Oxycodone and Pregabalin for the Treatment of Oncological Neuropathic Pain

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637975
• Other study ID #: NEUROPAIN01
• Secondary ID: EudraCT Number 2
• Status: Completed
• Phase: Phase 2
• First received: March 12, 2008
• Last updated: February 1, 2011
• Start date: September 2007
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: Associazione Progetto Oncologia UMAN.A
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: Ministry of HealthItaly: National Institute of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• instrumental and clinical diagnosis of every malignant neoplasm

• 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:

• serum creatinine >2mg/ml or creatinine clearance <40 ml/min

• mild or severe hepatic insufficiency

• iatrogenic neuropathy caused by chemotherapeutic agents

• previous allergic reactions to oxycodone and pregabalin

• pregnancy or breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Neuralgia
• Pain

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Italy	Ospedale Fatebenefratelli	Benevento
Italy	Ospedali Riuniti	Bergamo
Italy	Ospedale S. Orsola	Brescia
Italy	Ospedale Serbelloni	Gorgonzola	Milano
Italy	Fatebenefratelli and Ophtalmic Hospital	Milano
Italy	Ospedale Sacro Cuore	Negrar	Verona
Italy	Ospedale Civile di Legnano	Parabiago	Milano
Italy	Ospedale Fatebenefratelli	Roma

Sponsors (2)

Lead Sponsor	Collaborator
Associazione Progetto Oncologia UMAN.A	Mario Negri Institute for Pharmacological Research

Country where clinical trial is conducted

Italy, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale		within 15 days	No
Secondary	Pain control rate		within 15 days	No
Secondary	Reduction of Break Through Pain number		within 15 days	No
Secondary	Record of adverse events		within 15 days	Yes
Secondary	Reduction of allodynia in patients presenting it at T0		within 15 days	No
Secondary	Patient satisfaction		within 15 days	No
Secondary	Assessing whether COMT and mu blood polymorphisms are associated to response		within 15 days	No