Maxi-Analgesic Phase 2 Study to Compare the Analgesic Effects in Different Dosing Groups to Treat Teeth Extraction Pain

This study has been withdrawn prior to enrollment.
(The study was withdrawn due to administrative reason)
Sponsor:
Information provided by (Responsible Party):
AFT Pharmaceuticals, Ltd.
ClinicalTrials.gov Identifier:
NCT01104844
First received: April 14, 2010
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Dental Pain
Drug: Full Dose Strength
Drug: Quarter dose strength
Drug: Half dose strength
Drug: Acetaminophen standard dose
Drug: Ibuprofen low dose
Drug: Ibuprofen high dose
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multicentre, Double-blind, Placebo-controlled, Randomized, Parallel Group Comparison of the Analgesic Effects of Different Maxigesic Doses Versus Acetaminophen, Ibuprofen and Placebo for the Teeth Extraction Pain

Resource links provided by NLM:


Further study details as provided by AFT Pharmaceuticals, Ltd.:

Primary Outcome Measures:
  • the time-adjusted SPIDs of the VAS pain intensity scores [ Time Frame: 24 hours after the first dose ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • the maximum VAS pain score [ Time Frame: 24 hours after the first dose ] [ Designated as safety issue: No ]
    To compare the maximum VAS pain scores for the 24-hour period after the first dose of study medication among the seven treatment groups to determine the form of the dose response relationship.

  • The Response Rate [ Time Frame: 24 hours after the first dose ] [ Designated as safety issue: No ]
    To compare the response rates (response rate to be defined as the percentage of participants who achieve at least 50% reduction in baseline pain within 6 hours i.e. the first dose period) among the seven treatment groups to determine the form of the dose response relationship.

  • The time to peak reduction in VAS pain intensity scores [ Time Frame: 24 hours after the first dose ] [ Designated as safety issue: No ]
    To determine and compare the time to peak reduction in VAS pain intensity scores following the first dose of study medication among the seven treatment groups to determine the form of the dose response relationship.

  • The time to perceptible and meaningful pain relief [ Time Frame: 24 hours after the first dose ] [ Designated as safety issue: No ]
    To compare time to perceptible and meaningful pain relief among the seven treatment groups using the two stopwatch method.

  • The time to requirement for rescue medication [ Time Frame: 24 hours after the first dose ] [ Designated as safety issue: No ]
    To compare the time to requirement for rescue medication among the seven treatment groups.

  • The amount of rescue medication used [ Time Frame: 24 hours after the first dose ] [ Designated as safety issue: No ]
    To compare the amount of rescue medication used (defined as the number of tablets) among the seven treatment groups over the 24-hour treatment period.

  • The percentage of participants requiring rescue medication [ Time Frame: 24 hours after the first dose ] [ Designated as safety issue: No ]
    To compare the percentage of participants requiring rescue medication among the seven treatment groups.

  • The categorical global pain rating [ Time Frame: 24 hours after the first dose ] [ Designated as safety issue: No ]
    To compare the categorical global pain rating among the seven treatment groups which is obtained at the end of 24 hours study period.

  • The incidence of adverse events [ Time Frame: up to 30 days after the last dose ] [ Designated as safety issue: Yes ]

    Adverse events (divided into serious and non-serious adverse events) will be assessed for the study period. Adverse events will also be determined up to 30 days after the last dose.

    The incidence of individual specific NSAID and acetaminophen side effects (e.g. GI ulceration, indigestion/stomach pain, post-operative bleeding and evidence of clinical hepatitis) will be determined up to 30 days after the last dose.



Enrollment: 0
Arms Assigned Interventions
Active Comparator: Half dose strength
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
Investigational drug half dose strength (acetaminophen 250mg + ibuprofen 75mg) i.e. 2 tablets equating to 1/2 the dose in the standard investigational drug
Other Name: Maxigesic half dose
Active Comparator: Quarter dose strength
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
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.
Other Name: Maxigesic Quarter Dose
Active Comparator: Acetaminophen standard dose
Acetaminophen standard dose 500mg i.e. 2 tablets equating to the same acetaminophen dose as in the standard investigational drug
Drug: Acetaminophen standard dose
Acetaminophen standard dose 500mg i.e. 2 tablets equating to the same acetaminophen dose as in the standard investigational drug
Other Name: paracetamol
Active Comparator: ibuprofen low dose
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 low dose 150mg tablet i.e. 2 tablets equating to the same ibuprofen dose as in the standard investigational product
Other Name: Ibuprofen
Active Comparator: Ibuprofen high dose
Ibuprofen High dose 300mg i.e. 2 tablets equating to twice the ibuprofen dose as in the standard investigational drug
Drug: Ibuprofen high dose
Ibuprofen high dose 300mg i.e. 2 tablet equating to twice the ibuprofen dose as in the standard investigational drug
Other Name: Ibuprofen
Placebo Comparator: placebo
2 Placebo tablets
Drug: Placebo
2 placebo tablets
Other Name: placebo
Experimental: Full Dose Strength
Investigational drug full dose strength (acetaminophen 500mg + ibuprofen 150mg) i.e. 2 tablets
Drug: Full Dose Strength
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)
Other Name: Brand name Maxigesic

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provide written informed consent before initiation of any study-related procedures.
  2. Males and females aged at least 16 years and not more than 40 years old on the day of consent.
  3. Undergoing oral surgery for the extraction of 2 impacted 3rd molar teeth, one of which must be mandibular and require bone removal.
  4. 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.
  5. Baseline VAS pain intensity score of > 50mm on a 100mm VAS scale with 0 = no pain and 100 = worst pain imaginable.

Exclusion Criteria:

Study contra-indications:

  1. Has taken any NSAID or acetaminophen within 12 hours prior to the start of surgery other than aspirin ≤ 150mg/day.
  2. Subjects who have received any anesthetics from midnight the night prior to surgery, except for lidocaine with epinephrine, nitrous oxide, diazepam (Valium®), methohexital (Brevital®).
  3. Known to be pregnant or possibly pregnant.
  4. 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.
  5. 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.
  6. In the opinion of the investigator, unable to understand the visual analogue pain score or comply with the protocol requirements.
  7. Currently or in last 30 days, has been in a clinical trial involving another study drug.
  8. 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.
  9. 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:

  10. Hypersensitivity to aspirin or other NSAID.
  11. Hypersensitivity to acetaminophen.
  12. Severe known hemopoietic, renal or hepatic disease, or immunosuppressed.
  13. 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.).
  14. History of severe asthma defined as asthma requiring frequent or ongoing treatment to control symptoms. Exercise-induced asthma or mild asthma not requiring ongoing treatment may not be exclusionary at the discretion of the investigator.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01104844

Locations
United States, Texas
Austin Clinic
Austin, Texas, United States, 78705
Sponsors and Collaborators
AFT Pharmaceuticals, Ltd.
Investigators
Principal Investigator: Michael Kuss, Doctor Premier Research Group Ltd.
  More Information

Publications:
Responsible Party: AFT Pharmaceuticals, Ltd.
ClinicalTrials.gov Identifier: NCT01104844     History of Changes
Other Study ID Numbers: AFT-MX-3
Study First Received: April 14, 2010
Last Updated: July 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AFT Pharmaceuticals, Ltd.:
dental pain
Analgesia

Additional relevant MeSH terms:
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Signs and Symptoms
Acetaminophen
Ibuprofen
Analgesics
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014