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Spots Global Cancer Trial Database for 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.

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Trial Identification

Brief Title: 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.

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.

Study ID: NCT01793480

Interventions

Methadone

Study Description

Brief Summary: 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.

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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Investigational Site 10, Amiens, , France

Investigational Site 06, Bayonne, , France

Investigational Site 13, Caen, , France

Investigational Site 03, GAP, , France

Investigational Site 11, Le Chesnay, , France

Investigational Site 07, Lille, , France

Investigational Site 16, Lyon, , France

Investigational Site 12, Nice, , France

Investigational Site 14, Paris, , France

Investigational Site 02, Pierre Benite, , France

Investigational Site 05, Reims, , France

Investigational site 08, Strasbourg, , France

Investigational Site 17, Suresnes, , France

Investigational Site 01, Tarbes, , France

Investigational Site 04, Toulouse, , France

Investigational Site 15, Villejuif, , France

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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