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CancerPhase 2NCT00637975

Oxycodone and Pregabalin for the Treatment of Oncological Neuropathic Pain

A Phase 2 study testing oxycodone and pregabalin in people with Cancer and Pain, run by Associazione Progetto Oncologia UMAN.A at 8 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Pain
What is being tested?
oxycodone and pregabalin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
8 sitesItaly
Study dates
Sep 2007to Dec 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Italy8 sites

  • Ospedale Fatebenefratelli

    Benevento, Benevento, 82100

  • Ospedali Riuniti

    Bergamo, Bergamo, 24123

  • Ospedale S. Orsola

    Brescia, Brescia, 25122

  • Ospedale Serbelloni

    Gorgonzola, Milano, 29964

  • Fatebenefratelli and Ophtalmic Hospital

    Milan, Milano, 20121

  • Ospedale Sacro Cuore

    Negrar, Verona, 37024

  • Ospedale Civile di Legnano

    Parabiago, Milano, 20015

  • Ospedale Fatebenefratelli

    Roma, Roma

Other trials in Italy

About this 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

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.

Read the detailed 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.

Conditions
Cancer, Pain
Being tested
oxycodone, pregabalin
Keywords
neuropathic pain, oxycodone, pregabalin, Patients with cancer and presenting a neuropathic pain
Medical subject headings
Neoplasms, Pain, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oxycodoneDrug

    Arm A - 20 mg/day

    Arm B - increasing dose startnig at 20 mg/day

    For 15 days or until unacceptable toxicity develops.

  • pregabalinDrug

    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.

Study groups in NCT00637975
Study groupRoleWhat they receive
AExperimentaloxycodone 20 mg/day plus pregabalin at increasing dose starting from 50 mg/day for 15 days or until unacceptable toxicity develops
Receives: Drug: oxycodone; Drug: pregabalin
BActive comparatorpregabalin 50 mg/day plus oxycodone at increasing dose starting from 20 mg/day. For 15 days or until unacceptable toxicity develops
Receives: Drug: oxycodone; Drug: pregabalin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale

    Measured: within 15 days

Secondary outcomes (6)

  1. Pain control rate

    Measured: within 15 days

  2. Reduction of Break Through Pain number

    Measured: within 15 days

  3. Record of adverse events

    Measured: within 15 days

  4. Reduction of allodynia in patients presenting it at T0

    Measured: within 15 days

  5. Patient satisfaction

    Measured: within 15 days

  6. Assessing whether COMT and mu blood polymorphisms are associated to response

    Measured: within 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2008 (estimated)
  2. Study startSep 2007
  3. Primary completionDec 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00637975
Sponsor's protocol ID
NEUROPAIN01
Other IDs
EudraCT Number 2007-005222-69
Status last verified
Jan 2011
First submitted
12 Mar 2008
Last updated
2 Feb 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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

  • 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.

    PubMed 11981518

  • Riley J, Ross JR, Rutter D, Wells AU, Goller K, du Bois R, Welsh K. No pain relief from morphine? Individual variation in sensitivity to morphine and the need to switch to an alternative opioid in cancer patients. Support Care Cancer. 2006 Jan;14(1):56-64. doi: 10.1007/s00520-005-0843-2. Epub 2005 Jun 11.

    PubMed 15952009

  • Mucci-LoRusso P, Berman BS, Silberstein PT, Citron ML, Bressler L, Weinstein SM, Kaiko RF, Buckley BJ, Reder RF. Controlled-release oxycodone compared with controlled-release morphine in the treatment of cancer pain: a randomized, double-blind, parallel-group study. Eur J Pain. 1998;2(3):239-49. doi: 10.1016/s1090-3801(98)90020-9.

    PubMed 15102384

  • Bruera E, Belzile M, Pituskin E, Fainsinger R, Darke A, Harsanyi Z, Babul N, Ford I. Randomized, double-blind, cross-over trial comparing safety and efficacy of oral controlled-release oxycodone with controlled-release morphine in patients with cancer pain. J Clin Oncol. 1998 Oct;16(10):3222-9. doi: 10.1200/JCO.1998.16.10.3222.

    PubMed 9779695

  • Altier N, Dion D, Boulanger A, Choiniere M. Management of chronic neuropathic pain with methadone: a review of 13 cases. Clin J Pain. 2005 Jul-Aug;21(4):364-9. doi: 10.1097/01.ajp.0000125247.95213.53.

    PubMed 15951657

  • Gralow I. Cancer pain: an update of pharmacological approaches in pain therapy. Curr Opin Anaesthesiol. 2002 Oct;15(5):555-61. doi: 10.1097/00001503-200210000-00014.

    PubMed 17019254

  • Farrar JT, Portenoy RK. Neuropathic cancer pain: the role of adjuvant analgesics. Oncology (Williston Park). 2001 Nov;15(11):1435-42, 1445; discussion 1445, 1450-3.

    PubMed 11758872

  • Dirks J, Petersen KL, Rowbotham MC, Dahl JB. Gabapentin suppresses cutaneous hyperalgesia following heat-capsaicin sensitization. Anesthesiology. 2002 Jul;97(1):102-7. doi: 10.1097/00000542-200207000-00015.

    PubMed 12131110

  • Caraceni A, Zecca E, Bonezzi C, Arcuri E, Yaya Tur R, Maltoni M, Visentin M, Gorni G, Martini C, Tirelli W, Barbieri M, De Conno F. Gabapentin for neuropathic cancer pain: a randomized controlled trial from the Gabapentin Cancer Pain Study Group. J Clin Oncol. 2004 Jul 15;22(14):2909-17. doi: 10.1200/JCO.2004.08.141.

    PubMed 15254060

  • Mercadante S, Arcuri E, Tirelli W, Villari P, Casuccio A. Amitriptyline in neuropathic cancer pain in patients on morphine therapy: a randomized placebo-controlled, double-blind crossover study. Tumori. 2002 May-Jun;88(3):239-42. doi: 10.1177/030089160208800310.

    PubMed 12195763

  • Grond S, Zech D, Diefenbach C, Radbruch L, Lehmann KA. Assessment of cancer pain: a prospective evaluation in 2266 cancer patients referred to a pain service. Pain. 1996 Jan;64(1):107-114. doi: 10.1016/0304-3959(95)00076-3.

    PubMed 8867252

  • Portenoy RK, Foley KM, Inturrisi CE. The nature of opioid responsiveness and its implications for neuropathic pain: new hypotheses derived from studies of opioid infusions. Pain. 1990 Dec;43(3):273-286. doi: 10.1016/0304-3959(90)90025-9.

    PubMed 1705692

  • Chua KS, Reddy SK, Lee MC, Patt RB. Pain and loss of function in head and neck cancer survivors. J Pain Symptom Manage. 1999 Sep;18(3):193-202. doi: 10.1016/s0885-3924(99)00070-6.

    PubMed 10517041

  • Zech DFJ, Grond S, Lynch J, Hertel D, Lehmann KA. Validation of World Health Organization Guidelines for cancer pain relief: a 10-year prospective study. Pain. 1995 Oct;63(1):65-76. doi: 10.1016/0304-3959(95)00017-M.

    PubMed 8577492

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing oxycodone and pregabalin in people with Cancer and Pain, run by Associazione Progetto Oncologia UMAN.A at 8 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale (time frame: within 15 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00637975, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2011.

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