Phase 2 N=222 Randomized Double-blind Treatment

PF-06372865 In Subjects With Chronic Low Back Pain

Chronic Low Back Pain

Bottom Line

View on ClinicalTrials.gov: NCT02262754 ↗

Enrolled (actual)

222

Serious AEs

1.8%

Results posted

Jan 2017

Primary outcome: Primary: 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; -1.03; -1.45 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: PF-06372865 (Drug); Placebo (Drug); Naproxen (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY 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; -1.03; -1.45	—
PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	26; 34; 28; 1; 1; 2	—
PRIMARY Number of Participants With Laboratory Abnormalities	26; 44; 41	—
PRIMARY Number of Participants With Vital Sign Abnormalities	0; 1; 0; 0; 1; 0	—
PRIMARY Number of Participants With Electrocardiogram (ECG) Abnormalities	0; 0; 0; 0; 0; 1	—
PRIMARY Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)	—	—
PRIMARY Change From End of Treatment Visit in Physician's Withdrawal Checklist (PWC) Score at Follow-up Visit	-0.11; -0.34; 0.01	—
SECONDARY 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	-0.50; -0.41; -0.70; -0.93; -0.98; -1.17	—
SECONDARY 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	-7.453; -5.830; -10.601; -15.190; -15.467; -17.682	—
SECONDARY 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	25; 24; 31; 11; 9; 12	—
SECONDARY Number of Participants Withdrawn Due to Lack of Efficacy	2; 0; 1	—
SECONDARY Time to Withdrawal Due to Lack of Efficacy	NA; NA; NA	—
SECONDARY Number of Participants Using Rescue Medication	34; 35; 34; 26; 32; 30	—
SECONDARY Number of Days Participants Used the Rescue Medication	1.7; 1.7; 1.7; 1.6; 1.8; 1.6	—
SECONDARY Amount of Rescue Medication Used by the Participants	1388.9; 1621.8; 2064.5; 1030.8; 1594.1; 1920.5	—
SECONDARY Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1, 2, and 3	9.8; 9.4; 8.5; -0.4; -0.5; -1.2	—
SECONDARY Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4	-1.00; -1.64; -2.43	—
SECONDARY Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4	24.47; 22.92; 24.46; 0.74; 0.57; -0.30	—
SECONDARY Chronic Low Back Pain (CLBP) Responder Index Analysis	0; 0; 8; 5; 8; 11	—
SECONDARY Change From Baseline in Participant's Global Assessment (PtGA) of Low Back Pain Score at Week 1, 2, 3 and 4	-0.20; -0.19; -0.34; -0.24; -0.28; -0.39	—
SECONDARY Patient Global Impression of Change (PGI-C) Score	3.32; 3.15; 2.95; 3.12; 3.04; 2.83	—
SECONDARY Number of Participants With Global Evaluation of Study Medication (GESM) at Week 4	8; 11; 5; 26; 18; 14	—
SECONDARY Plasma Concentration of PF-06372865	NA; 15.57; 47.51; 46.65; 48.24	—
SECONDARY Plasma Concentration of Naproxen	317.0; 68150; 67830; 67140; 65650	—

Summary

PF-06372865 In Subjects With Chronic Low Back Pain

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02262754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.