Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain
12 juli 2012 bijgewerkt door: Pfizer
Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Post-Surgical Dental Pain: Study I
This study will compare the pain relieving effect of a single-dose of a novel ibuprofen formulation to placebo and two formulations of standard ibuprofen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
335
Fase
- Fase 3
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
16 jaar tot 40 jaar (Kind, Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Normal, healthy males and females 16 to 40 years of age
- Outpatients who have moderate to severe post-operative pain (confirmed by a Visual Analog Scale-Pain Severity Rating [VAS-PSR] score of at least 50 mm on a 100 mm VAS-PSR) following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
- Use of only the following pre-operative medication(s)/anesthetic(s): topical benzocaine, a short acting parenteral (local) anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide
Exclusion Criteria:
- Pregnancy or breast-feeding
- Alcohol or substance abuse
- Any serious medical or psychiatric disorder
- History of stomach ulcers, stomach bleed, or other bleeding disorders
- Use of a prescription or over-the-counter drug with which administration of ibuprofen or any other non-steroidal anti-inflammatory drug, acetaminophen, or hydrocodone is contraindicated (including: opioids, antipsychotics, antianxiety agents, or other central nervous system depressants[including alcohol])
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Behandeling A
|
Eenmalige dosis nieuw ibuprofen (gelijk aan 400 mg ibuprofen)
|
|
Actieve vergelijker: Behandeling B
|
Single-dose of standard ibuprofen (400mg)
|
|
Actieve vergelijker: Behandeling C
|
Single-dose of standard ibuprofen (400mg)
|
|
Placebo-vergelijker: Treatment D
|
Eenmalige dosis placebo
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8)
Tijdsspanne: 0 to 8 hours
|
SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 8 hours.
SPRID 0-8 score range: -8 (worst) to 56 (best).
PRID: sum of Pain intensity differences (PID) and pain relief rating (PRR) at each time point.
PRID score range: -1=worst to 7=best.
PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe).
PID score range: -1(worst) to 3 (best).
PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
|
0 to 8 hours
|
|
Time to Onset of Meaningful Relief
Tijdsspanne: 0 to 8 hours
|
Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief.
Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered.
|
0 to 8 hours
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time to Confirmed First Perceptible Relief
Tijdsspanne: 0 to 8 hours
|
Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief.
Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered.
The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.
|
0 to 8 hours
|
|
Pain Relief Rating (PRR)
Tijdsspanne: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
PRR was evaluated at different time points during the study up to 8 hours after taking the study medication, and immediately before rescue medication was taken (if necessary).
PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.
|
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
|
Pain Intensity Difference (PID)
Tijdsspanne: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]).
Total possible score range for PID: -1 (worst) to 3 (best).
|
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
|
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
Tijdsspanne: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
PRID was sum of PID and PRR at each post-dosing time point.
The overall possible score range, for PRID was -1 (worst) to 7 (best).
PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]).
Total possible score range for PID: -1 (worst) to 3 (best).
PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).
|
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
|
Time-weighted Sum of Pain Intensity Difference (SPID)
Tijdsspanne: 0-2, 0-3, 0-6, 0-8 hours
|
SPID: time-weighted sum of PID over 2, 3, 6 and 8 hours.
SPID scores range was -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, -6 (worst) to 18 (best) for SPID 0-6, -8 (worst) to 24 (best) for SPID 0-8.
PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe).
Total score range for PID: -1(worst) to 3 (best).
|
0-2, 0-3, 0-6, 0-8 hours
|
|
Time-weighted Sum of Pain Relief Rating (TOTPAR)
Tijdsspanne: 0-2, 0-3, 0-6, 0-8 hours
|
TOTPAR: time-weighted sum of PRR scores over 2, 3, 6 and 8 hours.
TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, 0 (worst) to 24 (best) for TOTPAR 0-6, 0 (worst) to 32 (best) for TOTPAR 0-8.
PRR was evaluated at different time points during the study up to 8 hours, and immediately after taking rescue medication (if necessary).
PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.
|
0-2, 0-3, 0-6, 0-8 hours
|
|
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
Tijdsspanne: 0-2, 0-3, 0-6, 0-8 hours
|
SPRID: time-weighted sum of PRID over 2, 3, 6 and 8 hours.
SPRID score range:-2 (worst) to 14(best) for SPRID 0-2, -3(worst) to 21(best) for SPRID 0-3, -6(worst) to 42(best) for SPRID 0-6, -8(worst) to 56(best) for SPRID 0-8.
PRID:sum of PID and PRR at each time point.
Total score range for PRID: -1=worst to 7=best.
PID:baseline pain severity score minus pain severity score at given time(score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe).
Total score range for PID: -1(worst) to 3(best), PRR: scored on 5-point pain relief rating scale(0=No relief to 4=Complete relief).
|
0-2, 0-3, 0-6, 0-8 hours
|
|
Cumulative Percentage of Participants With Meaningful Relief
Tijdsspanne: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief.
Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered.
|
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
Tijdsspanne: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
Percentage of participants with first perceptible relief was evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief.
Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered.
The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.
|
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
|
Time to Treatment Failure
Tijdsspanne: 0 to 8 hours
|
Median time of dropping out of the participants from the study due to lack of efficacy or rescue medication, whichever came first.
|
0 to 8 hours
|
|
Cumulative Percentage of Participants With Treatment Failure
Tijdsspanne: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.
|
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
|
Cumulative Percentage of Participants With Complete Relief
Tijdsspanne: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.
|
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
|
Participant Global Evaluation of Study Medication
Tijdsspanne: 8 hours
|
Participant global evaluation of study medication was performed at the 8-hour time point or immediately before taking the rescue medication.
It was scored on a 6-point categorical scale where 0 = Very poor, 1 = Poor, 2 = Fair, 3 = Good, 4 = Very Good, and 5 = Excellent.
|
8 hours
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. doi: 10.1080/00325481.2015.993268. Epub 2014 Dec 15.
- Brain P, Leyva R, Doyle G, Kellstein D. Onset of analgesia and efficacy of ibuprofen sodium in postsurgical dental pain: a randomized, placebo-controlled study versus standard ibuprofen. Clin J Pain. 2015 May;31(5):444-50. doi: 10.1097/AJP.0000000000000142.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2010
Primaire voltooiing (Werkelijk)
1 juli 2010
Studie voltooiing (Werkelijk)
1 augustus 2010
Studieregistratiedata
Eerst ingediend
1 april 2010
Eerst ingediend dat voldeed aan de QC-criteria
1 april 2010
Eerst geplaatst (Schatting)
5 april 2010
Updates van studierecords
Laatste update geplaatst (Schatting)
17 augustus 2012
Laatste update ingediend die voldeed aan QC-criteria
12 juli 2012
Laatst geverifieerd
1 juli 2012
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pijn
- Neurologische manifestaties
- Stomatognatische ziekten
- Tand ziekten
- Gezichtspijn
- Kiespijn
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Agenten van het perifere zenuwstelsel
- Enzymremmers
- Pijnstillers
- Sensorische systeemagenten
- Ontstekingsremmers, niet-steroïde
- Pijnstillers, niet-narcotisch
- Ontstekingsremmende middelen
- Antireumatische middelen
- Cyclo-oxygenaseremmers
- Ibuprofen
Andere studie-ID-nummers
- AH-09-10
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .