Anxiety prior to Dental Procedure MedDRA version: 8.0 Level: LLT Classification code 10002758
Conditions
Interventions
Trade Name: Lyrica
Product Name: Lyrica
Product Code: PD0144723(CI-1008)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pregaba
Sponsors
Pfizer Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female outpatients 18 years of age and older 2. A total score of 12 points or more on the Dental Anxiety Scale at screening and baseline evaluations 3. Subject has a scheduled appointment for an elective minor dental procedure (e.g. extraction, odontectomy, apicoectomy, dental filling) 4. Females of childbearing potential must have negative urine pregnancy tests at screening and baseline and be practicing an effective form of contraception (accepted methods are hormonal [oral contraceptive or injectable contraceptive], double barrier with spermicide, or intrauterine device-IUD). Complete abstinence may be considered acceptable, but must first be discussed on a case-by-case basis with the Pfizer monitor prior to any screening tests or procedures for the study 5. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial 6. Subjects who are willing and able to comply with scheduled visits, treatment plan, and other trial procedures 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or lactating 2. Current diagnosis of any of the DSM-IV anxiety disorders as assessed by the M.I.N.I. at screening 3. Current diagnosis of major depressive disorder, dysthymia, schizophrenia or any other psychotic disorder, bipolar disorder, delirium, dementia, or body dysmorphic disorder, and eating disorders as assessed by the M.I.N.I. at screening 4. History of alcohol and/or substance abuse/dependence in the past 5 years as assessed by theM.I.N.I. at screening 5. Subjects considered by the investigator to be at serious risk for suicide or aggressive behavior 6. Mental condition, including mental retardation, rendering the individual unable to understand the nature, scope, and possible consequences of the study and/or constituting evidence of an uncooperative attitude 7. Other DSM-IV Axis-I or Axis III (medical) diagnoses that the investigator judges to be the primary source of anxiety for the subject 8. A history of a seizure disorder, except febrile seizures of childhood 9. Current diagnosis of neuropathic pain 10. Any serious or uncontrolled medical illness, in the opinion of the investigator, which will render the subject unsuitable for the study 11. A urine toxicology screen at screening and/or baseline visit/s positive for any of the following substances or classes of compounds: alcohol, benzodiazepines, amphetamines, barbiturates, opiates, methadone, cocaine, phencyclidine (PCP), cannabinoids 12. Known sensitivity to pregabalin, other drugs structurally related to the neurotransmitter GABA, alprazolam, or other benzodiazepines 13. Presence or history of narrow angle glaucoma 14. History of non-response to alprazolam, other benzodiazepines, gabapentin or pregabalin given for the treatment of anxiety 15. Antidepressant, anxiolytic, antipsychotic, sedative (other than zopiclone or zolpidem for insomnia), hypnotic or psychoactive drug use (including pregabalin and gabapentin) within 2 weeks (5 weeks for fluoxetine) prior to baseline visit. If medication is required for the treatment of insomnia in the week prior to baseline visit, zopiclone (3.75 mg per night) or zolpidem (5 mg per night) may be taken intermittently (prn) on two or fewer nights until 3 days before baseline visit 16. Sedating antihistamine use within 24 hours prior to the Baseline visit. 17. Daily and/or regular use (longer than two months) of benzodiazepines at any dose within the past two years and/or subjects who may have developed a tolerance to alprazolam. 18. Depot neuroleptics administered within the previous 6 months of baseline visit 19. All herbal psychoactive treatments within 14 days of baseline visit 20. Electroconvulsive therapy (ECT) within six (6) months prior to study entry 21. Subjects who began non-medication interventional therapy for anxiety within 2 months of the study: biofeedback, hypnosis, cognitive behavior therapy eg. 22. Participation in any other studies involving investigational or marketed products, concomitantly or within 3 months prior to entry in the study 23. In the judgment of the investigator the subject is unable or unlikely to follow the pr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to assess the anxiolytic efficacy at 4 hours post-dose of pregabalin and alprazolam IR versus placebo in subjects experiencing anxiety prior to dental procedure.;Secondary Objective: The secondary objective of the trial is to document the safety and tolerability profile of pregabalin and alprazolam IR versus placebo in subjects treated for dental anxiety. Sedation status will be actively assessed.;Primary end point(s): A Visual Analogue Scale (VAS) (Appendix 17.2 of the protocol) will be administered to capture onset of action measuring reduction in anxiety symptoms at Screening, Baseline, and at 2, 2.5, 3, 3.5, and 4 hours post-dose. | — |
Countries
Germany, United Kingdom
Outcome results
None listed