Ignite Creation Date:
2024-05-06 @ 2:11 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01980498
Status:
WITHDRAWN
Last Update Posted:
2015-10-07
First Post:
2013-10-21
Brief Title:
PEctin Rapid Fentanyl Efficacy Clinical Trial For pAin at Swallowing Undergoing radioTherapy
Sponsor:
LMolteni C dei Flli Alitti-Soc di Esercizio SpA
Organization:
LMolteni C dei Flli Alitti-Soc di Esercizio SpA
Study Overview
Official Title:
Multicenter Randomized Open Trial to Evaluate Efficacy of Fentanyl Pectin Nasal Spray vs Physician Choice-Usual Care in Reducing Predictable Breakthrough Pain at Swallowing in HeadNeck Cancer Patients Undergoing Radiotherapy
Status:
WITHDRAWN
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERFECT FAST
Brief Summary:
The primary objective of the present phase IIIb study is to assess the efficacy of FPNS compared with Physician Choice-Usual Care PC-UC in the reduction of swallowing predictable BTP in head and neck cancer patients undergoing radiotherapy with or without chemotherapy
Detailed Description:
Population In and out patients with head and neck cancer undergoing radiotherapy regardless of the day of the radiotherapy treatment with or without chemotherapy and taking at least 60 mg of oral morphine daily or an equianalgesic dose of another opioid to control background pain background pain controlled is defined as NRS 4 but with uncontrolled pain at swallowing moderatesevere intensity 4 on a NRS 0-10
Study design Patients that have signed the ICF and met inclusion and exclusion criteria are randomly assigned 11 to receive one of the following predictable BTP at swallowing treatments
1 Fentanyl pectin nasal spray FPNS
2 Physician choice-Usual Care PC-UC Each patient will take the drug no more than 3 episode a day at main meals breakfast lunch and dinner for 15 episodes in total in 6 -1 2 consecutive days At each episode the patients will record the pain at baseline before drug administration and 10 20 30 minutes after taking FPNS or PC-UC
At each meal if the administered dose of FPNS or PC-UC is not adequately effective on pain control the patient is allowed to take a rescue medication of IRMS after 30 min from FPNS or PC-UC administration
Study design Patients that have signed the ICF and met inclusion and exclusion criteria are randomly assigned 11 to receive one of the following predictable BTP at swallowing treatments
1 Fentanyl pectin nasal spray FPNS
2 Physician choice-Usual Care PC-UC Each patient will take the drug no more than 3 episode a day at main meals breakfast lunch and dinner for 15 episodes in total in 6 -1 2 consecutive days At each episode the patients will record the pain at baseline before drug administration and 10 20 30 minutes after taking FPNS or PC-UC
At each meal if the administered dose of FPNS or PC-UC is not adequately effective on pain control the patient is allowed to take a rescue medication of IRMS after 30 min from FPNS or PC-UC administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-001271-20 | EUDRACT_NUMBER | None | None |