Maxigesic 325 Acute Dental Pain Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by AFT Pharmaceuticals, Ltd.
Sponsor:
Information provided by (Responsible Party):
AFT Pharmaceuticals, Ltd.
ClinicalTrials.gov Identifier:
NCT01420653
First received: August 16, 2011
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to determine whether the analgesic effects of Maxigesic USA are greater than acetaminophen, ibuprofen or placebo.


Condition Intervention Phase
Dental Pain
Drug: Maxigesic 325
Drug: Acetaminophen
Drug: Ibuprofen
Drug: Placebo
Phase 3

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: Maxigesic 325 Acute Dental Pain Study: A Double-blind, Placebo-controlled, Randomized, Parallel Group Comparison of the Effects of Maxigesic 325 Versus Acetaminophen, Ibuprofen and Placebo in Participants With Acute Dental Pain

Resource links provided by NLM:


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

Primary Outcome Measures:
  • SPID (Summed Pain Intensity Differences) [ Time Frame: 48 hours afte the first dose ] [ Designated as safety issue: No ]
    The time-adjusted SPIDs (Summed Pain Intensity Differences) of the VAS pain intensity scores up to 48 ours after the first dose of study medication.


Estimated Enrollment: 220
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maxigesic 325
Acetaminophen 325mg + ibuprofen 97.5mg per tablet, two tablets every 6 hours, orally
Drug: Maxigesic 325
Maxigesic USA (acetaminophen 325 mg + ibuprofen 97.5mg), three tablets four times a day with food for 48 hours
Other Name: Maxigesic
Active Comparator: Acetaminophen
Acetaminophen 325mg per tablet (standard dose acetaminophen), two tablets every 6 hours, orally
Drug: Acetaminophen
Acetaminophen 325 mg, 3 tablets four times a day, with food for 48 hours
Other Name: paracetamol
Active Comparator: Ibuprofen
Ibuprofen 97.5mg per tablet (i.e. low dose ibuprofen), two tablets every 6 hours, orally
Drug: Ibuprofen
Ibuprofen 97.5mg, three tablets four times a day, with food for 48 hours.
Other Name: ibuprofen
Placebo Comparator: Placebo
Placebo tablets, every 6 hours, orally
Drug: Placebo
placebo, three tablets four times a day, with food for 48 hours
Other Name: placebo

Detailed Description:

The combination of 500mg acetaminophen and 150mg ibuprofen has been shown to improve analgesia compared with the individual components, when given as 2 tablets (i.e. total of 1,000/300 mg) 4 times a day.

Recent concerns over the safety of acetaminophen have led to some regulatory agencies restricting the maximum dose of acetaminophen per tablet to 325 mg, while maintaining the maximum daily dose of 4000mg per day.

A dosing regimen of three tablets of Maxigesic 325 four times a day gives a total daily dose of 3900mg acetaminophen and 1170mg ibuprofen.

The primary objective of the study is to compare time-adjusted SPID of the VAS pain intensity scores up to 48 hours after the first dose of study medication among the four study groups.

Secondary objectives are:

To compare the time to onset of pain relief after the first dose of study drug defined as (i) perceptible and (ii) meaningful pain relief among the four study groups using the two stopwatch method.

To compare the maximum VAS pain scores up to 48 hours after the first dose of study medication among the four study groups.

To compare the response rates (response rate to be defined as the percentage of participants who reduce their pain intensity scores by at least 50% compared with the baseline VAS measure) among the four study groups.

To compare the time to peak reduction in VAS pain intensity scores following the first dose of study medication among the four study groups.

To compare the time to requirement for rescue medication among the four study groups.

To compare the percentage of participants who use rescue medication among the four study groups.

To compare the amount of rescue medication used (defined as number of tablets) among the four study groups.

To compare the categorical global pain rating among the four study groups.

Safety:

To compare adverse event rates for the 48-hour study period and up to Day 30 among the four treatment groups.

To compare the incidence of known specific NSAID and paracetamol side effects (e.g. GI ulceration or bleeding, indigestion/stomach pain, post-operative bleeding, bronchospasm, skin rashes, water retention, renal failure, thromboembolic events and evidence of clinical hepatitis) during the 48-hour study period and up to Day 30 among the four study groups.

Planned hospital admissions and/or surgical operations for an illness or disease which existed before the study drug was given or the participant was randomized in the study will not be considered adverse events.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provides written informed consent before initiation of any study-related procedures.
  • Males and females aged at least 10 years and not more than 60 years old on the day of consent.
  • Undergoing dental surgery for the extraction of at least 2 impacted third molar teeth.
  • A resting VAS pain intensity score at baseline (within 6 hours after the completion of surgery) of greater than or equal to 40 mm on a 100 mm VAS scale with 0 = no pain and 100 = worst pain imaginable.

Exclusion Criteria:

  • Has taken any NSAID or acetaminophen within 12 hours prior to the stat of surgery other than asprin less than or equal to 150 mg/day
  • Subjects who have received any anaesthetics within 24 hours prior to surgery
  • Hypersensitivity to opioids
  • Known to be pregnant or possibly pregnant
  • Women of childbearing potential who are unwilling to take adequate contraceptive precautions, i.e., hormonal contraceptive, an intrauterine device, double-barrier method, or abstinence. A women 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.
  • Women of childbearing potential who are unwilling to undergo an urine pregnancy test.
  • 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 the 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 < 50 kg or > 120 kg.
  • Has a history of drug or alcohol abuse.
  • Suffering from any other disease or condition which, in the opinion of the investigator, means that it would not be in the participants best interests to participant in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420653

Locations
New Zealand
Clinical Trial New Zealand Recruiting
Hamilton, Waikato, New Zealand
Contact: Eileen Bisley    +64 7 843 0105    eileen@waikatoclinicalresearch.com   
Contact: John Currie, Doctor    + 64 7 843 0105    eileen@waikatoclinicalresearch.com   
Principal Investigator: John Currie, Doctor         
Southern Clinical Trials Recruiting
Christchurch, New Zealand
Contact: Simon Carson, MD    + 64 9 3371 979    simon@sctrials.co.nz   
Contact: Julia Mathieson    + 64 3 3371 979    julia@sctrials.co.nz   
Principal Investigator: Simon Carson, MD         
Sponsors and Collaborators
AFT Pharmaceuticals, Ltd.
Investigators
Principal Investigator: John Currie, Doctor Clinical Trial New Zealand
  More Information

No publications provided

Responsible Party: AFT Pharmaceuticals, Ltd.
ClinicalTrials.gov Identifier: NCT01420653     History of Changes
Other Study ID Numbers: AFT-MX-6
Study First Received: August 16, 2011
Last Updated: July 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Signs and Symptoms
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
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 September 18, 2014