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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT Number 2007-005222-69 |
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| Name | Class |
|---|---|
| Mario Negri Institute for Pharmacological Research | OTHER |
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The aim of the study is to assess tolerability and activity of oxycodone and pregabalin in combination for the treatment of oncological neuropathic pain with two different strategies.
Neuropathic pain is frequently diagnosed as a complication of cancer pain. While opioids are the mainstay of cancer pain management,their efficacy in neuropathic pain seems to be less then optimal,and adjuvant drugs, mainly anticonvulsants and antidepressants,are often combined with opioids in the analgesic regimen of patients with neuropathic cancer pain. This approach is suggested by well-established guidelines, but the analgesic benefit and the safety of pregabalin and oxycodone in combination is not yet documented.
The aim of this study is to assess the activity and tolerability of the addition of pregabalin to oxycodone in the treatment of patients with neuropathic pain due to neoplasm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | oxycodone 20 mg/day plus pregabalin at increasing dose starting from 50 mg/day for 15 days or until unacceptable toxicity develops |
|
| B | Active Comparator | pregabalin 50 mg/day plus oxycodone at increasing dose starting from 20 mg/day. For 15 days or until unacceptable toxicity develops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxycodone | Drug | Arm A - 20 mg/day Arm B - increasing dose startnig at 20 mg/day For 15 days or until unacceptable toxicity develops. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale | within 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain control rate | within 15 days | |
| Reduction of Break Through Pain number | within 15 days | |
| Record of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriella Farina, MD | Fatebenefratelli and Ophtalmic Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Fatebenefratelli | Benevento | Benevento | 82100 | Italy | ||
| Ospedali Riuniti |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Merskey H, Bugduk N. Classification of chronic pain. Description of chronic pain. Description of chronic pain syndromes and definitions of chronic pain terms. Seattle: IASP, press 1994 | ||
| 11981518 | Background | Negri E, Bettaglio R, Demartini L, Allegri M, Barbieri M, Miotti D, Paulin L, Buonocore M, Bonezzi C. [Validation of the Italian version of the "Neuropathic Pain Scale" and its clinical applications]. Minerva Anestesiol. 2002 Mar;68(3):95-104. Italian. | |
| 15952009 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010146 | Pain |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| pregabalin | Drug | Arm A - pregabalin at increasing dose starting from 50 mg/day Arm B - pregabalin 50 mg/day For 15 days or until unacceptable toxicity develops. |
|
| within 15 days |
| Reduction of allodynia in patients presenting it at T0 | within 15 days |
| Patient satisfaction | within 15 days |
| Assessing whether COMT and mu blood polymorphisms are associated to response | within 15 days |
| Bergamo |
| Bergamo |
| 24123 |
| Italy |
| Ospedale S. Orsola | Brescia | Brescia | 25122 | Italy |
| Ospedale Serbelloni | Gorgonzola | Milano | 29964 | Italy |
| Fatebenefratelli and Ophtalmic Hospital | Milan | Milano | 20121 | Italy |
| Ospedale Civile di Legnano | Parabiago | Milano | 20015 | Italy |
| Ospedale Fatebenefratelli | Roma | Roma | Italy |
| Ospedale Sacro Cuore | Negrar | Verona | 37024 | Italy |
| Background |
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| 23577077 | Derived | Garassino MC, Piva S, La Verde N, Spagnoletti I, Iorno V, Carbone C, Febbraro A, Bianchi A, Bramati A, Moretti A, Ganzinelli M, Marabese M, Gentili M, Torri V, Farina G. Randomised phase II trial (NCT00637975) evaluating activity and toxicity of two different escalating strategies for pregabalin and oxycodone combination therapy for neuropathic pain in cancer patients. PLoS One. 2013;8(4):e59981. doi: 10.1371/journal.pone.0059981. Epub 2013 Apr 5. |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |