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NCT01698645 Clinical Trial

Patient Satisfaction and Quality of Life Impact - PecFent®

Breakthrough Cancer Pain Clinical Trial

— Qualipec  

Official title:
A Spanish , Multicentre, Open-label, Observational Study to Assess Quality of Life and Satisfaction in Subjects Taking PecFent® for the Treatment of Breakthrough Cancer Pain (BTPc)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01698645
Other study ID # CP070/12
Secondary ID
Status Recruiting
Phase N/A
First received October 1, 2012
Last updated July 10, 2013
Start date September 2012

Study information
Verified date July 2013
Source Archimedes Development Ltd
Contact Yolanda Riesgo, MD
Phone + 34 913510373
Email yolandariesgo@archimedespharma.com
Is FDA regulated No
Health authority Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study type Observational

Clinical Trial Summary

National multicenter, prospective, observational study in cancer patients with chronic background pain and breakthrough pain to whom PecFent® has been prescribed under pragmatic condition by a specialist in the treatment of cancer pain conditions.

• Study objectives include assessment of early treatment satisfaction.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult (aged =18 years) with cancer

- Taking at least 60 mg of oral morphine sulfate or equivalent per day for chronic background pain

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• PecFent® (fentanyl) nasal spray

Locations
Country Name City State
Spain Hospital 12 de Octubre Madrid

Sponsors (1)
Lead Sponsor Collaborator
Archimedes Development Ltd

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Satisfaction Satisfaction will be assessed using a 4-point Likert scale. Satisfaction will be assessed approximately 1 hour after each breakthrough pain (BTPc) episode treated with PecFent® from completion of titration through Day 7 No
See also
  Status Clinical Trial Phase
Completed NCT01946555 - Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain N/A
Recruiting NCT01693328 - Patient Satisfaction and Quality of Life Impact - PecFent® N/A
Completed NCT01936636 - Observational Registry Study of Quality of Life When Treating BTcP With Abstral N/A
Completed NCT03669263 - A Dose Titration Study of Fentanyl Buccal Soluble Film for Breakthrough Cancer Pain in Taiwan N/A
Completed NCT02899884 - Characterisation and Epidemiology of Breakthrough Cancer Pain in Spain
Recruiting NCT03564548 - Inhaled Cannabinoids Versus Immediate-release Oral Opioids for the Management of Breakthrough Cancer Pain Phase 2
Not yet recruiting NCT04713189 - Effectiveness and Tolerance of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With Breakthrough Cancer Pain Phase 1/Phase 2
Completed NCT03895762 - Observational Study of Efficacy, Safety and Tolerability of Fentanyl in Korean Cancer Patients
Terminated NCT01439919 - A Clinical Trial to Assess the Clinical Benefit of SSR411298 as Adjunctive Treatment for Persistent Cancer Pain Phase 2
Completed NCT01045603 - Instanyl® Non-Interventional Study N/A
Recruiting NCT00822614 - Safety of Fentanyl TAIFUN Treatment Phase 3
Terminated NCT04468490 - Treatment of Breakthrough Cancer Pain According to European Guidelines