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Injectable Diclofenac for the Prevention of Post-operative Dental Pain (DP4)

28. august 2014 opdateret af: IBSA Institut Biochimique SA

Preliminary Evaluation of the Efficacy and Local Tolerability of Injectable Diclofenac at 5, 12.5, 25 and 50 mg/mL, Administered Locally Prior to Surgery for the Prevention of Post-operative Pain After Third Molar Surgery

This is a prospective, randomised, double-blind, placebo-controlled, parallel group study in approximately 75 patients undergoing surgical removal of an impacted lower third molar.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

75

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
      • Birmingham, Det Forenede Kongerige, B4 6NN
        • The School of Dentistry University of Birmingham

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Out-patients of either gender.
  2. Patients aged ≥ 18 to ≤ 65 years old.
  3. Subjects able and willing to give their written consent prior to inclusion in the study.
  4. Female subjects of childbearing potential must (1) have a negative urine pregnancy test at the inclusion visit, (2) be using an appropriate method of contraception according to the definition of Note of ICH M3 Guideline (implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner), and (3) be willing to continue using the contraceptive method throughout the entire study period.
  5. Subjects must (1) be able to comprehend the full nature and purpose of the study, including possible risks and side effects, (2) fully co-operate with the Investigator, (3) comply with the requirements of the entire study.
  6. Patients undergoing surgical extraction of a single, fully or partially impacted mandibular 3rd molar requiring bone removal.

Exclusion Criteria:

General

  1. Patients refusing to give written informed consent.
  2. Patients not able to understand the purposes of the study or not willing to return for the control visits.
  3. Patients with major psychiatric disorders that, in the investigator's opinion, could compromise study participation.
  4. Patients enrolled in any clinical trial in the previous 3 months.
  5. Employees of the study centre with direct involvement in the proposed study or other studies under the direction of the main investigator or study centre, as well as family members of the employees or investigator.
  6. Pregnant or breast-feeding women.
  7. Alcohol or drug abuse in the previous 12 months.
  8. Clinically significant or unstable concomitant disease whose sequelae might interfere with the study evaluation parameters.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Diclofenac sodium 5 mg/mL
Medicin: Diclofenac sodium
One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Andre navne:
  • Diclofenac HPBCD
Eksperimentel: Diclofenac sodium 12.5 mg/mL
Medicin: Diclofenac sodium
One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Andre navne:
  • Diclofenac HPBCD
Eksperimentel: Diclofenac sodium 25 mg/mL
Medicin: Diclofenac sodium
One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Andre navne:
  • Diclofenac HPBCD
Eksperimentel: Diclofenac sodium 50 mg/mL
Medicin: Diclofenac sodium
One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Andre navne:
  • Diclofenac HPBCD
Placebo komparator: Placebo 1 mL
Medicin: Diclofenac sodium
One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Andre navne:
  • Diclofenac HPBCD

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Area Under the Curve (AUC) of the Pain Scores.
Tidsramme: Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery
Pain will be scored by the patient at the end of surgery (time 0) and at 15-minute intervals after surgery for a total of 6 hours on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).
Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery

Sekundære resultatmål

Resultatmål
Tidsramme
Postsurgical Extra-oral Swelling
Tidsramme: measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
Trismus
Tidsramme: measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
Peak Pain Intensity
Tidsramme: measured from end of surgery up to 12 hours postsurgery
measured from end of surgery up to 12 hours postsurgery
Time to First Use of Rescue Medication.
Tidsramme: measured from end of surgery up to 1 week postsurgery
measured from end of surgery up to 1 week postsurgery
Amount of Rescue Medication
Tidsramme: consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery
consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery
Rescue Medication Consumption
Tidsramme: consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery
consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery
Patient and Investigator Global Evaluation of the Effectiveness of Treatment
Tidsramme: at 6 hour postsurgery and on Day 3
at 6 hour postsurgery and on Day 3
Time to Onset of Pain
Tidsramme: measured from end of surgery up to 12 hours postsurgery
measured from end of surgery up to 12 hours postsurgery
Wound Healing
Tidsramme: at 6 hour postsurgery, and on day 3 and 1 week postsurgery
at 6 hour postsurgery, and on day 3 and 1 week postsurgery
Recurrent Bleeding
Tidsramme: every hour up to 6 hour postsurgery
every hour up to 6 hour postsurgery
Vital Signs
Tidsramme: presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.
presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.
Number of Patients With Adverse Events
Tidsramme: from signature of the informed consent to 1 week postsurgery
from signature of the informed consent to 1 week postsurgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

IBSA Institut Biochimique SA

Efterforskere

  • Ledende efterforsker: Thomas Dietrich, MD, The School of Dentistry, University of Birmingham

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2013

Primær færdiggørelse (Faktiske)

1. maj 2013

Studieafslutning (Faktiske)

1. maj 2013

Datoer for studieregistrering

Først indsendt

1. oktober 2012

Først indsendt, der opfyldte QC-kriterier

12. oktober 2012

Først opslået (Skøn)

15. oktober 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. september 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. august 2014

Sidst verificeret

1. august 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 12UK/DCsc04

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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