Symptoms and General Pathology

All Conditions

Nervous System Diseases

Pain

Breakthrough Pain

Neurologic Manifestations

Analgesics

All Drugs and Chemicals

Central Nervous System Depressants

Ketamine

Anesthetics

Anesthetics, Dissociative

Anesthetics, Intravenous

Anesthetics, General

Excitatory Amino Acid Antagonists

Neurotransmitter Agents

PMI-150 (intranasal ketamine)

placebo

Zahid Bajwa, MD

To assess the safety and efficacy of PMI-150 (Intranasal Ketamine) as an analgesic for the treatment of breakthrough pain in cancer patients.

The primary objective is to evaluate the safety and efficacy following the administration of intranasal ketamine in providing pain relief as compared to placebo.

Safety and Efficacy of PMI-150 (Intranasal Ketamine) for the Treatment of Breakthrough Pain in Cancer Patients

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Comparing the Efficacy and Safety of PMI-150 (Intranasal Ketamine) to Placebo as an Analgesic for the Treatment of Breakthrough Pain in Cancer Patients

Hospira, now a wholly owned subsidiary of Pfizer

Cancer Pain

Adjuvants, Anesthesia

Anticoagulants

Other Dietary Supplements

Fentanyl

Analgesics, Opioid

Citric Acid

Sodium Citrate

Narcotics

Citrate

All patients take NasalFent at effective dose to treat up to four episodes of breakthrough cancer pain per day

treatment of up to 4 episodes of pain per day

Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)

Russell K Portenoy, MD

Cancer patients taking regular medication for their pain often still have episodes of severe pain that 'break through' despite their background pain treatment. Fentanyl is a strong, short-acting pain killer often used to treat this 'breakthrough' pain. Nasalfent contains fentanyl in a patented drug delivery system called PecSys and is given via a simple nasal spray. This study will examine the long-term safety of Nasalfent in the treatment of breakthrough cancer pain.

Current treatments for breakthrough cancer pain (BTCP) work too slowly to meet the fast onset of most BTCP episodes, they continue to act longer than the episode of pain lasts and so can have unwanted side effects due to this 'over treatment' of the pain episode. In addition most cancer patients have oral problems which make taking pain relief medication by mouth uncomfortable for the patient. Nasalfent is administered via the nose as a simple spray and can be taken by patients or given by their carers. The nasal route is a common way to administer medication for example in the treatment of migraine or allergy. At any time during the study the patient may take their regular treatment for BTCP should they so wish.

This study will examine the long-term safety of Nasalfent treatment for breakthrough cancer pain.

After the study is completed, patients may continue to take medication if their doctor feels it is in the patient's best interest to do so. Safety information will continue to be collected during this period. Treatment may continue on study for as long as the patient requires treatment or until Nasalfent becomes commercially available.

Long Term Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain

An Open-Label Study Investigating Long-Term Safety and Tolerability of Fentanyl Citrate Nasal Spray in the Treatment of BTCP in Subjects Taking Regular Opioid Therapy

Archimedes Development Ltd

Morphine

Immediate Release Morphine sulphate capsules taken at start of relevant BTCP episode. Each episode treated with either this medication OR the experimental comparator.

Nasalfent spray taken at start of relevant BTCP episode. Each episode to be treated with either this medication OR the active comparator (IRMS)

nasal spray, 100, 200, 400 or 800 mcg dosage according to need, to treat up to four episodes of BTCP per day

Fentanyl citrate

drug dose as required by patient taken to treat up to four epsiodes of BTCP per day

Immediate release morphine sulphate

Marie Fallon

Cancer patients taking regular medication for their pain often still have episodes of severe pain that 'break through' despite their background pain treatment. Fentanyl is a strong, short-acting painkiller often used to treat this 'breakthrough' pain. Nasalfent contains fentanyl in a patented drug delivery system called PecSys and is given via a simple nasal spray. This study will test the efficacy and safety of Nasalfent compared to Immediate Release Morphine Sulphate in the treatment of breakthrough cancer pain.

Current treatments for breakthrough cancer pain (BTCP)work too slowly to meet the fast onset of most BTCP episodes, they continue to act longer than the episode of pain lasts and so can have unwanted side effects due to this 'over treatment' of the pain episode. In addition many cancer patients have oral problems which make taking pain relief medication by mouth uncomfortable for the patient. Nasalfent is administered via the nose as a simple spray and can be taken by patients or given by their carers. The nasal route is a common way to administer medication for example in the treatment of migraine or allergy. At any time during the study the patient may take their regular treatment for BTCP should they so wish.

This study will compare the time of onset and degree of pain relief of Nasalfent to that of Immediate Release Morphine Sulphate. The safety of the two treatment options will also be examined.

Efficacy and Safety Study of Nasalfent for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids

A Multicentre, Double-Blind, Double-Dummy, Two-Phase Crossover Study of Fentanyl Citrate Nasal Spray Compared to Immediate Release Morphine Sulphate in the Treatment of BTCP in Subjects Taking Regular Opioid Therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of PMI-150 (Intranasal Ketamine) for the Treatment of Breakthrough Pain in Cancer Patients	NCT00492388	Pain Cancer	PMI-150 (intran... placebo	18 Years -	Hospira, now a wholly owned subsidiary of Pfizer
Long Term Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain	NCT00458510	Cancers, Pain	Fentanyl (Nasal...	18 Years -	Archimedes Development Ltd
Efficacy and Safety Study of Nasalfent for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids	NCT00589823	Cancers, Pain	Fentanyl citrat... Immediate relea...	18 Years -	Archimedes Development Ltd
Efficacy and Safety Study of Nasalfent for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids	NCT00589823	Cancers, Pain	Fentanyl citrat... Immediate relea...	18 Years -	Archimedes Development Ltd

Spots Global Cancer Trial Database for breakthrough

Every month we try and update this database with for breakthrough cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.