Pain associated with prostate biopsy. MedDRA version: 16.0 Level: PT Classification code 10004857 Term: Biopsy prostate System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Name: OX51-3
Product Code: OX51-3
Pharmaceutical Form: Sublingual tablet
INN or Proposed INN: ALFENTANIL HYDROCHLORIDE
CAS Number: 69049-06-5
Concentration unit: µg microgram(s)
Concentration
Sponsors
Orexo AB
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Men 18 to 85 years of age at the time of eligibility at Visit 1. 2. Signed informed consent obtained. 3. Abnormal digital rectal examination and/or elevated total prostate-specific antigen (tPSA) value > 4.0 ng/mL or increased Prostate-Specific Antigen (PSA) velocity based on Investigator judgment for biopsy. 4. Body mass index (BMI) between 19.0 and 34.0 kg/m2 inclusive. 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Previous prostate biopsy. 2. Prior radiation therapy to pelvis. 3. Anal fissure, anal stricture or any other anorectal pathology that may interfere with the prostate biopsy procedure, as judged by the Investigator. 4. Suspected urinary tract infection or recent (within 30 days) active urological infection (e.g., prostatitis). 5. Any known hypersensitivity or contraindication to alfentanil, other opioids or local anaesthetics. 6. A history or presence of drug or alcohol abuse. 7. Concomitant or prior use of opioids within 2 weeks prior to IMP administration. 8. Concomitant or prior use of any analgesic treatment for pain within 24 hours prior to IMP administration. 9. Concomitant or prior use of any sedating medications (e.g. barbiturates, benzodiazepines, neuroleptics, antihistamines) within 24 hours prior to IMP administration. 10. Concomitant use of monoamine oxidase inhibitors (e.g. Aurorix/moklobemid). 11. Concomitant or prior use of medium to strong cytochrome P450 (CYP) 3A4 enzyme inhibitors or 3A4 enzyme inducers within 14 days prior to IMP administration (pre-biopsy administration of antibiotics according to site standard practice is allowed, except for clarithromycin, erythromycin, telithromycin and rifampin/rifampicin. See Appendix 13.2 for prohibited medications). 12. Bleeding diathesis. 13. Anticoagulant treatment (aspirin up to max 160 mg/day is allowed). 14. Chronic pain and/or need of chronic pain treatment. 15. Current pain as measured by a score of > 3 on an 11-items Numerical Rating Scale (NRS). 16. Severe airway and lung disease such as symptomatic asthma, chronic bronchitis, emphysema or sleep apnea syndrome. 17. A history of any seizure disorder (other than febrile seizures). 18. A history of significant liver or renal disease. 19. A history of hypothyreosis. 20. Clinically significant cardiac disease or central nervous system disease. 21. Clinically significant abnormality detected in the patient?s physical examination, vital signs (including clinically significant abnormal orthostatic blood pressure) or 12-lead ECG as judged by the investigator. 22. History and/or presence of any somatic disease/condition that may interfere with the objectives of the trial as judged by the Investigator. 23. Participation in any other trial involving an IMP within 3 months before assessment of eligibility at Visit 1. 24. Otherwise not suitable to participate in the trial in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the analgesic efficacy of sublingual alfentanil tablets in patients who undergo prostate biopsy;Secondary Objective: 1.To evaluate the safety and tolerability of sublingual alfentanil tablets. 2.To evaluate the patients' sedation after administration of sublingual alfentanil tablets. 3.To evaluate the relationship between dose and analgesic efficacy of sublingual alfentanil tablets in patients who undergo prostate biopsy. 4.To evaluate the post-procedural pain. 5.To evaluate the patients' and clinicians' satisfaction with the pain treatment of the procedure. 6.To evaluate the need for rescue medication. 7.To evaluate the PK profile of the sublingual alfentanil tablets in the target patient population. 8.To evaluate the post-procedural recovery time.;Primary end point(s): 1. Worst pain intensity experienced during prostate biopsy measured immediately after end of prostate biopsy procedure by Numerical Rating Scale (NRS), Direction #2.;Timepoint(s) of evaluation of this end point: immediately after end of prostate biopsy procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. AEs, ECGs, pulse rate, blood pressure, respiratory rate, oxygen saturation (measured by pulse oximetry (SpO2)) and visual inspection of the oral mucosa. 2a. Independent observer assessment of patient sedation by using Pasero Opioid-induced Sedation Scale (POSS) prior to Investigational Medicinal Product (IMP) administration, at 5-10 minutes after IMP administration and at 10, 30, 60, 90, 120 and 240 minutes after end of prostate biopsy procedure. 2b. Patient subjective assessment of sedation by using Patient Global Impression of Drowsiness (PGID) prior to IMP administration, at 5-10 minutes after IMP administration and at 10, 30, 60, 90, 120 and 240 minutes after end of prostate biopsy procedure. 3. Worst pain intensity experienced during prostate biopsy measured immediately after end of prostate biopsy procedure by NRS. 4. Pain intensity measured at 10, 30, 60, 90 and 240 minutes after end of prostate biopsy procedure, measured by NRS, Direction #3. 5. Patient Global Impression of Satisfaction (PGIS) and Clinician Global Impression of Satisfaction (CGIS) measured 90 minutes after end of prostate biopsy procedure. 6. Percentage of patients receiving rescue medication. 7. PK parameters 8. Recovery criteria by Aldrete score prior to IMP administration and at 10, 30, 60, 90, 120, 180 and 240 minutes after end of prostate biopsy procedure. ;Timepoint(s) of evaluation of this end point: 1. Measured during procedure 2a.prior to Investigational Medicinal Product (IMP) administration, at 5-10 minutes after IMP administration and at 10, 30, 60, 90, 120 and 240 minutes after end of prostate biopsy procedure. 2b.prior to IMP administration, at 5-10 minutes after IMP administration and at 10, 30, 60, 90, 120 and 240 minutes after end of prostate biopsy procedure. 3. immediately after end of prostate biopsy 4. measured at 10, 30, 60, 90 and 240 minutes after end of prostate biopsy procedure 5.90 minutes after end of prostate biops | — |
Countries
Czech Republic, Denmark, Finland, Spain
Contacts
Public ContactDirector, Regulatory Affairs
Orexo AB
Outcome results
None listed