Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT01756651
Eligibility Criteria:
Inclusion Criteria:
1\. Male adult patients scheduled for cystoscopy; additional procedures (e.g. ureteral stent placement, stent exchange, bladder biopsy, retrograde pyelogram) may be included.
Exclusion Criteria:
1. History of analgesic abuse or opioid tolerance
2. Allergy to fentanyl or to any of the components of Lazanda®
3. Acute/chronic nasal problems such as rhinitis or sinusitis
4. Acute bronchial asthma / upper airway obstruction
5. Presence of bradycardia or history of seizures
6. Concomitant use of drugs that inhibit cytochrome P450 isoenzyme 3A4 (e.g., ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, monoamine oxidase inhibitors and verapamil) or exposure to these drugs 30 days prior to placement on the study.
7. Concomitant use of vasoconstrictive nasal decongestants (e.g., oxymetazoline, phenylephrine, xylometazoline)
8. Numeric Rating Scale (NRS) pain score more than 0 at baseline
9. Any situation or condition which, in the investigator's opinion, puts the subject at significant risk, or could confound the study results.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01756651
Study Brief:
Protocol Section:
NCT01756651