4 weeks.

Units	Counts
Participants

Secondary

Fasted Total Cholesterol Values

Percentage Change from Baseline in Fasted Total Cholesterol values

The safety analysis set included all participants who receive at least 1 dose of study medication.

Posted

Mean

Standard Deviation

Percent change

Baseline, Week 2 and Week 4

ID	Title	Description
OG000	PF-05089771 150 mg BID	Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
OG001	Pregabalin	Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
OG002	Placebo	Participants received matched placebo oral capsule for 4 weeks.

Units	Counts
Participants	OG000

Secondary

Fasted Low Density Lipoprotein (LDL) Cholesterol

Percentage Change from Baseline in LDL cholesterol Friedewald by PEG

The safety analysis set included all participants who receive at least 1 dose of study medication.

Posted

Mean

Standard Deviation

Perecent change

Baseline, Week 2 and Week 4

ID	Title	Description
OG000	PF-05089771 150 mg BID	Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
OG001	Pregabalin	Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
OG002	Placebo	Participants received matched placebo oral capsule for 4 weeks.

Units	Counts
Participants	OG000

Secondary

Plasma Concentration of PF-05089771

All participants in this group were analysed. Only plasma PK concentration of PF-05089771 was analysed.

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.

Posted

Mean

Standard Deviation

ng/ml

Baseline, Week 2 and Week 4

ID	Title	Description
OG000	PF-05089771 150 mg BID	Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.

Units	Counts
Participants	OG00044

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PF-05089771 150 mg BID	Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.	1	44	3	44
EG001	Pregabalin	Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.	1	46	12	46
EG002	Placebo	Participants received matched placebo oral capsule for 4 weeks.	0	45	10	45

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure congestive	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected44 at risk EG0011 affected46 at risk EG0020 affected45 at risk
Pneumonia	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected44 at risk EG0010 affected46 at risk EG0020 affected45 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected44 at risk EG0010 affected46 at risk EG0020 affected45 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected44 at risk EG0013 affected46 at risk EG0021 affected45 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected44 at risk EG0011 affected46 at risk EG0023 affected45 at risk
Dizziness	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected44 at risk EG0015 affected46 at risk EG0022 affected45 at risk
Headache	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment		EG0002 affected44 at risk EG0013 affected46 at risk EG0024 affected45 at risk
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA 18.1	Non-systematic Assessment	AE specific to female participants. Hence the number of participants at risk refers to number of female participants.	EG0000 affected17 at risk EG0011 affected19 at risk EG0020 affected14 at risk

ID	Term
D003929	Diabetic Neuropathies

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D048909	Diabetes Complications
D003920	Diabetes Mellitus
D004700	Endocrine System Diseases

ID	Term
C000618268	PF-05089771
D000069583	Pregabalin

Ancestor Terms

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins

OG00044
OG00146
OG00245

OG00044
OG00146
OG00245

Units	Counts
Participants	OG00044 OG00146 OG00245