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Randomized, Placebo-controlled Study of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Breakthrough Pain, Cancer

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Trial Information

Randomized, Placebo-controlled Study of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer

Inclusion Criteria


Inclusion criteria:

1. Written informed consent

2. Malignant solid tumor or a hematological malignancy causing cancer-related pain

3. Background opioid treatment at a stable dose for at least a week

4. One to four episodes of breakthrough pain per day

Main exclusion criteria:

1. Hypersensitivity to fentanyl or to any of the excipients

2. Intrathecal opioids

3. Recent history of substance abuse

4. Recent or planned therapy that would alter pain

5. Moderate or severe hepatic or renal disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Summed Pain Intensity Difference at 30 minutes (SPID30).

Outcome Time Frame:

30 minutes post dose

Safety Issue:

No

Authority:

Czech Republic: Ethics Committee

Study ID:

FYL/24019/008

NCT ID:

NCT01842893

Start Date:

November 2011

Completion Date:

July 2012

Related Keywords:

  • Breakthrough Pain
  • Cancer
  • fentanyl
  • breakthrough pain
  • opioid treated cancer patients

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