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NCT02989792 Clinical Trial

A Study to Investigate the Genetic Variation of Dopamine Pathway in Patients With Chronic Pain

Osteoarthritis Clinical Trial

Official title:
A Study to Investigate the Genetic Variation of Dopamine Pathway Associated With the Observed Effects of a New Treatment in Former Studies in Patients With Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02989792
Other study ID # T1001-03
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 8, 2017
Est. completion date October 5, 2017

Study information
Verified date May 2019
Source Tools4Patient
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients having completed former trials T1001-01 or T1001-02 will undergo one blood sampling for genotyping purposes. In addition they will compete the personality questionnaires they had completed in the former trial.

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date October 5, 2017
Est. primary completion date October 5, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- have completed T1001-01 or T1001-02 study (Visit 5 completed)

- are men or women of at least 18 years of age

- have given written informed consent approved by the relevant Ethics Committee governing the study sites

Exclusion Criteria:

- have any close relationship with the Investigators or the Sponsor

- are under legal protection, according to the national law

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• Blood sampling for genotyping
Venous punction of maximum 10 millilitres
Other:
• Personality Questionnaires completion
Completion of the following questionnaires: Multidimensional Personality Questionnaire (MPSQ), Interpersonal Reactivity Index (IRI) and Behavioral inhibition system/ Behavioral activation systems (BISBAS) questionnaires

Locations
Country Name City State
Belgium ATC SA Liege
France CIC Clermont-Ferrand CHU G. Montpied Clermont-Ferrand
France Eurofins Optimed Gieres
France Institut Curie Paris

Sponsors (1)
Lead Sponsor Collaborator
Tools4Patient

Countries where clinical trial is conducted

Belgium,  France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with Single Nucleotide Polymorphisms (SNPs) variation of catechol-O-methyltransferase SNPs will be analyzed with Sanger based genotyping or equivalent method Time zero equals baseline
Primary Number of participants with SNPs variation of monoamine oxidase SNPs will be analyzed with Sanger based genotyping or equivalent method Time zero equals baseline
Primary Number of participants with SNPs variation of dopamine B hydroxylase SNPs will be analyzed with Sanger based genotyping or equivalent method Time zero equals baseline
Primary Number of participants with SNPs variation of dopamine receptor 3 SNPs will be analyzed with Sanger based genotyping or equivalent method Time zero equals baseline
Primary Number of participants with SNPs variation of brain-derived neurotropic factor genes SNPs will be analyzed with Sanger based genotyping or equivalent method Time zero equals baseline
Secondary Number of participants with SNPs variation of tryptophan hydroxylase-2 SNPs will be analyzed with Sanger based genotyping or equivalent method Time zero equals baseline
Secondary Number of participants with SNPs variation of 5-hydroxytryptamine transporter SNPs will be analyzed with Sanger based genotyping or equivalent method Time zero equals baseline
Secondary Number of participants with SNPs variation of 5-hydroxytryptamine receptor 2A SNPs will be analyzed with Sanger based genotyping or equivalent method Time zero equals baseline
Secondary Number of participants with SNPs variation of serotonin transporter gene-linked polymorphic region genes SNPs will be analyzed with Sanger based genotyping or equivalent method Time zero equals baseline
Secondary Number of participants with SNPs variation of opioid receptor gene SNPs will be analyzed with Sanger based genotyping or equivalent method Time zero equals baseline
Secondary Number of participants with SNPs variation of fatty acid amid hydrolase gene SNPs will be analyzed with Sanger based genotyping or equivalent method Time zero equals baseline
Secondary Assessment of Cronbach alpha of the personality questionnaire used in this study and the former ones Cronbach's alpha between 0 and 1 Time zero equals baseline
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