Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2026-02-01 @ 4:05 PM
Study NCT ID:
NCT01756651
Status:
COMPLETED
Last Update Posted:
2017-05-11
First Post:
2012-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-10', 'studyFirstSubmitDate': '2012-12-20', 'studyFirstSubmitQcDate': '2012-12-20', 'lastUpdatePostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean arterial blood pressure', 'timeFrame': 'every 15 minutes until 3 hours post drug-administration', 'description': 'Will be recorded at baseline and every 15 minutes for 3 hours post drug-administration.'}], 'primaryOutcomes': [{'measure': 'Change from baseline in pain numeric rating scale', 'timeFrame': 'within 3 hours post administration of the drug', 'description': 'The primary endpoint is the worst pain experienced at any time during the procedure.\n\nPain will be assessed using the Numeric Rating Scale (NRS score 0 = no pain to 10 = worst possible pain).'}], 'secondaryOutcomes': [{'measure': 'Oxyhemoglobin saturation', 'timeFrame': 'Every 5 minutes post administration of the drug until 3 hours', 'description': 'Pulse oximetry will be recorded at baseline and every 5 minutes for 3 hours post drug-administration.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intranasal fentanyl', 'Cystoscopy'], 'conditions': ['Other Acute Pain', 'Pain Experienced During Cystoscopy']}, 'referencesModule': {'references': [{'pmid': '18206920', 'type': 'BACKGROUND', 'citation': 'Patel AR, Jones JS, Babineau D. Lidocaine 2% gel versus plain lubricating gel for pain reduction during flexible cystoscopy: a meta-analysis of prospective, randomized, controlled trials. J Urol. 2008 Mar;179(3):986-90. doi: 10.1016/j.juro.2007.10.065. Epub 2008 Jan 18.'}, {'pmid': '16679829', 'type': 'BACKGROUND', 'citation': 'Taghizadeh AK, El Madani A, Gard PR, Li CY, Thomas PJ, Denyer SP. When does it hurt? Pain during flexible cystoscopy in men. Urol Int. 2006;76(4):301-3. doi: 10.1159/000092051.'}, {'pmid': '17499771', 'type': 'BACKGROUND', 'citation': 'Calleary JG, Masood J, Van-Mallaerts R, Barua JM. Nitrous oxide inhalation to improve patient acceptance and reduce procedure related pain of flexible cystoscopy for men younger than 55 years. J Urol. 2007 Jul;178(1):184-8; discussion 188. doi: 10.1016/j.juro.2007.03.036. Epub 2007 May 17.'}, {'pmid': '17415555', 'type': 'BACKGROUND', 'citation': 'Song YS, Song ES, Kim KJ, Park YH, Ku JH. Midazolam anesthesia during rigid and flexible cystoscopy. Urol Res. 2007 Jun;35(3):139-42. doi: 10.1007/s00240-007-0091-7. Epub 2007 Apr 6.'}, {'pmid': '16698351', 'type': 'BACKGROUND', 'citation': 'Hruby G, Ames C, Chen C, Yan Y, Sagar J, Baron P, Landman J. Assessment of efficacy of transcutaneous electrical nerve stimulation for pain management during office-based flexible cystoscopy. Urology. 2006 May;67(5):914-7. doi: 10.1016/j.urology.2005.11.043.'}, {'pmid': '1642347', 'type': 'BACKGROUND', 'citation': 'Striebel HW, Koenigs D, Kramer J. Postoperative pain management by intranasal demand-adapted fentanyl titration. Anesthesiology. 1992 Aug;77(2):281-5. doi: 10.1097/00000542-199208000-00010.'}, {'pmid': '8214490', 'type': 'BACKGROUND', 'citation': 'Striebel HW, Pommerening J, Rieger A. Intranasal fentanyl titration for postoperative pain management in an unselected population. Anaesthesia. 1993 Sep;48(9):753-7. doi: 10.1111/j.1365-2044.1993.tb07583.x.'}, {'pmid': '8695078', 'type': 'BACKGROUND', 'citation': 'Striebel HW, Olmann T, Spies C, Brummer G. Patient-controlled intranasal analgesia (PCINA) for the management of postoperative pain: a pilot study. J Clin Anesth. 1996 Feb;8(1):4-8. doi: 10.1016/0952-8180(95)00167-0.'}, {'pmid': '8780279', 'type': 'BACKGROUND', 'citation': 'Striebel HW, Oelmann T, Spies C, Rieger A, Schwagmeier R. Patient-controlled intranasal analgesia: a method for noninvasive postoperative pain management. Anesth Analg. 1996 Sep;83(3):548-51. doi: 10.1097/00000539-199609000-00019.'}, {'pmid': '18415433', 'type': 'BACKGROUND', 'citation': 'Striebel HW, Kramer J, Luhmann I, Rohierse-Hohler I, Rieger A. [Pharmacokinetics of intranasal Fentanyl.]. Schmerz. 1993 Jun;7(2):122-5. doi: 10.1007/BF02527870. No abstract available. German.'}, {'pmid': '10764171', 'type': 'BACKGROUND', 'citation': 'Toussaint S, Maidl J, Schwagmeier R, Striebel HW. Patient-controlled intranasal analgesia: effective alternative to intravenous PCA for postoperative pain relief. Can J Anaesth. 2000 Apr;47(4):299-302. doi: 10.1007/BF03020941.'}, {'pmid': '21175512', 'type': 'BACKGROUND', 'citation': 'Saunders M, Adelgais K, Nelson D. Use of intranasal fentanyl for the relief of pediatric orthopedic trauma pain. Acad Emerg Med. 2010 Nov;17(11):1155-61. doi: 10.1111/j.1553-2712.2010.00905.x.'}, {'pmid': '17067720', 'type': 'BACKGROUND', 'citation': "Borland M, Jacobs I, King B, O'Brien D. A randomized controlled trial comparing intranasal fentanyl to intravenous morphine for managing acute pain in children in the emergency department. Ann Emerg Med. 2007 Mar;49(3):335-40. doi: 10.1016/j.annemergmed.2006.06.016. Epub 2006 Oct 25."}, {'pmid': '16005154', 'type': 'BACKGROUND', 'citation': 'Borland ML, Bergesio R, Pascoe EM, Turner S, Woodger S. Intranasal fentanyl is an equivalent analgesic to oral morphine in paediatric burns patients for dressing changes: a randomised double blind crossover study. Burns. 2005 Nov;31(7):831-7. doi: 10.1016/j.burns.2005.05.001. Epub 2005 Jul 6.'}, {'pmid': '18728103', 'type': 'BACKGROUND', 'citation': 'Foster D, Upton R, Christrup L, Popper L. Pharmacokinetics and pharmacodynamics of intranasal versus intravenous fentanyl in patients with pain after oral surgery. Ann Pharmacother. 2008 Oct;42(10):1380-7. doi: 10.1345/aph.1L168. Epub 2008 Aug 26.'}, {'pmid': '18405786', 'type': 'BACKGROUND', 'citation': 'Christrup LL, Foster D, Popper LD, Troen T, Upton R. Pharmacokinetics, efficacy, and tolerability of fentanyl following intranasal versus intravenous administration in adults undergoing third-molar extraction: a randomized, double-blind, double-dummy, two-way, crossover study. Clin Ther. 2008 Mar;30(3):469-81. doi: 10.1016/j.clinthera.2008.03.001.'}, {'pmid': '9565737', 'type': 'BACKGROUND', 'citation': 'Fuhr U. Drug interactions with grapefruit juice. Extent, probable mechanism and clinical relevance. Drug Saf. 1998 Apr;18(4):251-72. doi: 10.2165/00002018-199818040-00002.'}, {'pmid': '8403128', 'type': 'BACKGROUND', 'citation': 'Baele P, Kestens-Servaye Y, Goenen M. MAOI and cardiac surgery. Can J Anaesth. 1993 Jun;40(6):579-80. doi: 10.1007/BF03009749. No abstract available.'}, {'pmid': '16051647', 'type': 'BACKGROUND', 'citation': 'Gillman PK. Monoamine oxidase inhibitors, opioid analgesics and serotonin toxicity. Br J Anaesth. 2005 Oct;95(4):434-41. doi: 10.1093/bja/aei210. Epub 2005 Jul 28.'}, {'pmid': '1464133', 'type': 'BACKGROUND', 'citation': 'Noble WH, Baker A. MAO inhibitors and coronary artery surgery: a patient death. Can J Anaesth. 1992 Dec;39(10):1061-6. doi: 10.1007/BF03008376.'}, {'pmid': '12139528', 'type': 'BACKGROUND', 'citation': 'Dale O, Hjortkjaer R, Kharasch ED. Nasal administration of opioids for pain management in adults. Acta Anaesthesiol Scand. 2002 Aug;46(7):759-70. doi: 10.1034/j.1399-6576.2002.460702.x.'}, {'pmid': '21084042', 'type': 'BACKGROUND', 'citation': 'Fisher A, Watling M, Smith A, Knight A. Pharmacokinetics and relative bioavailability of fentanyl pectin nasal spray 100 - 800 microg in healthy volunteers. Int J Clin Pharmacol Ther. 2010 Dec;48(12):860-7. doi: 10.5414/cpp48860.'}, {'pmid': '22260169', 'type': 'BACKGROUND', 'citation': 'Hansen MS, Mathiesen O, Trautner S, Dahl JB. Intranasal fentanyl in the treatment of acute pain--a systematic review. Acta Anaesthesiol Scand. 2012 Apr;56(4):407-19. doi: 10.1111/j.1399-6576.2011.02613.x. Epub 2012 Jan 19.'}, {'pmid': '20645689', 'type': 'BACKGROUND', 'citation': 'Panagiotou I, Mystakidou K. Intranasal fentanyl: from pharmacokinetics and bioavailability to current treatment applications. Expert Rev Anticancer Ther. 2010 Jul;10(7):1009-21. doi: 10.1586/era.10.77.'}, {'pmid': '21573046', 'type': 'BACKGROUND', 'citation': 'Prommer E, Thompson L. Intranasal fentanyl for pain control: current status with a focus on patient considerations. Patient Prefer Adherence. 2011 Mar 18;5:157-64. doi: 10.2147/PPA.S7665.'}, {'pmid': '19695386', 'type': 'BACKGROUND', 'citation': 'Kress HG, Oronska A, Kaczmarek Z, Kaasa S, Colberg T, Nolte T. Efficacy and tolerability of intranasal fentanyl spray 50 to 200 microg for breakthrough pain in patients with cancer: a phase III, multinational, randomized, double-blind, placebo-controlled, crossover trial with a 10-month, open-label extension treatment period. Clin Ther. 2009 Jun;31(6):1177-91. doi: 10.1016/j.clinthera.2009.05.022.'}, {'pmid': '19792837', 'type': 'BACKGROUND', 'citation': 'Mercadante S, Radbruch L, Davies A, Poulain P, Sitte T, Perkins P, Colberg T, Camba MA. A comparison of intranasal fentanyl spray with oral transmucosal fentanyl citrate for the treatment of breakthrough cancer pain: an open-label, randomised, crossover trial. Curr Med Res Opin. 2009 Nov;25(11):2805-15. doi: 10.1185/03007990903336135.'}, {'pmid': '8590498', 'type': 'BACKGROUND', 'citation': 'Chung F. Discharge criteria--a new trend. Can J Anaesth. 1995 Nov;42(11):1056-8. doi: 10.1007/BF03011083.'}, {'pmid': '12218768', 'type': 'BACKGROUND', 'citation': 'Callahan CM, Unverzagt FW, Hui SL, Perkins AJ, Hendrie HC. Six-item screener to identify cognitive impairment among potential subjects for clinical research. Med Care. 2002 Sep;40(9):771-81. doi: 10.1097/00005650-200209000-00007.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'In this prospective study, twenty subjects will be enrolled. The first ten will receive a dose of 100mcg pectin fentanyl nasal spray (Lazanda®). The second ten will receive a dose of 200mcg pectin fentanyl nasal spray (Lazanda®) if the 100mcg was well tolerated in the first ten. In all cases, Lidocaine jelly is used as an local anesthetic in the urethra.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1\\. Male adult patients scheduled for cystoscopy; additional procedures (e.g. ureteral stent placement, stent exchange, bladder biopsy, retrograde pyelogram) may be included.\n\nExclusion Criteria:\n\n1. History of analgesic abuse or opioid tolerance\n2. Allergy to fentanyl or to any of the components of Lazanda®\n3. Acute/chronic nasal problems such as rhinitis or sinusitis\n4. Acute bronchial asthma / upper airway obstruction\n5. Presence of bradycardia or history of seizures\n6. 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.\n7. Concomitant use of vasoconstrictive nasal decongestants (e.g., oxymetazoline, phenylephrine, xylometazoline)\n8. Numeric Rating Scale (NRS) pain score more than 0 at baseline\n9. Any situation or condition which, in the investigator's opinion, puts the subject at significant risk, or could confound the study results."}, 'identificationModule': {'nctId': 'NCT01756651', 'briefTitle': 'Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center'}, 'officialTitle': 'A Prospective Study Comparing the Efficacy and Safety of 100 mcg and 200 mcg of Intranasal Fentanyl Pectin Spray as an Analgesic in Adult Males Undergoing Outpatient Cystoscopic Procedures', 'orgStudyIdInfo': {'id': '20812-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intranasal Fentanyl 100mcg', 'description': 'fentanyl pectin nasal spray 100mcg', 'interventionNames': ['Drug: Fentanyl pectin']}, {'type': 'EXPERIMENTAL', 'label': 'Intranasal Fentanyl 200mcg', 'description': 'fentanyl pectin nasal spray 200mcg', 'interventionNames': ['Drug: Fentanyl pectin']}], 'interventions': [{'name': 'Fentanyl pectin', 'type': 'DRUG', 'otherNames': ['Lazanda', 'Fentanyl'], 'description': 'comparison of Intranasal fentanyl 100mcg vs 200 mcg.', 'armGroupLabels': ['Intranasal Fentanyl 100mcg', 'Intranasal Fentanyl 200mcg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Urology Clinic, Harbor-UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}], 'overallOfficials': [{'name': 'Richard Reznichek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Richard C Reznichek, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Depomed', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Richard C Reznichek, MD', 'investigatorAffiliation': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center'}}}}