Nasal Fentanyl for Patient Controlled Treatment of Pain i... | NCT01248611

Studies
Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer

NCT01248611

Sponsor

St. Olavs Hospital

Status

Completed

Last Update Posted

May 12, 2014Estimated

Enrollment

10Actual

Phase

Phase 1Phase 2

Conditions

Chronic Pain
Cancer

Interventions

fentanyl

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

May 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Nov 18, 2010

First Submission Date that Met QC Criteria

Nov 24, 2010

First Posted Date

Nov 25, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2014

Last Update Posted Date

May 12, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Traditionally cancer pain is treated with long acting opioids such as morphine around the clock. However, there is no evidence that all patients have a stable pain requiring around the clock medication. So far opioids for self-administration with a rapid onset of action have not been available. Recently a nasal formulation of fentanyl (an opioid similar to morphine) was released in Europe for treatment of breakthrough pain, i.e. an unpredictable pain with short duration that breaks through the otherwise stable pain controlled with the around the clock medication. The basic idea is that this formulation may open for patient controlled analgesia of chronic cancer pain, due to the ultra rapid onset of action of nasally delivered fentanyl. This means that the patient only takes medication when in pain. This single center feasibility / safety study is the first part of a study to investigate this alternative cancer pain treatment approach.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fentanyl	Experimental	cancer patients with pain	Drug: fentanyl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fentanyl	Drug	nasally, dose titrated to effect	fentanyl	Instanyl (nNcomed Pharma)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sedation/drowsiness	scores on a 0-10 numerical rating scale; 0=none / 10=intolerable	10 days
nausea and vomiting	nausea scores on a 0-10 numerical rating scale; 0=none / 10=intolerable vomiting yes/no	10 days

Secondary Outcomes

Measure	Description	Time Frame
pain intensity	scores on a 0-10 numerical rating scale; 0=none / 10=intolerable	10 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cancer patients with metastatic disease
Adult (older than 18 years)
Life expectancy of > 3 months
Cancer-related pain > 3 on an 11 point Numerical Rating Scale (NRS)
In the need of opioids (step II or III)
Able to use nasal drugs.
Women of child bearing potential using adequate contraception
Informed consent given according to applicable requirements before any trial-related activities. Trial-related activities are any procedure that would not have been performed during the routine management of the patient

Exclusion Criteria:

History of substance abuse
Cognitive impairment which makes the patient unable to complete questionnaires or not able to comply with the study procedures
Treated with MAO inhibitor within the last 14 days
Known hypersensitivity to study drug or specific contraindications to the study drug
Nasopharyngeal device such as gastric tube
Concomitant participation in any other trials dealing with pain with an investigational drug or device apart from cancer treatment within 14 days prior to inclusion in this trial
Pathological conditions of the nasal cavity as contraindication to nasal fentanyl
Sleep apnoea syndrome
Pregnant or breastfeeding women
Psychiatric disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Stein Kaasa, MD. PhD	St.Olav's Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
St.Olavs University Hospital		Trondheim		7006	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24604566	Result	Thronaes M, Kaasa S, Dale O. A pilot study of nasal fentanyl for patient controlled treatment of cancer pain. J Opioid Manag. 2014 Jan-Feb;10(1):21-8. doi: 10.5055/jom.2014.0188.

ID	Term
D059350	Chronic Pain
D009369	Neoplasms
D010146	Pain

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds