Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures

NCT01756651 | Completed Phase 1 DMC

• 1 other identifier: 20812-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and efficacy of intranasally-administrated fentanyl pectin spray (Lazanda®)given to decrease the pain during cystoscopy (the passage of a telescopic instrument into the bladder for purpose of diagnosing the cause of blood in the urine, urinary complaints or any other problems with the urinary bladder). The current standard practice is to use Lidocaine jelly (a local anesthetic) given through the urethra to lubricate and decrease local pain. In this study, an additional medicine (Lazanda®) is used to reduce pain that occurs during and after the above procedure.

Conditions

Other Acute Pain; Pain Experienced During Cystoscopy

Keywords

Intranasal fentanyl; Cystoscopy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in pain numeric rating scale

  The primary endpoint is the worst pain experienced at any time during the procedure. Pain will be assessed using the Numeric Rating Scale (NRS score 0 = no pain to 10 = worst possible pain).

  within 3 hours post administration of the drug

Secondary Outcomes (1)

• Oxyhemoglobin saturation

  Every 5 minutes post administration of the drug until 3 hours

Other Outcomes (1)

• Mean arterial blood pressure

  every 15 minutes until 3 hours post drug-administration

Study Arms (2)

Intranasal Fentanyl 100mcg

EXPERIMENTAL

fentanyl pectin nasal spray 100mcg

Drug: Fentanyl pectin

Intranasal Fentanyl 200mcg

EXPERIMENTAL

fentanyl pectin nasal spray 200mcg

Drug: Fentanyl pectin

Interventions

Fentanyl pectin DRUG

comparison of Intranasal fentanyl 100mcg vs 200 mcg.

Also known as: Lazanda, Fentanyl

Intranasal Fentanyl 100mcg; Intranasal Fentanyl 200mcg

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male adult patients scheduled for cystoscopy; additional procedures (e.g. ureteral stent placement, stent exchange, bladder biopsy, retrograde pyelogram) may be included.

You may not qualify if:

• History of analgesic abuse or opioid tolerance
• Allergy to fentanyl or to any of the components of Lazanda®
• Acute/chronic nasal problems such as rhinitis or sinusitis
• Acute bronchial asthma / upper airway obstruction
• Presence of bradycardia or history of seizures
• 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.
• Concomitant use of vasoconstrictive nasal decongestants (e.g., oxymetazoline, phenylephrine, xylometazoline)
• Numeric Rating Scale (NRS) pain score more than 0 at baseline
• Any situation or condition which, in the investigator's opinion, puts the subject at significant risk, or could confound the study results.

Sponsors & Collaborators

• Richard C Reznichek, MD: lead
• Depomed: collaborator

Study Sites (1)

Urology Clinic, Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Related Publications (29)

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MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Richard Reznichek, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 27, 2012
• Study Start: February 1, 2013
• Primary Completion: May 10, 2016
• Study Completion: May 10, 2016
• Last Updated: May 11, 2017

Record last verified: 2017-05

Locations

US (1)