PF-06372865 In Subjects With Chronic Low Back Pain

Study at a glance

From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Randomized, Double Blind, Placebo- And Active-controlled, 4 Week, Multi-center, Parallel Group Study Assessing The Analgesic Effect, Safety And Tolerability Of Pf-06372865 In Subjects With Chronic Low Back Pain Using Naproxen As Positive Control

ClinicalTrials.gov ID

NCT02262754

Acronym / sponsor ID

B7431006

Conditions

Chronic Low Back Pain

Phase

Phase 2

Study type

Interventional

Recruitment status

Completed

Enrolment

302 participants (actual)

Lead sponsor

PfizerIndustry (pharma, biotech, devices)

Study start

Oct 2014

Primary completion

Aug 2015 (actual)

Study completion

Aug 2015 (actual)

First posted

13 Oct 2014 (estimated)

Results

Posted 4 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Double blind (participant, investigator)

Number of arms

3

Who may qualify

Ages

18 to 75 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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

   Time frame: Baseline, 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.

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

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

   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.

3. Number of Participants With Laboratory Abnormalities

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

   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).

4. Number of Participants With Vital Sign Abnormalities

   Time frame: Baseline up to Follow-up (44 days)

   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.

5. Number of Participants With Electrocardiogram (ECG) Abnormalities

   Time frame: Baseline up to Follow-up (44 days)

   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).

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

   Time frame: Screening, Baseline, Week 1, 2, 3, 4

   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").

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

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

   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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

46 sites in 1 country: see every site and its status.