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Sponsors and Collaborators: |
Associazione Progetto Oncologia UMAN.A Mario Negri Institute for Pharmacological Research |
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Information provided by: | Associazione Progetto Oncologia UMAN.A |
ClinicalTrials.gov Identifier: | NCT00637975 |
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.
Condition | Intervention | Phase |
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Cancer Pain |
Drug: oxycodone Drug: pregabalin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Phase II Trial Evaluating Activity and Tolerability of Fixed Dose of Oxycodone and Increasing Dose of Pregabalin Versus Increasing Dose of Oxycodone and Fixed Dose of Pregabalin for the Treatment of Oncological Neuropathic Pain |
Estimated Enrollment: | 80 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
oxycodone 20 mg/day plus pregabalin at increasing dose starting from 50 mg/day for 15 days or until unacceptable toxicity develops
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Drug: oxycodone
Arm A - 20 mg/day Arm B - increasing dose startnig at 20 mg/day For 15 days or until unacceptable toxicity develops. 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. |
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
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Drug: oxycodone
Arm A - 20 mg/day Arm B - increasing dose startnig at 20 mg/day For 15 days or until unacceptable toxicity develops. 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. |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gabriella Farina, MD | +39 02 6363 2223 | gabriella.farina@fbf.milano.it |
Contact: Aurora Rizzo, MSD | +39 02 6363 2223 | oncologia.ricerca@fbf.milano.it |
Italy | |
Ospedale Fatebenefratelli | Recruiting |
Benevento, Italy, 82100 | |
Contact: Antonio Febbraro, MD +39 3403371731 antoniofebbraro@virgilio.it | |
Principal Investigator: Antonio Febbraro, MD | |
Ospedali Riuniti | Not yet recruiting |
Bergamo, Italy, 24123 | |
Contact: Roberto Labianca, MD +39 035269111 RLabianca@ospedaliriuniti.bergamo.it | |
Principal Investigator: Roberto Labianca, MD | |
Sub-Investigator: Cecilia Moro, MD | |
Ospedale S. Orsola | Recruiting |
Brescia, Italy, 25122 | |
Contact: Giordano Beretta, MD +39 0302971224 gdberetta@fatebenefratelli.it | |
Principal Investigator: Giordano Beretta, MD | |
Fatebenefratelli and Ophtalmic Hospital | Recruiting |
Milano, Italy, 20121 | |
Contact: Gabriella Farina, MD +39 0263632223 gabriella.farina@fbf.milano.it | |
Contact: Aurora Rizzo, PharmD +39 0263632223 aurora.rizzo@gmail.com | |
Principal Investigator: Gabriella Farina, MD | |
Sub-Investigator: Marina C Garassino, MD | |
Ospedale Fatebenefratelli | Recruiting |
Roma, Italy | |
Contact: Enrico Breda, MD +39 330291335 enricobreda@libero.it | |
Principal Investigator: Enrico Breda, MD | |
Italy, Milano | |
Ospedale Civile di Legnano | Recruiting |
Parabiago, Milano, Italy, 20015 | |
Contact: Elena Collovà, MD +39 3478632345 laelena75@hotmail.com | |
Sub-Investigator: Elena Collovà, MD | |
Principal Investigator: Sergio Fava, MD | |
Ospedale Serbelloni | Recruiting |
Gorgonzola, Milano, Italy, 29964 | |
Contact: Luciano Isa, MD +39 0295707207 luciano.isa@aospmelegnano.it | |
Principal Investigator: Luciano Isa, MD | |
Sub-Investigator: Claudia Carbone, MD | |
Italy, Verona | |
Ospedale Sacro Cuore | Recruiting |
Negrar, Verona, Italy, 37024 | |
Contact: Roberto Magarotto, MD +39 0456013111 roberto.magarotto@sacrocuore.it | |
Sub-Investigator: Roberto Magarotto, MD | |
Principal Investigator: Marco Venturini, MD | |
Sub-Investigator: Francesca Coati |
Principal Investigator: | Gabriella Farina, MD | Fatebenefratelli and Ophtalmic Hospital |
Responsible Party: | Fatebenefratelli and Ophtalmic Hospital ( Gabriella Farina ) |
Study ID Numbers: | NEUROPAIN01, EudraCT Number 2007-005222-69 |
Study First Received: | March 12, 2008 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00637975 History of Changes |
Health Authority: | Italy: Ethics Committee; Italy: Ministry of Health; Italy: National Institute of Health; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Italy: The Italian Medicines Agency |
neuropathic pain oxycodone pregabalin Patients with cancer and presenting a neuropathic pain |
Oxycodone Central Nervous System Depressants Pregabalin Narcotics Pain |
Peripheral Nervous System Agents Analgesics Anticonvulsants Analgesics, Opioid |
Oxycodone Physiological Effects of Drugs Pregabalin Central Nervous System Depressants Narcotics Pharmacologic Actions Sensory System Agents |
Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid Anticonvulsants |