Efficacy of 300mg Ibuprofen Prolonged-Release Tablets for the Treatment of Pain After Surgical Removal of Impacted Third Molars

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single centre, randomised, double-blind, double-dummy, parallel group, multiple-dose, active and placebo-controlled efficacy study to evaluate the efficacy and safety of 2×300mg ibuprofen Prolonged Release (PR) tablets in subjects with postoperative dental pain.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Reckitt Benckiser Healthcare (UK) Limited
• Collaborator: Premier Research Group plc
• Treatments: Ibuprofen

Criteria

Inclusion Criteria:

• Is male or female ≥ 18 and ≤ 50 years of age.

• Requires extraction of 2 or more third molars. At least 1 of the third molars must be a fully or partially bone impacted mandibular molar. If only 2 molars are removed, then they must be ipsilateral.

• Experiences moderate to severe pain intensity within 6 hours after surgery, as measured by a numeric rating scale (NRS) score of ≥ 5 on a 0-10 scale.

• Has a body weight ≥ 45 kg and a body mass index (BMI) ≤ 35 kg/m2.

• Female subjects of child-bearing potential must be willing to use a highly effective method of contraception throughout the study. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as the following:

1. surgical sterilisation

2. contraceptive implants or injectables

3. combined oral contraceptives

4. some intrauterine devices (IUDs)

5. true sexual abstinence, when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence such as calendar, ovulation, symptothermal, or post-ovulation methods; declaration of abstinence for the duration of the trial; or withdrawal are not acceptable methods of contraception), or

6. vasectomised partner. To be considered not of child-bearing potential, females must be surgically sterile (defined as bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or post-menopausal (defined as no menses for 12 months in women not using hormonal contraception or hormone replacement therapy, confirmed by a follicle stimulating hormone (FSH) level in the postmenopausal range at Screening).

• Free of clinically significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ECG.

• Is able to provide written informed consent.

• Is willing and able to comply with study requirements (including diet and smoking restrictions), complete the pain evaluations, remain at the study site overnight, and return for followup 7 (± 2) days after surgery.

Exclusion Criteria:

• Known hypersensitivity reactions or allergy (e.g., asthma, rhinitis, angioedema or urticaria) in response to nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen), acetylsalicylic acid (aspirin), ingredients of the study drug, or any other drugs used in the study, including anaesthetics and antibiotics that may be required on the day of surgery.

• A history of active or previous peptic ulceration/ haemorrhage, gastrointestinal bleeding or perforation, heart failure, renal or hepatic failure, uncontrolled hypertension, asthma, nasal polyps, or chronic rhinitis.

• Has complications from the tooth extraction or any other clinically significant medical history that, in the opinion of the investigator, would affect the subject's ability to comply or otherwise contraindicate study participation, including but not limited to the following: cardiac, respiratory, gastroenterological, neurological, psychological, immunological, haematological, oncological, or renal disease.

• Has undergone another dental surgery within 60 days prior to the day of surgery.

• A positive urine drugs of abuse screen or alcohol breathalyser test at screening and during the study (with the exception of a positive drugs of abuse screen that is a consequence of permitted prescription medicines).

• If female, has a positive pregnancy test at screening (serum) or on the day of surgery prior to surgery (urine), or is lactating.

• Has known or suspected, (in the opinion of the investigator), history of alcoholism or drug abuse within 2 years of screening or evidence of tolerance or physical dependence before dosing with study drug.

• Taking any concomitant medications that might confound assessments of pain relief, such as psychotropic drugs, antidepressants, sedative-hypnotics (other than those permitted for conscious sedation), or other analgesics taken within five times of their elimination half-lives. Selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) are permitted if the subject has been on a stable dose for at least four weeks prior to Visit 1 (screening).

• Is considered by the investigator, for any reason (including, but not limited to the risks described as precautions, warnings and contraindications in the current version of the investigator's brochure (IB) for 300 mg ibuprofen PR tablets), to be an unsuitable candidate to receive the study drug.

• Has a history of chronic use (defined as daily use for > 2 weeks) of nonsteroidal anti-inflammatory (NSAIDs), opiates, or glucocorticoids (except inhaled nasal steroids and topical corticosteroids), for any condition within 6 months before dosing with study drug.

• Has significant difficulties swallowing capsules or tablets or is unable to tolerate oral medication.

• Previously participated in another clinical study of 300 mg ibuprofen PR tablets, or received any investigational drug, device, or therapy within 90 days before screening.

• Enrolment of the Investigator, his / her family members, employees and other dependent persons.

• Failure to satisfy the investigator of fitness to participate for any other reason.