Analgesia induced by dental extraction MedDRA version: 8.1 Level: HLT Classification code 10044049 Term: Dental pain and sensation disorders
Conditions
Interventions
Product Name: Theobromine & Sucralose
Product Code: No code used
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: Theobromine (BAN)
Sponsors
GlaxoSmithKline Consumer Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age Aged from 18 years up to 60 years inclusive. 2) Weight A body weight of 50 - 110 kg inclusive. 3) Contraception Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception. They should have been established on this method since last menses or for 30 days prior to the screening visit at the start of the study and for the duration of the study. 4) Diagnosis a) Patients must have a partial or fully impacted lower third molar as verified by oral examination and dental X-rays. b) Experience moderate to severe pain as demonstrated using a VRS and confirmed by VAS (a score of at least 40 mm on a 100 mm scale) after undergoing surgical removal of one partial or fully impacted lower third molar under local anaesthetic. (Patients may also have the ipsilateral maxillary third molar of the upper jaw removed if warranted by the dental surgeon). 5) Compliance Understands and is willing, able and likely to comply with all study procedures and restrictions. 6) Consent Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. 7) General Health Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Pregnancy Women who are pregnant or who have a positive urine pregnancy test. 2) Breast-feeding Women who are breast-feeding. 3) Disease/Illness a) Current or recurrent disease that could affect the action, absorption or disposition of the study medication. b) Current dental oral disease that, in the opinion of the investigator, could cause complications that may affect the study. c) Has any psychiatric or other medical disorders which, in the opinion of the investigator, is likely to prevent completion of the study or to prevent the full understanding and reporting of pain relief. d) Any disease that requires the patient to adhere to a low sodium diet. 4) Medications a) Patients who have taken any analgesics or non-steroidal anti-inflammatory drugs within 24 hrs prior to the administration of the study treatment (48 hrs for long-acting drugs). b) Patients taking any sedative or anxiolytic treatments within 24 hrs prior to administration of study treatment. c) Patients who have taken caffeine-containing food, drinks or medications within 12 hrs prior to administration of the study treatment. d) Use of any medication which, in the opinion of the investigator, is likely to interfere with the action, absorption or disposition of the study treatment e.g. microsomal enzyme inducers, prokinetic agents such as metoclopramide or domperidone. e) Patients for whom the use of ibuprofen, paracetamol or local anaesthetic is contraindicated. 5) Unresponsive to paracetamol Patients who are known, by questioning, to consistently have an inadequate response to paracetamol. 6) Allergy/Intolerance a) Known or suspected intolerance or hypersensitivity to paracetamol, theobromine or excipients of the formulations or any related compounds. b) Known or suspected intolerance or hypersensitivity to the rescue medication, ibuprofen, or to the local anaesthetic used for surgery. 7) Clinical Study/Experimental Medication a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study. b) Previous participation in this study. 8) Substance abuse Recent history (within the last 2 years) of alcohol, analgesic or other substance abuse. Abuse is defined as self reported, diagnosed or treated. 9) Personnel An employee of the sponsor or the study staff at the site or their immediate family.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the analgesic efficacy of theobromine + paracetamol versus paracetamol alone.; Secondary Objective: To summarise pharmacokinetic data (AUC0-6 hrs, Cmax, tmax) for theobromine and for paracetamol (alone and in combination with theobromine). To summarise the frequency of micturation for theobromine + paracetamol and for paracetamol alone. To summarise safety data for theobromine + paracetamol and for paracetamol alone. ; Primary end point(s): Efficacy The primary endpoints in assessing efficacy will be: • Total Pain Relief (TOTPAR) to 1, 2, 4 and 6 hrs. TOTPAR = SUM(Rt x (timet - timet-1)), where Rt = pain relief score at time t, and timet = time in hours. In this proof-of-principle pilot study, consistent trends in favour of paracetamol + theobromine versus paracetamol alone (as measured by total pain relief during the 6 hr assessment period) will be deemed a positive result and may warrant further investigation in a larger study. Safety The assessment of safety will be based on adverse events reported by all patients following dosing with the study medication. | — |
Countries
United Kingdom
Outcome results
None listed