NCT02050503

Brief Summary

An open-label, non-randomized study to assess the titration, safety and efficacy of intranasal fentanyl pectin nasal spray for the treatment of secondary breakthrough pain secondary to radiation-induced mucositis in patients with confirmed tolerance of opioid therapy for chronic pain. Study objectives include assessment of breakthrough pain episodes related with food intake in patients with mucositis secondary to radiotherapy or radio-chemotherapy for head and neck tumors

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

1.5 years

First QC Date

January 29, 2014

Last Update Submit

March 16, 2015

Conditions

Breakthrough PainMucositisRadiotherapyChemotherapyHead and Neck Cancer

Keywords

MucositisBreakthrough painHead Nad neck cancerIntranasal transmucosal fentanyl in pectin

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity Difference

    Pain Intensity difference: Pain Intensity will be measured 30 min after starting food intake during the screening phase and 30 min after intranasal transmucosal fentanyl in pectin administration/food intake during the treatment phase

    30 minutes after PecFent administration

Secondary Outcomes (1)

  • number of episodes of breakthrough pain requiring additional (rescue) analgesic treatment after administration of the study medication

    12 episodes of breakthrough pain presenting within a maximum of 7 days.

Other Outcomes (1)

  • safety of intranasal transmucosal fentanyl

    7 days

Study Arms (1)

intranasal transmucosal fentanyl pectin

intranasal transmucosal fentanyl in pectin (100, 200, 400 or 800 microg) intranasal route titration phase 7 days treatment phase until completing treatment of 12 consecutive episodes of breakthrough pain

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adults of either sex and over 18 and under 75 years of age, receiving continued treatment with long half-life or controlled release opioids, experiencing breakthrough pain secondary to mucositis in the context of radiotherapy or radio-chemotherapy for head and neck tumors.

You may not qualify if:

  • Patients without controlled release opioid treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alejandro de la Torre. Hospital Puerta de Hierro

Majadahonda, Madrid, 28220, Spain

Location

MeSH Terms

Conditions

Breakthrough PainMucositisHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic DiseasesNeoplasms by SiteNeoplasms

Study Officials

  • Alejandro De la Torre, MD

    GICOR & Hospital Puerta de Hierro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2014

First Posted

January 30, 2014

Study Start

December 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

ES(1)