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    Summary
    EudraCT Number:2014-004176-35
    Sponsor's Protocol Code Number:AH-09-10
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-06-26
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2014-004176-35
    A.3Full title of the trial
    Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Post Surgical Dental Pain: Study I
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study Evaluating A New Ibuprofen Formulation In The Treatment Of Dental Pain
    A.4.1Sponsor's protocol code numberAH-09-10
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01098747
    A.5.4Other Identifiers
    Name:B3411004Number:B3411004
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York, New York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number18007181021
    B.5.5Fax number13037391119
    B.5.6E-mailClinicalTrials.govCallCenter@pfizer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Advil Film Coated Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAdvil Film-Coated Tablets
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIBUPROFEN SODIUM
    D.3.9.1CAS number 31121-93-4
    D.3.9.3Other descriptive nameIBUPROFEN SODIUM
    D.3.9.4EV Substance CodeSUB21665
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number256
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Post Surgical Dental Pain
    E.1.1.1Medical condition in easily understood language
    Dental Extraction Pain
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of a single-dose of a novel ibuprofen formulation, ibuprofen sodium tablets (IBU Na; 2 x 256 mg [equivalent to 400 mg ibuprofen]) in the third molar extraction model of dental pain compared to a single-dose of 1) Advil Tablets, (standard ibuprofen; 2 x 200 mg), 2) Motrin IB (standard ibuprofen; 2 x 200 mg), and 3) placebo.
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females 16 years to 40 years of age (inclusive).
    2. Outpatients who have moderate to severe post-operative pain (confirmed by a Visual Analog Scale Pain Severity Rating Scale (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.
    3. 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.
    4. Examined by the attending dentist or physician and medically cleared to participate in the study.
    5. In general good health and have no contraindications to the study or rescue medication.
    6. Reliable, cooperative, and of adequate intelligence to record the requested information on the analgesic questionnaire form.
    7. Subjects (or the parent or legal guardian of subjects under the age of 18 years) are required to read, comprehend, and sign the informed consent. Subjects requiring a parent or legal guardian to sign the informed consent form will also be required to sign an assent.
    E.4Principal exclusion criteria
    1.Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder determined by the Principal Investigator to place the subject at increased risk.
    2.Use of a prescription or over-the-counter (OTC) drug with which administration of ibuprofen or any other non-steroidal anti-inflammatory drug (NSAID), acetaminophen (APAP), or hydrocodone is contraindicated (including: opioids, antipsychotics, antianxiety agents, or other central nervous system depressants [including alcohol]).
    3. Use of prescription or OTC antihistamines within 24 hours prior to taking study medication. (Note exceptions: loratadine [Claritin], desloratadine [Clarinex], cetirizine [Zyrtec ], levocetirizine [Xyzal], fexofendadine [Allegra], and azelastine [Intranasal, Astelin]).
    4. Use of a bisphosphonate (e.g., pamidronate [Aredia], risedronate [Actonel], alendronate [Fosamax], or ibandronate [Boniva]) in the past 5-years.
    5. Acute localized dental alveolar infection at the time of surgery that could confound the post-surgical evaluation.
    6. Female subjects who are pregnant, lactating, of child-bearing potential or post-menopausal for less than 2 years and not using a medically approved method of contraception (i.e., oral, transdermal, or implanted contraceptives, intrauterine or intravaginal device [IUD or NuvaRing ], diaphragm, condom, abstinence, or surgical sterility including partner’s vasectomy), or who test positive on a urine-based pregnancy test.
    7. Presence or history (within 2 years of enrollment) of gastrointestinal ulcer or gastrointestinal bleeding.
    8. Presence or history (within 2 years of enrollment) of a bleeding disorder.
    9. Presence or history of alcohol (3 or more alcoholic drinks per day on a regular basis) or substance abuse within 2 years of enrollment (note: one drink of alcohol is 1 oz. liquor, 6 oz. wine, or 12 oz. beer) or currently abusing other mood-altering drugs (e.g., cannabis). Patients who are taking St. John’s Wort, or any other nutritional supplement known to have psychotropic effects may be enrolled if they have been on stable doses of medication for at least 2 months, will maintain this dose throughout the study, and their condition is judged by the Principal Investigator to be well-controlled.
    10. Habituation to analgesic medications (i.e., routine use of oral analgesics 5 or more times per week).
    11. Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP, hydrocodone, other opioids, or to their combinations.
    12. Prior use of any type of analgesic or Non-Steroidal Anti Inflammatory Drug (NSAID) within five half-lives of that drug or less before taking the first dose of study medication, except for pre-anesthetic medication and anesthesia for the procedure.
    13. Currently taking a monoamine oxidase inhibitor (MAOI), antipsychotic, or any other neuroleptic or has taken:
    • A MAOI within 2 months of screening (Note: subjects may not discontinue taking an MAOI solely for the purpose of qualifying for the study)
    • An antipsychotic or other neuroleptic within 14 days of surgery (Note: subjects may not discontinue taking these medications solely for the purpose of qualifying for the study)
    14. Patients who are currently taking any selective serotonin reuptake inhibitor (SSRI), selective norepinephrine reuptake inhibitor (SNRI), or tricyclic antidepressant (TCA) and are not on a stable dose of this medication for at least 30 days or will not maintain this dose throughout the study and their condition is judged by the Principal Investigator to not be well-controlled (Note: subjects may not discontinue taking these medications solely for the purpose of qualifying for the study).
    15. Subjects who have ingested any caffeine-containing beverages, chocolate, or alcohol within 4 hours prior to taking study medication.
    16. Inability or unwillingness to comply with the requirements of the protocol as judged by the Principal Investigator.
    17. The subject has taken an investigational product or participated in an investigational trial within 30 days of study enrollment.
    18. The subject has previously been entered into this study.
    19. The subject is a member of the study site staff directly involved with the study, an employee of the Sponsor, or a relative of study site personnel directly involved with the study or Sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8)

    Time to Onset of Meaningful Relief
    0 to 8 hours
    E.5.1.1Timepoint(s) of evaluation of this end point
    0 to 8 hours

    0 to 8 hours
    E.5.2Secondary end point(s)
    - Time to Confirmed First Perceptible Relief
    - Pain Relief Rating (PRR)
    - Pain Intensity Difference (PID)
    - Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
    - Time-weighted Sum of Pain Intensity Difference (SPID)
    - Time-weighted Sum of Pain Relief Rating (TOTPAR)
    - Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
    - Cumulative Percentage of Participants With Meaningful Relief
    - Cumulative Percentage of Participants With Confirmed First Perceptible Relief
    - Time to Treatment Failure
    - Cumulative Percentage of Participants With Treatment Failure
    - Cumulative Percentage of Participants With Complete Relief
    - Participant Global Evaluation of Study Medication
    E.5.2.1Timepoint(s) of evaluation of this end point
    0 to 8 hours

    0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours

    0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours

    0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours

    0-2, 0-3, 0-6, 0-8 hours

    0-2, 0-3, 0-6, 0-8 hours

    0-2, 0-3, 0-6, 0-8 hours

    0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours

    0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours

    0 to 8 hours

    0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours

    0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours

    8 hours
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 111
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 111
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 205
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects less than 18 years of age
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 316
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    NONE
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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