A study to learn about the effect of alfentanil for pain relief in patients undergoing prostate biopsy

• Conditions: Pain associated with prostate biopsy.; MedDRA version: 14.1Level: PTClassification code 10004857Term: Biopsy prostateSystem Organ Class: 10022891 - Investigations; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2011-001903-10-DK
• Lead Sponsor: Orexo AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-09
• Last Update Posted: 5 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 200

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified