Other Acute PainPhase 1NCT01756651

Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures

A Phase 1 study testing Fentanyl pectin in people with Other Acute Pain and Pain Experienced During Cystoscopy, run by Richard C Reznichek, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Other Acute Pain, Pain Experienced During Cystoscopy
What is being tested?: Fentanyl pectin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Feb 2013to 10 May 2016
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Urology Clinic, Harbor-UCLA Medical Center
Torrance, California, 90502

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

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.

Conditions: Other Acute Pain, Pain Experienced During Cystoscopy
Being tested: Fentanyl pectin
Keywords: Intranasal fentanyl, Cystoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fentanyl pectinDrug
Also called Lazanda, Fentanyl
comparison of Intranasal fentanyl 100mcg vs 200 mcg.

Study groups in NCT01756651
Study group	Role	What they receive
Intranasal Fentanyl 100mcg	Experimental	fentanyl pectin nasal spray 100mcg Receives: Drug: Fentanyl pectin
Intranasal Fentanyl 200mcg	Experimental	fentanyl pectin nasal spray 200mcg Receives: Drug: Fentanyl pectin

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: within 3 hours post administration of the drug

Secondary outcomes (1)

Oxyhemoglobin saturation
Pulse oximetry will be recorded at baseline and every 5 minutes for 3 hours post drug-administration.
Measured: Every 5 minutes post administration of the drug until 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 201310 May 2016

First posted27 Dec 2012 (estimated)
Study startFeb 2013
Primary completion10 May 2016
Study completion10 May 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for Other Acute PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01756651
Sponsor's protocol ID: 20812-01
Status last verified: May 2017
First submitted: 20 Dec 2012
Last updated: 11 May 2017
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 18206920
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.
PubMed 16679829
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.
PubMed 17499771
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.
PubMed 17415555
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.
PubMed 16698351
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.
PubMed 1642347
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.
PubMed 8214490
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.
PubMed 8695078
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.
PubMed 8780279
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.
PubMed 18415433
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.
PubMed 10764171
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.
PubMed 21175512
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.
PubMed 17067720
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.
PubMed 16005154
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.
PubMed 18728103

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01756651
Acronym / sponsor ID: 20812-01
Conditions: Other Acute Pain, Pain Experienced During Cystoscopy
Keywords: Intranasal fentanyl, Cystoscopy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Richard C Reznichek, MDUniversity, hospital or other
Collaborators: Depomed
Study start: Feb 2013 (actual)
Primary completion: 10 May 2016 (actual)
Study completion: 10 May 2016 (actual)
First posted: 27 Dec 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Intranasal Fentanyl 100mcg	Experimental	Drug: Fentanyl pectinfentanyl pectin nasal spray 100mcg
Intranasal Fentanyl 200mcg	Experimental	Drug: Fentanyl pectinfentanyl pectin nasal spray 200mcg

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fentanyl pectinAlso: Lazanda, Fentanylcomparison of Intranasal fentanyl 100mcg vs 200 mcg.	Drug	Intranasal Fentanyl 100mcg, Intranasal Fentanyl 200mcg

Primary outcome

Change from baseline in pain numeric rating scale
Time frame: within 3 hours post administration of the drug
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).

1 secondary outcome

Oxyhemoglobin saturation
Time frame: Every 5 minutes post administration of the drug until 3 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
Background: PubMed 18206920Patel 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.
Background: PubMed 16679829Taghizadeh 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.
Background: PubMed 17499771Calleary 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.
Background: PubMed 17415555Song 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.
Background: PubMed 16698351Hruby 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.
Background: PubMed 1642347Striebel 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.
Background: PubMed 8214490Striebel 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.
Background: PubMed 8695078Striebel 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.
Background: PubMed 8780279Striebel 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.
Background: PubMed 18415433Striebel 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.
Background: PubMed 10764171Toussaint 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.
Background: PubMed 21175512Saunders 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard Reznichek, MD principal investigator

University of California, Los Angeles

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fentanyl pectin in people with Other Acute Pain and Pain Experienced During Cystoscopy, run by Richard C Reznichek, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in pain numeric rating scale (time frame: within 3 hours post administration of the drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01756651, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.