Symptoms and General Pathology

All Conditions

Nervous System Diseases

Rare Diseases

Cancer Pain

Back Pain

Low Back Pain

Pain

Neurologic Manifestations

Chronic Graft Versus Host Disease

Analgesics

All Drugs and Chemicals

Adjuvants, Anesthesia

Central Nervous System Depressants

Oxymorphone

Analgesics, Opioid

Narcotics

Anesthetics

Oxymorphone ER

Sr. Director

The purpose of this study is to evaluate the long-term safety and tolerability of oxymorphone ER as an analgesic in cancer and lower back pain subjects having chronic moderate to severe pain.

Open-Label Extension to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy

An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy of Numorphan® CR (Oxymorphone HCL Controlled Release) in Subjects With Cancer Pain or Chronic Lower Back Pain.

Endo Pharmaceuticals

Sr. Director, Cliniacal R&D

Anticoagulants

Other Dietary Supplements

Fentanyl

Citric Acid

Sodium Citrate

Anesthetics, Intravenous

Anesthetics, General

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

Mark Watling, Group Medical Director

Interventions based on published pain guideline. The interventions consisted of the following: (1) nursing pain assessment of current pain, worst pain, pain relief, and acceptability of pain; (2) feedback to guide analgesic prescribing by physician.

Cancer pain management

Dae Hyun Kim, Prof

The purpose of this study was to prospectively evaluate the effect of cancer pain management protocol on hospitalized cancer patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Open-Label Extension to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy	NCT00904280	Cancers, Pain Lower Back Pain	Oxymorphone ER	18 Years - 75 Years	Endo Pharmaceuticals
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
The Effect of Cancer Pain Management Protocol on Hospitalized Cancer Patients: A Pilot Study	NCT01043068	Cancers, Pain	Cancer pain man...	18 Years -	National Cancer Center, Korea
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

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