Oxycodone and Pregabalin for the Treatment of Oncological Neuropathic Pain
NCT ID: NCT00637975
Last Updated: 2011-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2007-09-30
2010-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
oxycodone 20 mg/day plus pregabalin at increasing dose starting from 50 mg/day for 15 days or until unacceptable toxicity develops
oxycodone
Arm A - 20 mg/day
Arm B - increasing dose startnig at 20 mg/day
For 15 days or until unacceptable toxicity develops.
pregabalin
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
pregabalin 50 mg/day plus oxycodone at increasing dose starting from 20 mg/day. For 15 days or until unacceptable toxicity develops
oxycodone
Arm A - 20 mg/day
Arm B - increasing dose startnig at 20 mg/day
For 15 days or until unacceptable toxicity develops.
pregabalin
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.
Interventions
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oxycodone
Arm A - 20 mg/day
Arm B - increasing dose startnig at 20 mg/day
For 15 days or until unacceptable toxicity develops.
pregabalin
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.
Eligibility Criteria
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Inclusion Criteria
* presence of pain with a neuropathic component in the opinion of the physician
* presence of pain \>=4(NRS)
* PS ECOG \<3
* written informed consent
Exclusion Criteria
* mild or severe hepatic insufficiency
* iatrogenic neuropathy caused by chemotherapeutic agents
* previous allergic reactions to oxycodone and pregabalin
* pregnancy or breastfeeding
18 Years
ALL
No
Sponsors
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Mario Negri Institute for Pharmacological Research
OTHER
Associazione Progetto Oncologia UMAN.A
OTHER
Responsible Party
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Fatebenefratelli and Ophtalmic Hospital
Principal Investigators
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Gabriella Farina, MD
Role: PRINCIPAL_INVESTIGATOR
Fatebenefratelli and Ophtalmic Hospital
Locations
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Ospedale Fatebenefratelli
Benevento, Benevento, Italy
Ospedali Riuniti
Bergamo, Bergamo, Italy
Ospedale S. Orsola
Brescia, Brescia, Italy
Ospedale Serbelloni
Gorgonzola, Milano, Italy
Fatebenefratelli and Ophtalmic Hospital
Milan, Milano, Italy
Ospedale Civile di Legnano
Parabiago, Milano, Italy
Ospedale Fatebenefratelli
Roma, Roma, Italy
Ospedale Sacro Cuore
Negrar, Verona, Italy
Countries
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References
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Other Identifiers
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EudraCT Number 2007-005222-69
Identifier Type: -
Identifier Source: secondary_id
NEUROPAIN01
Identifier Type: -
Identifier Source: org_study_id
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