PF-06372865 In Subjects With Chronic Low Back Pain

NCT02262754 | Completed Phase 2 Results

• 1 other identifier: B7431006
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 46

Brief Summary

PF-06372865 In Subjects With Chronic Low Back Pain

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (7)

• Change From Baseline in Daily Low Back Pain Intensity (LBPI) Score as Measured by an 11-point Numeric Rating Scale (NRS) at Week 4

  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.

  Baseline, Week 4

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  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.

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

• Number of Participants With Laboratory Abnormalities

  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).

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

• Number of Participants With Vital Sign Abnormalities

  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.

  Baseline up to Follow-up (44 days)

• Number of Participants With Electrocardiogram (ECG) Abnormalities

  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).

  Baseline up to Follow-up (44 days)

• Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

  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").

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

• Change From End of Treatment Visit in Physician's Withdrawal Checklist (PWC) Score at Follow-up Visit

  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.

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

Secondary Outcomes (17)

• 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

  Baseline, Week 1, 2, 3, 4

• 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

  Baseline, Week 1, 2, 3, 4

• 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

  Baseline up to Week 4

• Number of Participants Withdrawn Due to Lack of Efficacy

  Baseline up to Week 4

• Time to Withdrawal Due to Lack of Efficacy

  Baseline up to Week 4

Study Arms (3)

PF-06372865

EXPERIMENTAL

Daily BID dosing for 4 weeks

Drug: PF-06372865

Placebo

PLACEBO COMPARATOR

Daily BID dosing for 4 weeks

Drug: Placebo

Naproxen

ACTIVE COMPARATOR

Daily BID dosing for 4 weeks

Drug: Naproxen

Interventions

PF-06372865 DRUG

Dose level 1 daily dosing BID for 1 week followed by dose level 2 daily BID for 3 weeks

PF-06372865

Placebo DRUG

Placebo for PF-06372865 and placebo for naproxen daily

Placebo

Naproxen DRUG

500 mg BID for 4 weeks

Naproxen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (46)

Agave Clinical Research, LLC

Mesa, Arizona, 85202, United States

Location

Arizona Research Center, Inc.

Phoenix, Arizona, 85023, United States

Location

Global Research

Anaheim, California, 92804, United States

Location

Neuro-Pain Medical Center

Fresno, California, 93710, United States

Location

Providence Clinical Research

North Hollywood, California, 91606, United States

Location

Elite Clinical Trials, Incorporate

Wildomar, California, 92595, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

S&W Clinical Research

Fort Lauderdale, Florida, 33306, United States

Location

Florida Research Network, LLC

Gainesville, Florida, 32605, United States

Location

Broward Research Group

Hollywood, Florida, 33024, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Pines Clinical Research Inc.

Pembroke Pines, Florida, 33028, United States

Location

Accord Clinical Research, LLC

Port Orange, Florida, 32129, United States

Location

Arthritis & Rheumatic Care Center

South Miami, Florida, 33143, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Better Health Clinical Research, Inc.

Atlanta, Georgia, 30344, United States

Location

River Birch Research Alliance, LLC

Blue Ridge, Georgia, 30513, United States

Location

Family Medicine center

Columbus, Georgia, 31901, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

Better Health Clinical Research, Inc./Georgia Pain & Spine Care, Inc.

Newnan, Georgia, 30265, United States

Location

Better Health Clinical Research, Inc.

Newnan, Georgia, 30265, United States

Location

Southeast Regional Research Group

Savannah, Georgia, 31405, United States

Location

North Georgia Clinical Research

Woodstock, Georgia, 30189, United States

Location

North Georgia Internal medicine

Woodstock, Georgia, 30189, United States

Location

Chicago Anesthesia Associates

Chicago, Illinois, 60657, United States

Location

Centex Studies, Inc

Lake Charles, Louisiana, 70601, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

ActivMed Practices & Research, Inc.

Methuen, Massachusetts, 01844, United States

Location

CRC of Jackson

Jackson, Mississippi, 39202, United States

Location

Physician's Surgery Center

Jackson, Mississippi, 39202, United States

Location

Drug Trials America

Hartsdale, New York, 10530, United States

Location

AAIR Research Center

Rochester, New York, 14618, United States

Location

Wake Internal Medicine Consultants, Inc.

Raleigh, North Carolina, 27612, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Summit Research Network (Oregon), Inc.

Portland, Oregon, 97210, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Lee Medical Associates, PA

San Antonio, Texas, 78229, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78229, United States

Location

National Clinical Research - Norfolk, Inc.

Norfolk, Virginia, 23502, United States

Location

Summit Research Network (Seattle) LLC

Seattle, Washington, 98104, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

PF-06372865; Naproxen

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1--800--718--1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 13, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 4, 2017
• Results First Posted: January 4, 2017

Record last verified: 2016-11

Locations

US (46)