Adrenocorticotropic Axis and Neuropathic Pain (HORMONES)
| Tracking Information | |||||
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| First Received Date ICMJE | February 28, 2012 | ||||
| Last Updated Date | May 13, 2013 | ||||
| Start Date ICMJE | March 2012 | ||||
| Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
hormonal status of neuropathic patients (blood sample ) [ Time Frame: at day 0 ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01543425 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Adrenocorticotropic Axis and Neuropathic Pain | ||||
| Official Title ICMJE | Status of the Hypothalamic-pituitary-gonado- Adrenal Axis (HHSG) in Patients With Neuropathic Pain | ||||
| Brief Summary | Chronic pain is often associated with a chronic stress and HHSG axis plays a pivotal role in maintaining homeostasis. The literature reports that pain in patients treated with opioids, significant changes are taking place in this axis with a collapse in hormone concentrations that are correlated with the decline on tests of quality of life and psychological testing. The investigators hypothesis is that this "endocrinopathy" could also be present in patients treated for neuropathic pain with other drug classes as opiates (antidepressants, antiepileptics), and may explain, at least in part, the impairement of the quality of life of these patients. |
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| Detailed Description | Day of inclusion: Blood sample for analysis of several hormones (cortisol, ACTH, SHBG, total testostérone et S-DHEA, βœstradiol et progestérone for women, LH, FSH). Day +1: salivary samples (at wake-up, 30 minutes after wake-up, at lunch, at 06:00 pm and before sleep). Day +2: salivary samples (at wake-up, 30 minutes after wake-up). |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: None Retained Description: Day of inclusion: Blood sample for analysis of several hormones (cortisol, ACTH, SHBG, total testostérone et S-DHEA, βœstradiol et progestérone for women, LH, FSH). Day +1: salivary samples (at wake-up, 30 minutes after wake-up, at lunch, at 06:00 pm and before sleep). Day +2: salivary samples (at wake-up, 30 minutes after wake-up). |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients older than 18 years,
Group of healthy volunteers
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| Condition ICMJE | Neuropathic Pain | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 120 | ||||
| Completion Date | May 2013 | ||||
| Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Group of healthy volunteers
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01543425 | ||||
| Other Study ID Numbers ICMJE | CHU-0116 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | University Hospital, Clermont-Ferrand | ||||
| Study Sponsor ICMJE | University Hospital, Clermont-Ferrand | ||||
| Collaborators ICMJE | Pharmacologic center of the Hospital of Clermont-Ferrand | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Clermont-Ferrand | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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