Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tramadol Clinical Efficiency and Tolerance Correlated to O-desmethyltramadol/Tramadol Ratio (CLINCYTRAM) (CLINCYTRAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03357003
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:

Tramadol is a grade II analgesics as World Health Organization definition. It can both be an agonist on mu receptors, which provides it a low opioid action, and also be a Serotonin-norepinephrine reuptake inhibitor, which act on neuropathic pain.

Tramadol is metabolized by P450 2D6 cytochrome (CYP2D6) in O-desmethyltramadol (O-dt) which is the most active form on the pharmacologic side (analgesic effect 2 to 4 times more powerful than tramadol itself).

In caucasian population, 5 to 10% of patients are genetically qualified as "poor metabolizer phenotype"; this status is correlated to a lower analgesic efficiency compared to "rapid metabolizer".

A multicenter study, CYTRAM, is under publication and allowed measurement of blood ratio O-dT/tramadol as a way to know the phenotype of CYP2D6 to detect "poor metabolizer phenotype" status.

Indeed, blood ratio O-dT/tramadol threshold under 0.1 detects " poor metabolizer phenotype " status for postoperative patients treated by tramadol, with a good sensibility (87,5%) and specificity (83.8%).

Which impacts for current practice? The next step is to know if this blood ratio is linked to an analgesic efficiency and a good tolerance for tramadol. A "poor metabolizer phenotype" patient would have no benefit of tramadol posology increasing. Therefore, phenotype detection, thank to blood ratio, could allow to switch quickly tramadol to another analgesic treatment for "poor metabolizer phenotype" patients.

The main objective of the study is to forge a link between O-dT/tramadol ratio and analgesic efficiency. Secondary objectives investigate side effects and frequency related to O-dT/tramadol ratio and pain relief, and also impact of CYP2D6 - inhibitor treatments on the blood ratio.

If there is a correlation between this blood ratio and treatment efficiency and tolerance, O-dT/tramadol ratio's detection will allow a better adaptation for some treatments metabolized by CYP2D6. Therefore, this evolution will contribute to health quality and health safety improvement.


Condition or disease Intervention/treatment
Pain Other: Observational study

Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study (and Blood Samples Without Genetics Analysis) Tramadol Clinical Efficiency and Tolerance Correlated to O-desmethyltramadol/Tramadol Ratio (CLINCYTRAM)
Actual Study Start Date : December 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol


Intervention Details:
  • Other: Observational study
    Comparison between O-desmethyltramadol/tramadol ratio and tramadol clinical efficiency and tolerance


Primary Outcome Measures :
  1. Ratio measurement : O-desmethyltramadol blood concentration/ tramadol blood concentration [ Time Frame: at 48 hours ]
  2. visual analogic pain scale (1 to 10) [ Time Frame: at 48 hours ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suffering from nociceptive pain, combined or not with neuropathic pain, requiring tramadol treatment, grade II analgesics (WHO)
Criteria

Inclusion Criteria:

  • Patients >18 years old treated by tramadol for at least 48h
  • Tramadol posology between 100 and 400 mg/d (oral treatment) and until 600 mg/d (veinous treatment), recommended dosage
  • Patients with nociceptive pain, definite etiology, combined or not with neuropathic pain
  • Caucasian patient
  • Patient able to give his/her informed consent
  • Patient able to estimate himself/herself pain with pain scale for at least 48h

Exclusion Criteria:

  • Age < 18 years old
  • Patient with chronic pain (>3 month) or not definite
  • Tramadol posology >400 mg/d (oral treatment) or > 600 mg/d (veinous treatment)
  • Patients with absolute Tramadol contraindication
  • Chronic endstage kidney failure antecedent (Cl cockcroft < 10mL/min) and liver failue antecedent
  • Concomitant analgesic treatment, except paracetamol or stopped less than 48h ago
  • Pregnant or breast-feeding patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357003


Contacts
Layout table for location contacts
Contact: Anne Sophie Jossome, MD 02 31 06 31 06

Locations
Layout table for location information
France
Caen University Hospital Recruiting
Caen, France
Contact: AS Jossomme, MD         
Sponsors and Collaborators
University Hospital, Caen

Layout table for additonal information
Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03357003     History of Changes
Other Study ID Numbers: CaenUH
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Tramadol
O-demethyltramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents