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

NCT03357003 | Unknown

• 1 other identifier: CaenUH
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• Ratio measurement : O-desmethyltramadol blood concentration/ tramadol blood concentration

  at 48 hours

• visual analogic pain scale (1 to 10)

  at 48 hours

Interventions

Observational study OTHER

Comparison between O-desmethyltramadol/tramadol ratio and tramadol clinical efficiency and tolerance

Eligibility Criteria

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

Study Population

Patients suffering from nociceptive pain, combined or not with neuropathic pain, requiring tramadol treatment, grade II analgesics (WHO)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, France

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Anne Sophie Jossome, MD

CONTACT

02 31 06 31 06

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: November 29, 2017
• Study Start: December 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

FR (1)