Evaluation of the Efficacy and Safety of Two Methadone Titration Methods for the Treatment of Cancer-related Pain With Inadequate Pain Relief or Intolerable Side Effects When Treated With Level 3 Opioids. (EQUIMETH2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Laboratoires Bouchara-Recordati
Sponsor:
Information provided by (Responsible Party):
Laboratoires Bouchara-Recordati
ClinicalTrials.gov Identifier:
NCT01793480
First received: February 14, 2013
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

This is a multicentric, randomized, open-label, phase IIIb national study, to evaluate the clinical effects (success/failure) of methadone for the treatment of cancer-related-pain in patients with inadequate pain relief or intolerable side effects when treated with level 3 opioid.

Principal objective is to compare the clinical effects (success/failure) of two methods of methadone titration in patients with cancer-related pain inadequately relieved or with intolerable side effects after treatment with level 3 opioid.

Secondary objectives are : Overall safety of methadone during the study, to describe the patients' characteristics, to describe the effects of methadone on pain relief, to describe the methadone administration, to evaluate patient's quality of life, to evaluate the prescriber's opinion regarding the handling of methadone initiation.


Condition Intervention Phase
Pain Related to Cancer
Drug: Methadone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IIIb Evaluation of the Efficacy and Safety of Two Methadone Titration Methods for the Treatment of Cancer-related Pain With Inadequate Pain Relief or Intolerable Side Effects When Treated With Level 3 Opioids.

Resource links provided by NLM:


Further study details as provided by Laboratoires Bouchara-Recordati:

Primary Outcome Measures:
  • Binary main criterion based on success/failure rate related to methadone switch on Day 4. [ Time Frame: Day 4 ] [ Designated as safety issue: No ]

    The success is defined as the adequate pain relief on Day 4 and no occurrence of overdose between Day 1 and Day 4. All unmet definition of success will be considered as a failure.

    The adequate pain relief is defined as the composite criterion:

    • Decrease of at least 2 points on the pain numeric scale from 0 (no pain) to 10 (unacceptable pain) evaluated on Day 4 when compared to the pain numeric scale score at baseline,
    • And a pain numeric scale score <5 during two consecutive days (between Day 1 and Day 4)


Estimated Enrollment: 146
Study Start Date: December 2011
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: patient-controlled dose of methadone
The titration will be done on the patient's request (patient-controlled dose of methadone), with no overlapping with the previous opioid treatment, under the investigator's supervision.
Drug: Methadone
Experimental: fixed-dose of methadone
The titration will be done with fixed-dose of methadone, on a progressive switch with overlapping with the previous opioid treatment, to avoid withdrawal syndrome when the opioid is discontinued.
Drug: Methadone

Detailed Description:

The randomisation (1:1) will consider the two titration methadone switching methods:

  • Group A: patient-controlled dose of methadone with no overlapping with the previous opioid treatment
  • Group B: fixed-dose of methadone with overlapping with the previous opioid treatment

Study Description:

Screening visit (Visit 1) within 48 hours before the inclusion Inclusion visit (Visit2) and randomisation on Day 1 Visit 3 from Day 2 to Day 7 (hospitalisation for all patients). Four follow-up visits on Day 14 (Visit 4), Day 21(Visit 5), Day 28 (Visit 6), Day 42 (Visit 7) End of study visit on Day 56 Follow-up phone contact on Day 84.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patient of at least 18 years of age
  • Patient suffering from cancer disease, undergoing chemotherapy treatment or not, hospitalised or requiring hospitalisation
  • Patient presenting nociceptive or mixed pains inadequately relieved with level 3 opioids (morphine, oxycodone, transdermal fentanyl, hydromorphone) with a numeric pain scale score ≥5 evidence-based or presenting intolerable side effects with level 3 opioids
  • Patient undergoing level 3 opioid treatment (morphine sulphate or morphine chlorhydrate or fentanyl or oxycodone or hydromorphone)
  • Patient presenting a good understanding of the study objectives and able to give his/her written consent
  • Patient able to communicate with the investigator or his representative
  • Patient available during the whole course of the study and agreeing the study requirements
  • Patient with Social Insurance
  • Patient having received patient's information form, orally informed and having signed the consent form

Exclusion Criteria:

  • Patient in terminal cancer disease (life expectancy less than 2 months) according to investigator's judgement
  • Patient treated with a medication that may result in an interaction with methadone, such as: antiarrythmic treatments (Ia or III), erythromycin, spiramycin, intravenous vincamin
  • Patient receiving opioid treatment for any other reason than pain
  • Patient unable to swallow the study treatment
  • Patient presenting contra-indication to the use of methadone
  • Patient having a decompensated respiratory failure or a severe hepatic disease
  • Patient having a known hypersensitivity to methadone
  • Patient presenting QT interval prolongation on ECG results
  • Patient receiving a concomitant treatment with a morphine-type agonist-antagonist medication (pentazocine, buprenorphine, nalbuphine) or with sultopride, or with morphinic antagonist (naltrexone)
  • Patient treated by analgesic radiotherapy within 15 days before inclusion
  • Patient participating or having participated in another clinical trial with a new therapy within one month before inclusion
  • Patient with a history of substance abuse
  • For woman with childbearing potential: pregnancy or breastfeeding.
  • Forfeiture of freedom or under guardianship
  • Past history of suicidal attempts
  • Patient likely not to respect the study conditions and/or study discontinuation criteria according to investigator's judgement
  • Patient presenting any other medical condition or illness or clinically significant abnormal findings on the physical examination at screening that, in the opinion of the Investigator, make the patient unsuitable for the study or put the patient at additional risk.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01793480

Contacts
Contact: Shimsi Lefki, Dr 33145191103 s.lefki@bouchara-recordati.fr

Locations
France
Investigational Site 10 Recruiting
Amiens, France
Investigational Site 06 Recruiting
Bayonne, France
Investigational Site 13 Recruiting
Caen, France
Investigational Site 03 Recruiting
GAP, France
Investigational Site 11 Recruiting
Le Chesnay, France
Investigational Site 07 Recruiting
Lille, France
Investigational Site 16 Recruiting
Lyon, France
Investigational Site 12 Recruiting
Nice, France
Investigational Site 14 Active, not recruiting
Paris, France
Investigational Site 02 Recruiting
Pierre Benite, France
Investigational Site 05 Recruiting
Reims, France
Investigational site 08 Recruiting
Strasbourg, France
Investigational Site 17 Recruiting
Suresnes, France
Investigational Site 01 Recruiting
Tarbes, France
Investigational Site 04 Active, not recruiting
Toulouse, France
Investigational Site 15 Recruiting
Villejuif, France
Sponsors and Collaborators
Laboratoires Bouchara-Recordati
  More Information

No publications provided

Responsible Party: Laboratoires Bouchara-Recordati
ClinicalTrials.gov Identifier: NCT01793480     History of Changes
Other Study ID Numbers: 2011-004609-26
Study First Received: February 14, 2013
Last Updated: February 15, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Laboratoires Bouchara-Recordati:
Methadone in cancer pain

Additional relevant MeSH terms:
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 16, 2014