NCT01104844

Brief Summary

The aim of the study is to examine the dose response relationship in the treatment of dental pain (teeth extraction) for the different potential doses of the investigational drug, i.e. 2 tablets, 1 tablet or ½ a tablet given 4 times a day.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2010

Completed
Last Updated

July 12, 2013

Status Verified

July 1, 2013

First QC Date

April 14, 2010

Last Update Submit

July 11, 2013

Conditions

Dental Pain

Keywords

dental painAnalgesia

Outcome Measures

Primary Outcomes (1)

  • the time-adjusted SPIDs of the VAS pain intensity scores

    The primary efficacy objective is to compare the time-adjusted SPIDs of the VAS pain intensity scores up to 24 hours after the first dose of study medication among the 7 treatment groups to determine the form of the dose-response relationship.

    24 hours after the first dose

Secondary Outcomes (9)

  • the maximum VAS pain score

    24 hours after the first dose

  • The Response Rate

    24 hours after the first dose

  • The time to peak reduction in VAS pain intensity scores

    24 hours after the first dose

  • The time to perceptible and meaningful pain relief

    24 hours after the first dose

  • The time to requirement for rescue medication

    24 hours after the first dose

  • +4 more secondary outcomes

Study Arms (7)

Half dose strength

ACTIVE COMPARATOR

Investigational drug half dose strength (acetaminophen 250mg + ibuprofen 75mg), i.e 2 tablets equating to ½ the dose in the standard investigational drug

Drug: Half dose strength

Quarter dose strength

ACTIVE COMPARATOR

Investigational drug quarter dose strength (acetaminophen125mg + Ibuprofen 37.5mg) i.e. 2 tablets equating to ¼ the dose in the standard investigational drug.

Drug: Quarter dose strength

Acetaminophen standard dose

ACTIVE COMPARATOR

Acetaminophen standard dose 500mg i.e. 2 tablets equating to the same acetaminophen dose as in the standard investigational drug

Drug: Acetaminophen standard dose

ibuprofen low dose

ACTIVE COMPARATOR

Ibuprofen low dose 150mg tablet i.e. 2 tablets equating to the same ibuprofen dose as in the standard investigational product

Drug: Ibuprofen low dose

Ibuprofen high dose

ACTIVE COMPARATOR

Ibuprofen High dose 300mg i.e. 2 tablets equating to twice the ibuprofen dose as in the standard investigational drug

Drug: Ibuprofen high dose

placebo

PLACEBO COMPARATOR

2 Placebo tablets

Drug: Placebo

Full Dose Strength

EXPERIMENTAL

Investigational drug full dose strength (acetaminophen 500mg + ibuprofen 150mg) i.e. 2 tablets

Drug: Full Dose Strength

Interventions

Full Dose StrengthDRUG

Acetaminophen + ibuprofen, 2 tablets every 6 hours, with food for 24 hours (i.e a total of 4 x 1000/300 mg doses of study drug comprising of 8 tablets)

Also known as: Brand name Maxigesic
Full Dose Strength
Quarter dose strengthDRUG

Investigational drug quarter dose strength (acetaminophen 125mg + ibuprofen 37.5mg) i.e. 2 tablets equating to 1/4 the dose in the standard investigational drug.

Also known as: Maxigesic Quarter Dose
Quarter dose strength
Half dose strengthDRUG

Investigational drug half dose strength (acetaminophen 250mg + ibuprofen 75mg) i.e. 2 tablets equating to 1/2 the dose in the standard investigational drug

Also known as: Maxigesic half dose
Half dose strength
Acetaminophen standard doseDRUG

Acetaminophen standard dose 500mg i.e. 2 tablets equating to the same acetaminophen dose as in the standard investigational drug

Also known as: paracetamol
Acetaminophen standard dose
Ibuprofen low doseDRUG

Ibuprofen low dose 150mg tablet i.e. 2 tablets equating to the same ibuprofen dose as in the standard investigational product

Also known as: Ibuprofen
ibuprofen low dose
Ibuprofen high doseDRUG

Ibuprofen high dose 300mg i.e. 2 tablet equating to twice the ibuprofen dose as in the standard investigational drug

Also known as: Ibuprofen
Ibuprofen high dose
PlaceboDRUG

2 placebo tablets

placebo

Eligibility Criteria

Age16 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Provide written informed consent before initiation of any study-related procedures.
  • Males and females aged at least 16 years and not more than 40 years old on the day of consent.
  • Undergoing oral surgery for the extraction of 2 impacted 3rd molar teeth, one of which must be mandibular and require bone removal.
  • Experiencing moderate to severe post-operative pain, as defined by a 4 point categorical pain intensity rating scale with 0 = no pain; 1 = mild pain; 2 = moderate pain and 3 = severe pain(at rest) within 6 hours after completion of surgery.
  • Baseline VAS pain intensity score of \> 50mm on a 100mm VAS scale with 0 = no pain and 100 = worst pain imaginable.

You may not qualify if:

  • Study contra-indications:
  • Has taken any NSAID or acetaminophen within 12 hours prior to the start of surgery other than aspirin ≤ 150mg/day.
  • Subjects who have received any anesthetics from midnight the night prior to surgery, except for lidocaine with epinephrine, nitrous oxide, diazepam (Valium®), methohexital (Brevital®).
  • Known to be pregnant or possibly pregnant.
  • Women of childbearing potential who are unwilling to take adequate contraceptive precautions, i.e., a hormonal contraceptive, an intrauterine device, double-barrier method, or abstinence (should the subject become sexually active, she must agree to use a double-barrier method of contraception). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a partial or total hysterectomy or surgical sterilization, e.g., bilateral tubal ligation, bilateral oophorectomy.
  • Suffering from a neurological disorder relating to pain perception or any acute or chronic condition that, in the opinion of the investigator, makes the subject unsuitable from an efficacy or safety perspective.
  • In the opinion of the investigator, unable to understand the visual analogue pain score or comply with the protocol requirements.
  • Currently or in last 30 days, has been in a clinical trial involving another study drug.
  • Currently treated with an ACE inhibitor, warfarin, steroid (other than nasal steroids or topical steroids with the approval of the investigator), cyclosporin, tacrolimus or methotrexate, or any other medication felt by the investigator to interfere with safety or efficacy evaluations.
  • Participant weight \< 50kg.Suffering from any other diseases or condition which, in the opinion of the investigator, means that it would not be in the participant's best interests to participate in this study.
  • NSAID and/or acetaminophen contra-indications:
  • Hypersensitivity to aspirin or other NSAID.
  • Hypersensitivity to acetaminophen.
  • Severe known hemopoietic, renal or hepatic disease, or immunosuppressed.
  • History of gastric ulceration or other GI disorders that, in the opinion of the investigator make the subject unsuitable (e.g., frequent treatment of GERD, inflammatory bowel disease, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Austin Clinic

Austin, Texas, 78705, United States

Location

Related Publications (2)

  • Merry AF, Gibbs RD, Edwards J, Ting GS, Frampton C, Davies E, Anderson BJ. Combined acetaminophen and ibuprofen for pain relief after oral surgery in adults: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):80-8. doi: 10.1093/bja/aep338.

    PMID: 20007794BACKGROUND

  • Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8.

    PMID: 20142348BACKGROUND

MeSH Terms

Conditions

ToothacheAgnosia

Interventions

AcetaminophenIbuprofen

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesFacial PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • Michael Kuss, Doctor

    Premier Research Group Ltd.

    PRINCIPAL INVESTIGATOR
0

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

April 14, 2010

First Posted

April 16, 2010

Last Updated

July 12, 2013

Record last verified: 2013-07

Locations

US(1)