AzTrials
AzTrials

PainPhase 3RATIOMTDNCT01836328

Conversion From Parenteral to Oral Methadone.

A Phase 3 study testing Parenteral /oral methadone ratio 1:2 and Parenteral /oral methadone ratio 1:1.2 in people with Pain, run by L'Hospitalet de Llobregat at 3 sites in Spain.

Completed

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

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain
What is being tested?
Parenteral /oral methadone ratio 1:2 and Parenteral /oral methadone ratio 1:1.2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
3 sitesSpain
Study dates
Aug 2011to Jun 2015
Phase
Phase 3
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

  • diagnosis of advanced disease of any type of malignancy;
  • >18 years old at the time of inclusion;
  • for inclusion in the screening phase, the patient is a candidate to pass parenteral methadone to oral methadone (MTD) following to the physician criteria.
  • for inclusion in the assessment phase should follow: presence of cancer pain controlled with no significant toxicity with MTD VP for 48h. Be considered controlled pain and absence of significant toxicity due to MTD, as the definitions given in the general protocol;
  • signing the informed consent form.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

  • Institut Català D'Ncologia. Hospital Duran Y Reynals

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Arnau de Vilanova

    Lleida, Lleida, 25198

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

Other trials in Spain

About this study

Official title: Prospective Randomized Simple Blinded Study Comparing Two Conversion Ratios From Parenteral to Oral Methadone in Patients With Cancer Pain.

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

Read the detailed description

OBJECTIVE: To compare the different ratios of conversion from MTD VP to MTD PO. To verify the presence of lower toxicity in the ratio 1:1.2 against 1:2 while still maintaining a good control of pain in patients with advanced cancer that are hospitalized in different palliative care units.

METHODOLOGY: Prospective randomized single blind study in patients with cancer pain treated with parenteral MTD and that would move into MTD oral provided there is good control of pain. The patients will be randomly split into two groups: (Group A = ratio 1:1.2 and Group B=ratio 1:2). Patients will be evaluated during the two days before the switch is applied, the day of the change and during the 3 days post-ROP. The patients who display significant toxicity and/or bad analgesic control within the first 72 hours post-ROP will be considered negative cases. The size of the sample required will include 44 patients distributed in balanced groups in order to obtain a size effect of 45% and a statistical power of 80%. The significance level will be 0.05 for two tails.

STATISTIC ANALYSIS: By means of Chi-squared to compare the proportion of Opioid Rotation (OR) failure in both groups of study.

Conditions
Pain
Being tested
Parenteral /oral methadone ratio 1:2, Parenteral /oral methadone ratio 1:1.2
Keywords
Methadone, Pain, Neoplasms, Ratio
Medical subject headings
Pain, Neoplasms

What participants receive

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

  • Parenteral /oral methadone ratio 1:2Drug

    Also called Eptadone (1mg/ml) oral solution

    See "arm/group descriptions"

  • Parenteral /oral methadone ratio 1:1.2Drug

    Also called Eptadone (1mg/ml) oral solution

    See "arm/group descriptions"

Study groups in NCT01836328
Study groupRoleWhat they receive
Parenteral /oral methadone ratio 1:2Active comparatorFar 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.
Receives: Drug: Parenteral /oral methadone ratio 1:2
Parenteral /oral methadone ratio 1:1.2ExperimentalFar 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.
Receives: Drug: Parenteral /oral methadone ratio 1:1.2

What is being measured

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

  1. Proportion of intoxicated patients in each groups

    Measured: at 3 days after opioid rotation to Oral Methadone

Secondary outcomes (1)

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

    Measured: One week after the change from pareteral to oral MTD

Timeline

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

  1. First posted19 Apr 2013 (estimated)
  2. Study startAug 2011
  3. Primary completionJun 2015
  4. Study completionJun 2015

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 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01836328
Sponsor's protocol ID
RATIOMTD-010810
Other IDs
2010-024092-39, EC10-133
Acronym
RATIOMTD
Status last verified
Mar 2016
First submitted
17 Apr 2013
Last updated
16 Mar 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19042849

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Parenteral /oral methadone ratio 1:2 and Parenteral /oral methadone ratio 1:1.2 in people with Pain, run by L'Hospitalet de Llobregat at 3 sites in Spain.

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 7 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 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Proportion of intoxicated patients in each groups (time frame: at 3 days after opioid rotation to Oral Methadone). 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 NCT01836328, which also lists 1 linked publication.

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 16 Mar 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in