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Completed

NCT Number: NCT01842893

Efficacy and Safety of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer

The purpose of the study is to assess the clinical effectiveness of Fentanyl ETHYPHARM when used to relieve breakthrough pain (BTP) in opioid-treated cancer patients.

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Key information

Conditions

Breakthrough Pain Cancer Neoplasms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pain Care Units

Prague, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent
  • Malignant solid tumor or a hematological malignancy causing cancer-related pain
  • Background opioid treatment at a stable dose for at least a week
  • One to four episodes of breakthrough pain per day

Main exclusion criteria:

  • Hypersensitivity to fentanyl or to any of the excipients
  • Intrathecal opioids
  • Recent history of substance abuse
  • Recent or planned therapy that would alter pain
  • Moderate or severe hepatic or renal disease

Treatment and study plan

Fentanyl Ethypharm

Drug

After an open-label titration to identify an optimal dose, patients were randomized to 1 of 13 prespecified sequences of 9 tablets (6 fentanyl and 3 placebo)

Primary outcomes

  1. Summed Pain Intensity Difference at 30 minutes (SPID30).

    Time frame: 30 minutes post dose

Secondary outcomes

  1. SPID at 3, 6, 10, 15 and 60 minutes post-dosing

    Time frame: 3, 6, 10, 15 and 60 minutes post-dosing

  2. SPID at 15 and 30 minutes according to the pathophysiology of the pain (neuropathic, nociceptive)

    Time frame: 15 and 30 minutes post dose

  3. Pain Intensity Difference at 3, 6, 10, 15, 30 and 60 minutes after dosing

    Time frame: 3, 6, 10, 15, 30 and 60 minutes after dosing

  4. Pain Relief at 3, 6, 10, 15, 30 and 60 minutes after dosing

    Time frame: 3, 6, 10, 15, 30 and 60 minutes after dosing

  5. The proportion of episodes of BTP that required rescue medication

    Time frame: 15 and 30 minutes post dose

  6. the proportion of episodes with more than 33% and 50% of improvement in Pain Intensity scores

    Time frame: 15 and 30 minutes post dose

  7. Recording of safety data

    Time frame: During all the study duration, an expected average of 8 weeks

    Adverse events, vital signs, urinary pregnancy test

Sponsors and collaborators

Lead sponsor

Ethypharm

Industry

Registry information

Official study title

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

Acronym: ETHYFYL

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 30, 2013
Registry last updated
May 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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