Conversion From Parenteral to Oral Methadone.

NCT01836328 | Completed Phase 3 DMC

• 3 other identifiers: RATIOMTD-0108102010-024092-39EC10-133
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

Brief Summary

The majority of current studies regarding the use of methadone (MTD) in the treatment of cancer pain are focused in its administration via the oral route (PO). The ratio considered from VO to parenteral route (BP) is 2:1. Academic literature assumes the ratio from BP to VO to be 1:2. In our unit, we use MTD in the context of ROP and not as the last opioid. If face with a situation where there is a good control of pain with MTD BP, usually we move to VO. We have observed that the traditional ratio tend to produce certain toxicity problems. Because of this, we have proposed a new ratio of conversion from PAR MTD to oral MTD, i.e. 1:1.2

Conditions

Pain

Keywords

Methadone; Pain; Neoplasms; Ratio

Outcome Measures

Primary Outcomes (1)

• Proportion of intoxicated patients in each groups

  at 3 days after opioid rotation to Oral Methadone

Secondary Outcomes (1)

• Parenteral/oral MTD final ratio in patients considered as "failure"

  One week after the change from pareteral to oral MTD

Study Arms (2)

Parenteral /oral methadone ratio 1:2

ACTIVE COMPARATOR

Far advanced cancer patients with cancer pain hospitalized, and treated with PMTD undergo a preliminary 48 hours observation phase. Blinded evaluators assess pain management and treatment toxicity and determine an OPTIMISED DOSE of parenteral METHADONE (pain control without toxicity) for each patient. Only patients with a correct control of pain and without significant toxicity throughout this period are eligible for randomization. INTERVENTION: Patients randomized to this arm will receive the double of OPTIMISED DOSE of parenteral METHADONE, orally every 24h in 3 administrations during the following 3 days.

Drug: Parenteral /oral methadone ratio 1:2

Parenteral /oral methadone ratio 1:1.2

EXPERIMENTAL

Far advanced cancer patients with cancer pain hospitalized, and treated with PMTD undergo a preliminary 48 hours observation phase. Blinded evaluators assess pain management and treatment toxicity and determine an OPTIMISED DOSE of parenteral METHADONE (pain control without toxicity) for each patient. Only patients with a correct control of pain and without significant toxicity throughout this period are eligible for randomization. INTERVENTION: Patients randomized to this arm will receive the following Oral Methadone dose: 20% increase of optimised parenteral methadone dose every 24h in 3 administrations during the following 3 days.

Drug: Parenteral /oral methadone ratio 1:1.2

Interventions

Parenteral /oral methadone ratio 1:2 DRUG

See "arm/group descriptions"

Also known as: Eptadone (1mg/ml) oral solution

Parenteral /oral methadone ratio 1:2

Parenteral /oral methadone ratio 1:1.2 DRUG

See "arm/group descriptions"

Also known as: Eptadone (1mg/ml) oral solution

Parenteral /oral methadone ratio 1:1.2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of advanced disease of any type of malignancy;
• e) signing the informed consent form.

You may not qualify if:

• impairment cognitive status that interferes with the assessment;
• diagnosis of psychiatric disorders at the time of recruitment that alters the ability to evaluate;
• presence of side effects due to chemotherapy and / or radiotherapy prior to the change of route of administration, taking into account the following two criteria:
• For patients on a protocol of successive cycles of chemotherapy (no change in chemotherapy regimen), having presented side effects due to chemotherapy in the 15 days prior to the change of route of administration as clinically and following the recommendations of the 2011 4th ed Oncomecum of the Spanish Society of Medical Oncology and deemed that may interfere with the assessment of the primary endpoint.
• For patients starting a new protocol of chemotherapy or radiotherapy, have submitted side effects due to such treatment in the 28 days prior to the change of route of administration based on clinical judgment and following the recommendations of the Oncomecum 2011 4th ed. of the Spanish Society of Medical Oncology and deemed that may interfere with the assessment of the primary endpoint.
• invasive anesthesic techniques have been made during the 3 days before changing to oral parenteral;
• patients at agony.

Sponsors & Collaborators

• L'Hospitalet de Llobregat: lead
• Hospital Arnau de Vilanova: collaborator
• Hospital Universitario La Paz: collaborator

Study Sites (3)

Institut Català D'Ncologia. Hospital Duran Y Reynals

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Arnau de Vilanova

Lleida, Lleida, 25198, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Related Publications (1)

• Gonzalez-Barboteo J, Porta-Sales J, Sanchez D, Tuca A, Gomez-Batiste X. Conversion from parenteral to oral methadone. J Pain Palliat Care Pharmacother. 2008;22(3):200-5. doi: 10.1080/15360280802251199.

  PMID: 19042849 BACKGROUND

MeSH Terms

Conditions

Pain; Neoplasms

Interventions

Injections; Solutions

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Pharmaceutical Preparations

Study Officials

• JESÚS GONZÁLEZ-BARBOTEO, MD

  INSTITUT CATALÀ D'ONCOLOGIA. HOSPITAL DURAN I REYNALS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MEDICAL DOCTOR

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 19, 2013
• Study Start: August 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

ES (3)