Know Cancer

forgot password

Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer An Open Label Prospective Phase I b Study

Phase 1/Phase 2
18 Years
Not Enrolling
Chronic Pain, Cancer

Thank you

Trial Information

Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer An Open Label Prospective Phase I b Study

Inclusion Criteria:

1. Cancer patients with metastatic disease

2. Adult (older than 18 years)

3. Life expectancy of > 3 months

4. Cancer-related pain > 3 on an 11 point Numerical Rating Scale (NRS)

5. In the need of opioids (step II or III)

6. Able to use nasal drugs.

7. Women of child bearing potential using adequate contraception

8. 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:

1. History of substance abuse

2. Cognitive impairment which makes the patient unable to complete questionnaires or not
able to comply with the study procedures

3. Treated with MAO inhibitor within the last 14 days

4. Known hypersensitivity to study drug or specific contraindications to the study drug

5. Nasopharyngeal device such as gastric tube

6. 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

7. Pathological conditions of the nasal cavity as contraindication to nasal fentanyl

8. Sleep apnoea syndrome

9. Pregnant or breastfeeding women

10. Psychiatric disease

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

scores on a 0-10 numerical rating scale; 0=none / 10=intolerable

Outcome Time Frame:

10 days

Safety Issue:


Principal Investigator

Stein Kaasa, MD. PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St.Olav's Hospital


Norway: Norwegian Medicines Agency

Study ID:




Start Date:

January 2011

Completion Date:

September 2011

Related Keywords:

  • Chronic Pain
  • Cancer
  • pain
  • adverse effects
  • safety
  • feasibility