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PF-06372865 In Subjects With Chronic Low Back Pain

4. november 2016 oppdatert av: Pfizer

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

PF-06372865 In Subjects With Chronic Low Back Pain

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

302

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Mesa, Arizona, Forente stater, 85202
        • Agave Clinical Research, LLC
      • Phoenix, Arizona, Forente stater, 85023
        • Arizona Research Center, Inc.
    • California
      • Anaheim, California, Forente stater, 92804
        • Global Research
      • Fresno, California, Forente stater, 93710
        • Neuro-Pain Medical Center
      • North Hollywood, California, Forente stater, 91606
        • Providence Clinical Research
      • Wildomar, California, Forente stater, 92595
        • Elite Clinical Trials, Incorporate
    • Connecticut
      • Stamford, Connecticut, Forente stater, 06905
        • Stamford Therapeutics Consortium
    • Florida
      • DeLand, Florida, Forente stater, 32720
        • Avail Clinical Research, LLC
      • Fort Lauderdale, Florida, Forente stater, 33306
        • S&W Clinical Research
      • Gainesville, Florida, Forente stater, 32605
        • Florida Research Network, LLC
      • Hollywood, Florida, Forente stater, 33024
        • Broward Research Group
      • Jacksonville, Florida, Forente stater, 32216
        • Jacksonville Center for Clinical Research
      • Orlando, Florida, Forente stater, 32806
        • Compass Research, LLC
      • Pembroke Pines, Florida, Forente stater, 33028
        • Pines Clinical Research Inc.
      • Port Orange, Florida, Forente stater, 32129
        • Accord Clinical Research, LLC
      • South Miami, Florida, Forente stater, 33143
        • Miami Research Associates
      • South Miami, Florida, Forente stater, 33143
        • Arthritis & Rheumatic Care Center
    • Georgia
      • Atlanta, Georgia, Forente stater, 30344
        • Better Health Clinical Research, Inc.
      • Blue Ridge, Georgia, Forente stater, 30513
        • River Birch Research Alliance, LLC
      • Columbus, Georgia, Forente stater, 31904
        • Columbus Regional Research Institute
      • Columbus, Georgia, Forente stater, 31901
        • Family medicine center
      • Marietta, Georgia, Forente stater, 30060
        • Drug Studies America
      • Newnan, Georgia, Forente stater, 30265
        • Better Health Clinical Research, Inc.
      • Newnan, Georgia, Forente stater, 30265
        • Better Health Clinical Research, Inc./Georgia Pain & Spine Care, Inc.
      • Savannah, Georgia, Forente stater, 31405
        • Southeast Regional Research Group
      • Woodstock, Georgia, Forente stater, 30189
        • North Georgia Clinical Research
      • Woodstock, Georgia, Forente stater, 30189
        • North Georgia Internal Medicine
    • Illinois
      • Chicago, Illinois, Forente stater, 60657
        • Chicago Anesthesia Associates
    • Louisiana
      • Lake Charles, Louisiana, Forente stater, 70601
        • Centex Studies, Inc
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02131
        • Boston Clinical Trials
      • Methuen, Massachusetts, Forente stater, 01844
        • ActivMed Practices & Research, Inc.
    • Mississippi
      • Jackson, Mississippi, Forente stater, 39202
        • CRC of Jackson
      • Jackson, Mississippi, Forente stater, 39202
        • Physician's Surgery Center
    • New York
      • Hartsdale, New York, Forente stater, 10530
        • Drug Trials America
      • Rochester, New York, Forente stater, 14618
        • AAIR Research Center
    • North Carolina
      • Raleigh, North Carolina, Forente stater, 27612
        • Wake Research Associates, LLC
      • Raleigh, North Carolina, Forente stater, 27612
        • Wake Internal Medicine Consultants, Inc.
      • Winston-Salem, North Carolina, Forente stater, 27103
        • The Center for Clinical Research
    • Oregon
      • Portland, Oregon, Forente stater, 97210
        • Summit Research Network (Oregon), Inc.
    • Pennsylvania
      • Duncansville, Pennsylvania, Forente stater, 16635
        • Altoona Center for Clinical Research
    • Rhode Island
      • Warwick, Rhode Island, Forente stater, 02886
        • Omega Medical Research
    • Texas
      • Houston, Texas, Forente stater, 77074
        • Clinical Trial Network
      • San Antonio, Texas, Forente stater, 78229
        • Progressive Clinical Research
      • San Antonio, Texas, Forente stater, 78229
        • Lee Medical Associates, PA
    • Virginia
      • Norfolk, Virginia, Forente stater, 23502
        • National Clinical Research - Norfolk, Inc.
    • Washington
      • Seattle, Washington, Forente stater, 98104
        • Summit Research Network (Seattle) Llc

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

-

Exclusion Criteria:

-

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: PF-06372865
Daily BID dosing for 4 weeks
Legemiddel: PF-06372865
Dose level 1 daily dosing BID for 1 week followed by dose level 2 daily BID for 3 weeks
Placebo komparator: Placebo
Daily BID dosing for 4 weeks
Legemiddel: Placebo
Placebo for PF-06372865 and placebo for naproxen daily
Aktiv komparator: Naproxen
Daily BID dosing for 4 weeks
Legemiddel: Naproxen
500 mg BID for 4 weeks

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Daily Low Back Pain Intensity (LBPI) Score as Measured by an 11-point Numeric Rating Scale (NRS) at Week 4
Tidsramme: 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.
Baseline, Week 4
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: 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.
Baseline up to 28 days after the last dose of study treatment (Day 56)
Number of Participants With Laboratory Abnormalities
Tidsramme: 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).
Baseline up to 28 days after the last dose of study treatment (Day 56)
Number of Participants With Vital Sign Abnormalities
Tidsramme: 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.
Baseline up to Follow-up (44 days)
Number of Participants With Electrocardiogram (ECG) Abnormalities
Tidsramme: 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).
Baseline up to Follow-up (44 days)
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Tidsramme: 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").
Screening, Baseline, Week 1, 2, 3, 4
Change From End of Treatment Visit in Physician's Withdrawal Checklist (PWC) Score at Follow-up Visit
Tidsramme: 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.
End of treatment (Day 30), follow-up (Day 44)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
Tidsramme: Baseline, Week 1, 2, 3, 4
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.
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
Tidsramme: Baseline, Week 1, 2, 3, 4
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.
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
Tidsramme: Baseline up to Week 4
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.
Baseline up to Week 4
Number of Participants Withdrawn Due to Lack of Efficacy
Tidsramme: Baseline up to Week 4
Participants withdrew from the study due to lack of efficacy (insufficient clinical response) were reported.
Baseline up to Week 4
Time to Withdrawal Due to Lack of Efficacy
Tidsramme: Baseline up to Week 4
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.
Baseline up to Week 4
Number of Participants Using Rescue Medication
Tidsramme: 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.
Week 1, 2, 3, 4
Number of Days Participants Used the Rescue Medication
Tidsramme: 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.
Week 1, 2, 3, 4
Amount of Rescue Medication Used by the Participants
Tidsramme: 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.
Week 1, 2, 3, 4
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1, 2, and 3
Tidsramme: 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.
Baseline, Week 1, 2, 3
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4
Tidsramme: Baseline, Week 4
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.
Baseline, Week 4
Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4
Tidsramme: 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.
Baseline, Week 2, Week 4
Chronic Low Back Pain (CLBP) Responder Index Analysis
Tidsramme: Week 1, 2, 3, 4
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.
Week 1, 2, 3, 4
Change From Baseline in Participant's Global Assessment (PtGA) of Low Back Pain Score at Week 1, 2, 3 and 4
Tidsramme: 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.
Baseline, Week 1, 2, 3, 4
Patient Global Impression of Change (PGI-C) Score
Tidsramme: 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.
Week 1, 2, 3, 4
Number of Participants With Global Evaluation of Study Medication (GESM) at Week 4
Tidsramme: Week 4
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.
Week 4
Plasma Concentration of PF-06372865
Tidsramme: 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).
Baseline, Week 1, 2, 3, 4
Plasma Concentration of Naproxen
Tidsramme: Baseline, Week 1, 2, 3, 4
Data was calculated by setting concentration values below the LLOQ to zero. The LLOQ was <1000 ng/mL.
Baseline, Week 1, 2, 3, 4

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2014

Primær fullføring (Faktiske)

1. august 2015

Studiet fullført (Faktiske)

1. august 2015

Datoer for studieregistrering

Først innsendt

9. oktober 2014

Først innsendt som oppfylte QC-kriteriene

9. oktober 2014

Først lagt ut (Anslag)

13. oktober 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

4. januar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2016

Sist bekreftet

1. november 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • B7431006

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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