Trial Outcomes & Findings for PF-06372865 In Subjects With Chronic Low Back Pain (NCT NCT02262754)

Last Updated: 2017-01-04

Results Overview

Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain. Baseline value was calculated as the mean of the scores over the last 7 days in the placebo run-in period, prior to randomization. Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

302 participants

Primary outcome timeframe

Baseline, Week 4

Results posted on

2017-01-04

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Overall Study STARTED	74	74	74
Overall Study COMPLETED	58	65	65
Overall Study NOT COMPLETED	16	9	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Overall Study Adverse Event	3	4	0
Overall Study Lack of Efficacy	2	0	1
Overall Study Lost to Follow-up	0	0	1
Overall Study No longer meets eligibility criteria	0	1	0
Overall Study Study terminated by sponsor	5	4	4
Overall Study Protocol Violation	1	0	0
Overall Study Withdrawal by Subject	1	0	1
Overall Study Other	4	0	2

Baseline Characteristics

PF-06372865 In Subjects With Chronic Low Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.	Total n=222 Participants Total of all reporting groups
Age, Continuous	51.1 years STANDARD_DEVIATION 12.1 • n=5 Participants	49.7 years STANDARD_DEVIATION 13.8 • n=7 Participants	51.6 years STANDARD_DEVIATION 13.1 • n=5 Participants	50.8 years STANDARD_DEVIATION 12.9 • n=4 Participants
Gender FEMALE	38 Participants n=5 Participants	39 Participants n=7 Participants	37 Participants n=5 Participants	114 Participants n=4 Participants
Gender MALE	36 Participants n=5 Participants	35 Participants n=7 Participants	37 Participants n=5 Participants	108 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: FAS included all participants randomized and who had received at least 1 dose of randomized treatment.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Change From Baseline in Daily Low Back Pain Intensity (LBPI) Score as Measured by an 11-point Numeric Rating Scale (NRS) at Week 4	-1.19 units on a scale 90% Confidence Interval 1.351 • Interval -1.5 to -0.89	-1.03 units on a scale 90% Confidence Interval 1.091 • Interval -1.35 to -0.71	-1.45 units on a scale 90% Confidence Interval 1.401 • Interval -1.77 to -1.14

PRIMARY outcome

Timeframe: Baseline up to 28 days after the last dose of study treatment (Day 56)

Population: Safety analysis set included all participants who received at least 1 dose of study treatment.

An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. The SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	26 participants 1.351 • Interval -1.5 to -0.89	34 participants 1.091 • Interval -1.35 to -0.71	28 participants 1.401 • Interval -1.77 to -1.14
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	1 participants	1 participants	2 participants

PRIMARY outcome

Timeframe: Baseline up to 28 days after the last dose of study treatment (Day 56)

Population: Safety analysis set included all participants who received at least 1 dose of study treatment. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Abnormality criteria included: hemoglobin, hematocrit and red blood cells (RBCs) (less than \[\<\] 0.8\*lower limit of normal \[LLN\]); white blood cells (WBC) (\<0.6\*LLN, greater than \[\>\] 1.5\*upper limit of normal \[ULN\]); MCV, MCH, MCHC (\<0.9\*LLN, \>1.1\*ULN); platelets (\<0.5\*LLN\>, \>1.75\*ULN); neutrophils, lymphocytes(\<0.8\*LLN, \>1.2\*ULN); eosinophils, basophils, monocytes (\>1.2\*ULN); total bilirubin (\>1.5\*ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (\>3\*ULN); total protein, albumin (\<0.8\*LLN, \>1.2\*ULN); creatinine, blood urea nitrogen (\>1.3\*ULN); glucose (\<0.6\*LLN, \>1.5\*ULN); uric acid (\>1.2\*ULN); sodium, potassium, chloride, calcium, bicarbonate (\<0.9\*LLN, \>1.1\*ULN); urine pH (\<4.5, \>8); qualitative urine glucose, ketones, protein, blood values (greater than or equal to \[\>=\] 1) in urine dipstick test; urine RBC, WBC (\>=20); hyaline casts (\>1), bacteria (\>20).

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Number of Participants With Laboratory Abnormalities	26 participants	44 participants	41 participants

PRIMARY outcome

Timeframe: Baseline up to Follow-up (44 days)

Population: Safety analysis set included all participants who received at least 1 dose of study treatment.

Participants who met the criteria for abnormal findings in vital signs data were reported. Criteria for abnormalities in vital signs: supine systolic blood pressure (SBP) \<90 millimeter of mercury (mmHg), supine diastolic BP (DBP) \<50 mmHg, supine pulse rate \<40 beats per minute (bpm) or \>120 bpm. Maximum increase or decrease from baseline in supine SBP \>=30 mmHg and maximum increase or decrease from baseline in supine DBP \>=20 mmHg.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Number of Participants With Vital Sign Abnormalities Supine SBP: <90 mmHg	0 participants 1.351 • Interval -1.5 to -0.89	1 participants 1.091 • Interval -1.35 to -0.71	0 participants 1.401 • Interval -1.77 to -1.14
Number of Participants With Vital Sign Abnormalities Supine DBP: <50 mmHg	0 participants	1 participants	0 participants
Number of Participants With Vital Sign Abnormalities Supine pulse rate: <40 bpm	0 participants	0 participants	0 participants
Number of Participants With Vital Sign Abnormalities Supine pulse rate: >120 bpm	0 participants	0 participants	0 participants
Number of Participants With Vital Sign Abnormalities Maximum increase in Supine SBP: >=30 mmHg	5 participants	0 participants	1 participants
Number of Participants With Vital Sign Abnormalities Maximum increase in Supine DBP: >=20 mmHg	6 participants	3 participants	4 participants
Number of Participants With Vital Sign Abnormalities Maximum decrease in Supine SBP: >=30 mmHg	1 participants	6 participants	4 participants
Number of Participants With Vital Sign Abnormalities Maximum decrease in Supine DBP: >=20 mmHg	3 participants	9 participants	3 participants

PRIMARY outcome

Timeframe: Baseline up to Follow-up (44 days)

Population: Safety analysis set included all participants who received at least 1 dose of study treatment. Here, "n" signifies the number of participants evaluable for the specific category.

Participants with abnormal ECG findings were reported. Criteria for potential clinical concern in ECG parameters: maximum (max.) PR interval of \>=300 milliseconds (msec), maximum QRS interval \>=140 msec, maximum QTCF interval (Fridericia's Correction) of 450 to \<480 msec, 480 to \<500 msec and \>=500 msec, maximum of \>=25 percent (%) increase from baseline (IFB) value of \>200 msec and \>=50% for baseline value of less than or equal to (\<=) 200 msec for PR interval, maximum increase from baseline of \>=50% for QRS interval, maximum increase from baseline of \>=30 msec to \<60 msec and maximum increase from baseline of \>60 msec in QTCF interval (Fridericia's Correction).

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Number of Participants With Electrocardiogram (ECG) Abnormalities Max. PR Interval: >=300 msec (n=72, 74, 72)	0 participants 1.351 • Interval -1.5 to -0.89	0 participants 1.091 • Interval -1.35 to -0.71	0 participants 1.401 • Interval -1.77 to -1.14
Number of Participants With Electrocardiogram (ECG) Abnormalities Max. QRS Complex: >=140 msec (n=72, 74, 72)	0 participants	0 participants	1 participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Max. QTCF Interval: 450 to <480 msec (n=72,74,72)	1 participants	1 participants	2 participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Max. QTCF Interval: 480 to <500 msec (n=72,74,72)	0 participants	1 participants	0 participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Max. QTCF Interval: >=500 msec (n=72, 74, 72)	0 participants	0 participants	0 participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Max. PR Interval IFB: >=25 or 50% (n=72, 74, 71)	1 participants	0 participants	0 participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Max. QRS Complex IFB: >=50% (n=72, 74, 72)	1 participants	0 participants	1 participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Max. QTCF Interval IFB: 30 to<60 msec (n=72,74,72)	3 participants	4 participants	0 participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Max. QTCF Interval IFB: >=60 msec (n=72,74,72)	3 participants	1 participants	0 participants

PRIMARY outcome

Timeframe: Screening, Baseline, Week 1, 2, 3, 4

Population: Data was not collected for this outcome measure as per study team's decision, since it was a semi-structured interview and was difficult to pull accurate scores from it.

The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment \[C-CASA\]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide =1, suicide attempt =2 (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior =3 ("Yes" on "preparatory acts or behavior"), suicidal ideation =4 ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior =7 ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: End of treatment (Day 30), follow-up (Day 44)

Population: Safety analysis set included all participants who received at least 1 dose of study treatment.

PWC is a 20 item physician rated interview to measure anxiolytic drug withdrawal-related signs and symptoms. Each individual item score ranges from 0 (not present) to 3 (severe), where higher scores = more affected condition. PWC total score range from 0 (not present) to 60 (severe), where higher score = more affected condition. Change: score at follow-up visit minus score at the end of treatment visit.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Change From End of Treatment Visit in Physician's Withdrawal Checklist (PWC) Score at Follow-up Visit	-0.11 units on a scale 90% Confidence Interval 1.351 • Interval -0.49 to 0.28	-0.34 units on a scale 90% Confidence Interval 1.091 • Interval -0.71 to 0.03	0.01 units on a scale 90% Confidence Interval 1.401 • Interval -0.36 to 0.38

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4

Population: FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, "n" signifies participants who were evaluable at the specified time point for each arm.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2 3 and 4 Change at week 1 (n= 74, 74, 74)	-0.50 units on a scale 90% Confidence Interval 1.351 • Interval -0.69 to -0.3	-0.41 units on a scale 90% Confidence Interval 1.091 • Interval -0.61 to -0.22	-0.70 units on a scale 90% Confidence Interval 1.401 • Interval -0.9 to -0.5
Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2 3 and 4 Change at week 2 (n= 65, 70, 72)	-0.93 units on a scale Interval -1.21 to -0.65	-0.98 units on a scale Interval -1.25 to -0.7	-1.17 units on a scale Interval -1.44 to -0.9
Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2 3 and 4 Change at week 3 (n= 62, 69, 70)	-1.12 units on a scale Interval -1.43 to -0.82	-1.09 units on a scale Interval -1.39 to -0.8	-1.39 units on a scale Interval -1.68 to -1.1
Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2 3 and 4 Change at week 4 (n= 59, 64, 66)	-1.22 units on a scale Interval -1.56 to -0.87	-1.14 units on a scale Interval -1.48 to -0.81	-1.58 units on a scale Interval -1.91 to -1.25

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Percent Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2, 3 and 4 Change at week 1 (n= 74, 74, 74)	-7.453 percent change Standard Deviation 18.2639 • Interval 0.87 to 0.94	-5.830 percent change Standard Deviation 16.0979 • Interval 0.89 to 0.97	-10.601 percent change Standard Deviation 17.4139 • Interval 0.84 to 0.91
Percent Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2, 3 and 4 Change at week 2 (n= 65, 70, 72)	-15.190 percent change Standard Deviation 21.7655 • Interval 0.76 to 0.87	-15.467 percent change Standard Deviation 20.4505 • Interval 0.77 to 0.88	-17.682 percent change Standard Deviation 24.3704 • Interval 0.73 to 0.83
Percent Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2, 3 and 4 Change at week 3 (n= 62, 69, 70)	-19.100 percent change Standard Deviation 25.5461	-17.167 percent change Standard Deviation 23.7288	-22.204 percent change Standard Deviation 23.2540
Percent Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2, 3 and 4 Change at week 4 (n= 59, 64, 66)	-20.958 percent change Standard Deviation 25.5848	-17.072 percent change Standard Deviation 27.4016	-23.906 percent change Standard Deviation 28.0190

SECONDARY outcome

Timeframe: Baseline up to Week 4

Population: FAS included all participants randomized and who had received at least 1 dose of randomized treatment.

Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10. Percentage of reduction from baseline in the daily average LBPI NRS score was calculated as: (\[daily value - baseline value\] divided by baseline value) multiplied by 100. Number of participants with sustained response rates (for a minimum of 4 consecutive days) in the daily average LBPI NRS scores that were at \>=30 percent and \>=50 percent reduced from baseline were reported.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Number of Participants With Sustained Response Rates in Daily Average LBPI NRS Scores at Greater Than or Equal to (>=) 30 Percent and >=50 Percent Reduction From Baseline >=30 percent response	25 participants 1.351 • Interval -1.5 to -0.89	24 participants 1.091 • Interval -1.35 to -0.71	31 participants 1.401 • Interval -1.77 to -1.14
Number of Participants With Sustained Response Rates in Daily Average LBPI NRS Scores at Greater Than or Equal to (>=) 30 Percent and >=50 Percent Reduction From Baseline >=50 percent response	11 participants	9 participants	12 participants

SECONDARY outcome

Timeframe: Baseline up to Week 4

Population: FAS included all participants randomized and who had received at least 1 dose of randomized treatment.

Participants withdrew from the study due to lack of efficacy (insufficient clinical response) were reported.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Number of Participants Withdrawn Due to Lack of Efficacy	2 participants 1.351 • Interval -1.5 to -0.89	0 participants 1.091 • Interval -1.35 to -0.71	1 participants 1.401 • Interval -1.77 to -1.14

SECONDARY outcome

Timeframe: Baseline up to Week 4

Population: FAS included all participants randomized and who had received at least 1 dose of randomized treatment.

Kaplan Meier and Cox Proportional Hazards analyses were to be used to compute the time to withdrawal due to lack of efficacy. Withdrawal due to lack of efficacy was identified from the participant summary case report form (CRF) page and where reason was identified as "Insufficient Clinical Response". Time to withdrawal was calculated as Date of withdrawal - Date of Randomization.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Time to Withdrawal Due to Lack of Efficacy	NA days 90% Confidence Interval 1.351 Outcome was to be assessed as time to event analysis by Kaplan-Meier estimates. However, median and 90% CI were not estimable since very few participants withdrew from study due to lack of efficacy: 2 in placebo group, 1 in naproxen group.	NA days 90% Confidence Interval 1.091 Outcome was to be assessed as time to event analysis by Kaplan-Meier estimates. However, median and 90% CI were not estimable since very few participants withdrew from study due to lack of efficacy: 2 in placebo group, 1 in naproxen group.	NA days 90% Confidence Interval 1.401 Outcome was to be assessed as time to event analysis by Kaplan-Meier estimates. However, median and 90% CI were not estimable since very few participants withdrew from study due to lack of efficacy: 2 in placebo group, 1 in naproxen group.

SECONDARY outcome

Timeframe: Week 1, 2, 3, 4

Participants were permitted to use any commercial product (tablet/caplet/capsule) of acetaminophen (paracetamol) 500 mg as a rescue medication. Number of participants who used rescue medication were reported.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Number of Participants Using Rescue Medication Week 1 (n= 74, 74, 74)	34 participants 1.351 • Interval -1.5 to -0.89	35 participants 1.091 • Interval -1.35 to -0.71	34 participants 1.401 • Interval -1.77 to -1.14
Number of Participants Using Rescue Medication Week 2 (n= 67, 72, 72)	26 participants	32 participants	30 participants
Number of Participants Using Rescue Medication Week 3 (n= 63, 69, 71)	25 participants	31 participants	27 participants
Number of Participants Using Rescue Medication Week 4 (59, 66, 67)	23 participants	27 participants	22 participants

SECONDARY outcome

Timeframe: Week 1, 2, 3, 4

The number of days for which the participants used the rescue medication were reported. Participants recorded the usage of acetaminophen rescue medication in the daily diary.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Number of Days Participants Used the Rescue Medication Week 2 (n= 67, 72, 72)	1.6 days Standard Deviation 2.65	1.8 days Standard Deviation 2.77	1.6 days Standard Deviation 2.54
Number of Days Participants Used the Rescue Medication Week 3 (n= 63, 69, 71)	1.9 days Standard Deviation 3.11	1.4 days Standard Deviation 2.22	1.5 days Standard Deviation 2.46
Number of Days Participants Used the Rescue Medication Week 4 (59, 66, 67)	1.4 days Standard Deviation 2.37	1.4 days Standard Deviation 2.15	1.4 days Standard Deviation 2.45
Number of Days Participants Used the Rescue Medication Week 1 (n= 74, 74, 74)	1.7 days Standard Deviation 2.62 • Interval -1.5 to -0.89	1.7 days Standard Deviation 2.49 • Interval -1.35 to -0.71	1.7 days Standard Deviation 2.44 • Interval -1.77 to -1.14

SECONDARY outcome

Timeframe: Week 1, 2, 3, 4

The amount of rescue medication (Acetaminophen \[paracetamol\]) used was reported. Participants were permitted to use any commercial product of acetaminophen tablet/caplet/capsule.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Amount of Rescue Medication Used by the Participants Week 1 (n= 72, 70, 74)	1388.9 mg Standard Deviation 2703.97 • Interval -1.5 to -0.89	1621.8 mg Standard Deviation 4169.38 • Interval -1.35 to -0.71	2064.5 mg Standard Deviation 4298.80 • Interval -1.77 to -1.14
Amount of Rescue Medication Used by the Participants Week 2 (n= 65, 68, 72)	1030.8 mg Standard Deviation 1669.76	1594.1 mg Standard Deviation 3708.11	1920.5 mg Standard Deviation 4327.48
Amount of Rescue Medication Used by the Participants Week 3 (n= 61, 65, 71)	1172.1 mg Standard Deviation 1955.52	1416.9 mg Standard Deviation 3552.05	1740.5 mg Standard Deviation 4361.26
Amount of Rescue Medication Used by the Participants Week 4 (n= 58, 62, 67)	1101.7 mg Standard Deviation 2069.03	1348.8 mg Standard Deviation 2925.65	1489.2 mg Standard Deviation 3567.20

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3

Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1, 2, and 3 Baseline (n= 74, 74, 74)	9.8 units on a scale Standard Deviation 5.47	9.4 units on a scale Standard Deviation 5.23	8.5 units on a scale Standard Deviation 5.48
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1, 2, and 3 Change at week 1 (n= 73, 73, 73)	-0.4 units on a scale Standard Deviation 2.48	-0.5 units on a scale Standard Deviation 3.73	-1.2 units on a scale Standard Deviation 3.51
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1, 2, and 3 Change at week 2 (n= 66, 71, 72)	-0.7 units on a scale Standard Deviation 3.17	-1.3 units on a scale Standard Deviation 3.59	-1.6 units on a scale Standard Deviation 4.07
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1, 2, and 3 Change at week 3 (n= 62, 67, 71)	-1.0 units on a scale Standard Deviation 3.24	-1.3 units on a scale Standard Deviation 3.39	-2.0 units on a scale Standard Deviation 4.21

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: FAS included all participants randomized and who had received at least 1 dose of randomized treatment.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4	-1.00 units on a scale 90% Confidence Interval 3.36 • Interval -1.67 to -0.33	-1.64 units on a scale 90% Confidence Interval 3.85 • Interval -2.35 to -0.92	-2.43 units on a scale 90% Confidence Interval 4.73 • Interval -3.14 to -1.71

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4

This test assesses verbal learning and memory. Participants are given a list of 12 words and asked to repeat as many words as they can recall during 3 separate learning trials. The total recall score ranges from 0 (no memory) to 36 (best memory) while the delayed recall trial score ranges from 0 (no memory) to 12 (best memory); higher scores indicated greater verbal learning and recall.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4 Total recall score: at Baseline (n= 74,74,74)	24.47 units on a scale Standard Deviation 5.118	22.92 units on a scale Standard Deviation 5.581	24.46 units on a scale Standard Deviation 5.455
Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4 Total recall score: Change at Week 2 (n= 66,72,71)	0.74 units on a scale Standard Deviation 3.702 • Interval -0.28 to 0.62	0.57 units on a scale Standard Deviation 3.950 • Interval -1.03 to -0.17	-0.30 units on a scale Standard Deviation 4.773 • Interval -0.44 to 0.43
Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4 Total recall score: Change at Week 4 (n= 56,66,66)	1.43 units on a scale Standard Deviation 3.637 • Interval -0.03 to 1.62	0.68 units on a scale Standard Deviation 3.522	0.11 units on a scale Standard Deviation 4.062
Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4 Delayed Recall Score: at Baseline (n= 74,74,74)	8.59 units on a scale Standard Deviation 2.415	8.31 units on a scale Standard Deviation 2.828	8.59 units on a scale Standard Deviation 2.643
Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4 Delayed Recall Score:Change at Week 2 (n=66,72,71)	0.18 units on a scale Standard Deviation 2.225	-0.57 units on a scale Standard Deviation 2.803	-0.06 units on a scale Standard Deviation 1.912
Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4 Delayed Recall Score:Change at Week 4 (n=56,65,66)	0.57 units on a scale Standard Deviation 1.925	-0.28 units on a scale Standard Deviation 2.197	0.41 units on a scale Standard Deviation 1.831

SECONDARY outcome

Timeframe: Week 1, 2, 3, 4

Population: FAS included all participants randomized and who had received at least 1 dose of randomized treatment.

Participants were successful responders if they had any of the following: \>=30 percent reduction in mean daily average LBPI from baseline to particular week; decrease of \>=30 percent in participant's global assessment of low back pain (disease activity) from baseline to particular week or no worsening (increase) in RMDQ total score from baseline to particular week.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Chronic Low Back Pain (CLBP) Responder Index Analysis Week 1	0 participants 2.62 • Interval -1.5 to -0.89	0 participants 2.49 • Interval -1.35 to -0.71	8 participants 2.44 • Interval -1.77 to -1.14
Chronic Low Back Pain (CLBP) Responder Index Analysis Week 2	5 participants 2.65	8 participants 2.77	11 participants 2.54
Chronic Low Back Pain (CLBP) Responder Index Analysis Week 3	12 participants 3.11	8 participants 2.22	14 participants 2.46
Chronic Low Back Pain (CLBP) Responder Index Analysis Week 4	9 participants 2.37	11 participants 2.15	19 participants 2.45

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4

Participant rated 5-point Likert scale ranging from 0 (no pain) to 4 (worst possible pain) with a higher score indicating greater level of pain.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Change From Baseline in Participant's Global Assessment (PtGA) of Low Back Pain Score at Week 1, 2, 3 and 4 Change at Week 1 (n= 73, 73, 73)	-0.20 units on a scale Interval -0.33 to -0.06	-0.19 units on a scale Interval -0.33 to -0.05	-0.34 units on a scale Interval -0.48 to -0.2
Change From Baseline in Participant's Global Assessment (PtGA) of Low Back Pain Score at Week 1, 2, 3 and 4 Change at Week 2 (n= 66, 71, 72)	-0.24 units on a scale Interval -0.4 to -0.09	-0.28 units on a scale Interval -0.43 to -0.13	-0.39 units on a scale Interval -0.55 to -0.24
Change From Baseline in Participant's Global Assessment (PtGA) of Low Back Pain Score at Week 1, 2, 3 and 4 Change at Week 3 (n= 62, 67, 71)	-0.45 units on a scale Interval -0.62 to -0.29	-0.31 units on a scale Interval -0.47 to -0.14	-0.43 units on a scale Interval -0.6 to -0.27
Change From Baseline in Participant's Global Assessment (PtGA) of Low Back Pain Score at Week 1, 2, 3 and 4 Change at Week 4 (n= 58, 65, 65)	-0.33 units on a scale Interval -0.52 to -0.15	-0.21 units on a scale Interval -0.38 to -0.03	-0.54 units on a scale Interval -0.71 to -0.36

SECONDARY outcome

Timeframe: Week 1, 2, 3, 4

PGI-C was a participant rated instrument to measure participant's assessment of change in his or her overall status since the previous visit on a 7-point scale; ranging from 1 (very much improved) to 7 (very much worse), where higher scores indicated more worsening.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Patient Global Impression of Change (PGI-C) Score Week 1 (n= 73, 73, 73)	3.32 units on a scale Interval 3.14 to 3.49	3.15 units on a scale Interval 2.97 to 3.32	2.95 units on a scale Interval 2.77 to 3.12
Patient Global Impression of Change (PGI-C) Score Week 2 (n= 66, 71, 72)	3.12 units on a scale Interval 2.91 to 3.33	3.04 units on a scale Interval 2.83 to 3.24	2.83 units on a scale Interval 2.63 to 3.04
Patient Global Impression of Change (PGI-C) Score Week 3 (n= 62, 67, 71)	3.01 units on a scale Interval 2.81 to 3.22	2.94 units on a scale Interval 2.74 to 3.14	2.63 units on a scale Interval 2.43 to 2.83
Patient Global Impression of Change (PGI-C) Score Week 4 (n= 58, 65, 65)	3.04 units on a scale Interval 2.81 to 3.27	2.93 units on a scale Interval 2.72 to 3.15	2.61 units on a scale Interval 2.39 to 2.82

SECONDARY outcome

Timeframe: Week 4

Population: FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Participants rated their study treatment by GESM questionnaire. It was a qualitative measure of efficacy utilizing a 4-point Likert scale ranging from 1 (poor) to 4 (excellent), where higher score indicated a better overall response to the treatment. Number of participants who reported a particular score had been reported.

Outcome measures

Outcome measures
Measure	Placebo n=70 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=73 Participants Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=71 Participants Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Number of Participants With Global Evaluation of Study Medication (GESM) at Week 4 Good	28 participants 3.11	36 participants 2.22	37 participants 2.46
Number of Participants With Global Evaluation of Study Medication (GESM) at Week 4 Poor	8 participants 2.62 • Interval -1.5 to -0.89	11 participants 2.49 • Interval -1.35 to -0.71	5 participants 2.44 • Interval -1.77 to -1.14
Number of Participants With Global Evaluation of Study Medication (GESM) at Week 4 Fair	26 participants 2.65	18 participants 2.77	14 participants 2.54
Number of Participants With Global Evaluation of Study Medication (GESM) at Week 4 Excellent	8 participants 2.37	8 participants 2.15	15 participants 2.45

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4

Data was calculated by setting concentration values below the lower limit of quantification (LLOQ) to zero. The LLOQ was \<0.0100 nanogram per milliliter (ng/mL).

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Plasma Concentration of PF-06372865 Baseline (n= 73)	NA ng/mL Standard Deviation NA Data was not collected at baseline since number of observations above lower limit of quantification (NALQ) = 0.	—	—
Plasma Concentration of PF-06372865 Week 1 (n= 74)	15.57 ng/mL Standard Deviation 13.214	—	—
Plasma Concentration of PF-06372865 Week 2 (n= 72)	47.51 ng/mL Standard Deviation 45.668	—	—
Plasma Concentration of PF-06372865 Week 3 (n= 71)	46.65 ng/mL Standard Deviation 46.305	—	—
Plasma Concentration of PF-06372865 Week 4 (n= 65)	48.24 ng/mL Standard Deviation 41.975	—	—

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4

Data was calculated by setting concentration values below the LLOQ to zero. The LLOQ was \<1000 ng/mL.

Outcome measures

Outcome measures
Measure	Placebo n=74 Participants Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Plasma Concentration of Naproxen Baseline (n= 73)	317.0 ng/mL Standard Deviation 1963.4	—	—
Plasma Concentration of Naproxen Week 1 (n= 74)	68150 ng/mL Standard Deviation 35213	—	—
Plasma Concentration of Naproxen Week 2 (n= 72)	67830 ng/mL Standard Deviation 37004	—	—
Plasma Concentration of Naproxen Week 3 (n= 71)	67140 ng/mL Standard Deviation 38336	—	—
Plasma Concentration of Naproxen Week 4 (n= 65)	65650 ng/mL Standard Deviation 33419	—	—

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

PF-06372865

Serious events: 1 serious events

Other events: 34 other events

Deaths: 0 deaths

Naproxen

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=74 participants at risk Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	PF-06372865 n=74 participants at risk Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Naproxen n=74 participants at risk Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Cardiac disorders Angina pectoris	1.4% 1/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Ileus paralytic	0.00% 0/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.4% 1/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	0.00% 0/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.4% 1/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fall	0.00% 0/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.4% 1/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Syncope	1.4% 1/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Transient ischaemic attack	0.00% 0/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.4% 1/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.4% 1/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypotension	1.4% 1/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/74 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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Restriction type: OTHER