Nasal Fentanyl for Chronic Cancer Pain (NFCP-2)
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|ClinicalTrials.gov Identifier: NCT01906073|
Recruitment Status : Recruiting
First Posted : July 23, 2013
Last Update Posted : January 27, 2020
Today, patients with cancer pain in need of opioids for moderate to severe pain get long-acting morphine twice a day and morphine tablets taken on demand in addition. This procedure might be based on the assumption that cancer pain is persistent, although the evidence to support whether this assumption applies to all cancer patients is lacking. Some cancer patients might not need a fixed dose of long-acting morphine.
Because of rapid pain relief, the new fentanyl drugs open for the possibility to take an opioid on demand when pain occurs.
A pilot study where 10 patients with cancer pain were treated with a rapid-acting fentanyl nasal spray taken on demand, showed that this treatment was apparently feasible and safe for these patients.
This approach is studied further in NFCP-II. The participants will be treated with rapid-acting fentanyl nasal spray and long-acting morphine in a crossover study. The primary outcome will be patient satisfaction.
The study will consist of a test dose of nasal fentanyl, a dose-finding phase and a treatment phase with either nasal fentanyl taken on demand or slow-released morphine taken twice a day. After 10 days of treatment there is a crossover and the opposite drug is used for the same participant. Morphine tablets can be taken on demand in all phases of the study.
The participants will meet the investigator at inclusion, at the crossover and at the end of treatment. During the study, a diary is filled in by the participants every morning. Questions about pain and side effects are answered. Satisfaction is measured at the crossover and at end of treatment while preference is measured at the end of treatment.
|Condition or disease||Intervention/treatment||Phase|
|Cancer Pain||Drug: intranasal fentanyl spray Drug: slow release morphine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Cross-over, Randomized Controlled Multicenter Phase III Study Comparing Standard Oral SR-morphine by the Clock Medications With Self-controlled Nasal Fentanyl for Chronic Cancer Pain Requiring Opioids|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: intranasal fentanyl spray
Fentanyl for nasal administration (NF), is supplied as sprays containing a phosphate buffered solution of fentanyl citrate. NF is available in three strengths: 0.5 mg/ml, 1 mg/ml and 2 mg/ml in multiple-dose sprays. The corresponding doses are 50, 100 and 200 µg/puff. NF is applied as one puff in one nostril. One puff defines and equals one dose. Applying a puff to each nostril the upper dose can be increased to 400 µg. The doses used in this study are 50, 100, 200 ad 400µg. Fentanyl may be administered for up to 6 pain episodes/ 24 hours. For each pain episode, a dose of NF is self-administrated in one nostril. If pain relief is not achieved, another dose of NF could be administered in the opposite nostril after 15 minutes.
Drug: intranasal fentanyl spray
Other Name: Instanyl
Active Comparator: slow release morphine
The active substance is released gradually during its transit through the gastrointestinal tract. Slow release (SR) morphine is available in 5, 10, 30, 60, 100 and 200 mg. SR morphine is administered twice a day, usually every twelfth hour.
Drug: slow release morphine
Other Name: Morphine sulphate pentahydrate
- the difference in patient reported satisfaction between the two treatment sessions [ Time Frame: 13 days ]measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
- Patient preference (overall; including pain relief, tolerance to adverse effects and convenience) of treatments after finishing the second part of the clinical study [ Time Frame: 26 days ]5 point Likert scale
- Overall rating of average pain control in the two treatment phases [ Time Frame: 26 days ]measured by an 11- point numeric rating scale
- Overall rating of average side effects in the two treatment phase [ Time Frame: 26 days ]measured by an 11-point numeric rate scales
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01906073
|Contact: Morten Thronæs, MDemail@example.com|
|Contact: Ola Dale, MD firstname.lastname@example.org|
|Contact: David Currow, MD PhD|
|Contact: Lukas Radbruch, MD PhD|
|Fondazione IRCCS Istituto Nazionale dei Tumori||Recruiting|
|Contact: Augusto Caraceni, MD PhD|
|Maastricht University Medical Centre||Recruiting|
|Contact: Annemie Schols, MD PhD|
|St Olavs Hospital||Recruiting|
|Contact: Morten Thronæs, MD email@example.com|
|Contact: Ola Dale, MD prof firstname.lastname@example.org|
|L'Hospitalet de Llobregat||Recruiting|
|Contact: Josep Porta Sales, MD PhD|
|Kantonsspital St. Gallen||Recruiting|
|St Gallen, Switzerland|
|Contact: Florian Strasser, MD PhD|
|Study Director:||Stein Kaasa, MD prof||Norwegian University of Science and Technology|