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OBSERVATIONAL STUDY OF THE MANAGEMENT OF PATIENTS WITH CHRONIC PAIN (OKAPI)

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ClinicalTrials.gov Identifier: NCT03319238
Recruitment Status : Unknown
Verified October 2017 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : October 24, 2017
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Tracking Information
First Submitted Date September 7, 2017
First Posted Date October 24, 2017
Last Update Posted Date October 24, 2017
Actual Study Start Date July 7, 2016
Estimated Primary Completion Date September 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 19, 2017)
Descriptive analysis of benefit [ Time Frame: At baseline ]
Benefits (pain release after ketamine use) will be assessed by the Pain by the Numerical Pain Rating Scale (NPRS): the scale ranges from 0 no pain to 10 maximal tolerable pain, and risks will be assessed by collecting the ketamine adverse events reported by the patient and by the physician.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: October 19, 2017)
  • Descriptive analysis of risk (by collecting adverse event) of ketamine use. [ Time Frame: At baseline ]
    Biological statements will be collected during the usual care of patients, if possible (ASAT, ALAT, total bilirubin, conjugate bilirubin, free bilirubin, gamma glutamyl transferase, alkaline phosphatase,…)
  • Neuropathic Pain in 4 questions (DN4), [ Time Frame: At baseline ]
    The Neuropathic pain in 4 questions (DN4) at baseline only. DN4 is a clinical tool for the diagnosis of neuropathic pain. This questionnaire has four questions divided into 10 items related to the interview (ie, symptoms) and to the sensory examination (ie, signs). The investigator asks and examines the patient and notes a response "no" or "yes" for each item: "yes" is scored as "1" and "no" is scored as "0". The sum of scores gives the total score of the patient (/10). DN4 is considered as positive if the patient obtains a score of 4/10.
  • Patient Global Impression of Change, the characteristics of pain (PGIC) [ Time Frame: At baseline ]
    The Patient Global Impression of Change is a scale of global perception of change ("Deterioration" or "Improvement") realized at each telephone call except for baseline. This scale is graduated from 1 = very strongly improved to 7 = very strongly aggravated
  • Emotional status by Hospital Anxiety and Depression scale (HAD) [ Time Frame: At baseline ]
    The HAD scale is a self-administered questionnaire in 14 items completed by the patient. It is used to determine the levels of anxiety and depression. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Global score ranges from 0 to 42.
  • Quality of life (Short Form 12 items Short Form survey) [ Time Frame: At baseline ]
    assessed by a quality of life questionnaire (Short Form 12 items Short Form survey (SF12)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title OBSERVATIONAL STUDY OF THE MANAGEMENT OF PATIENTS WITH CHRONIC PAIN
Official Title OBSERVATIONAL STUDY OF THE MANAGEMENT OF PATIENTS WITH CHRONIC PAIN
Brief Summary The aim of this study is to evaluate the safety of use, benefits and risks of repeated use of ketamine for each patient with chronic pain in different structures of pain management.
Detailed Description This is an observational, longitudinal and multicenter study about use of ketamine. Benefits are assessed with pain intensity, anxiety, depression, quality of life and global impression of change. Risks are also assessed with adverse event collection.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with chronic pain
Condition Chronic Pain
Intervention Other: ketamine
The aim of this study is to evaluate the safety of use, benefits and risks of repeated use of ketamine for each patient with chronic pain in different structures of pain management.
Study Groups/Cohorts Patient cohort
Neuropathic pain patient taking ketamine
Intervention: Other: ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 19, 2017)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 1, 2018
Estimated Primary Completion Date September 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Aged over 18 years
  • Patients with chronic pain (more than 6 months)
  • Patients with peripheral or central neuropathic pain, fibromyalgia, algoneurodystrophy

Exclusion Criteria:

  • Patient under 18 years of age,
  • Patient not requiring prescription of ketamine
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03319238
Other Study ID Numbers CHU-349
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor University Hospital, Clermont-Ferrand
Collaborators Not Provided
Investigators
Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date October 2017