Measurement of Substance P in Saliva of Low Back Pain Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Kovacs Foundation.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Kovacs Foundation
Information provided by:
Kovacs Foundation
ClinicalTrials.gov Identifier:
NCT00735735
First received: August 14, 2008
Last updated: June 26, 2011
Last verified: December 2009
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | August 14, 2008 | ||||||||
| Last Updated Date | June 26, 2011 | ||||||||
| Start Date ICMJE | February 2009 | ||||||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Levels of Substance P in the saliva [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Higher levels of Substance P in the saliva of subjects with severe chronic low back pain. [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT00735735 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Measurement of Substance P in Saliva of Low Back Pain Patients | ||||||||
| Official Title ICMJE | Study of the Measurement of Substance P in the Saliva of Patients With Low Back Pain | ||||||||
| Brief Summary | The purpose of this study is to compare the levels of Substance P in saliva, in patients with severe chronic low back pain and in subjects without it. In addition, to explore a possible cutoff point, in order to define normal and pathological levels of Substance P in saliva. The ultimate objective would be to design a measurement method for use in routine clinical practice. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Diagnostic |
||||||||
| Condition ICMJE | Low Back Pain | ||||||||
| Intervention ICMJE | Other: The taking of a saliva sample from each subject.
After taking the sample, the saliva will be transferred via a pipette to a clean tube which will be labeled with the subject's name, the date and the hour. Once a month the tubes will be sent to the collaborating laboratory for analysis. |
||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | June 2012 | ||||||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
For healthy subjects:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Spain | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00735735 | ||||||||
| Other Study ID Numbers ICMJE | FK 26 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation | ||||||||
| Study Sponsor ICMJE | Kovacs Foundation | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Kovacs Foundation | ||||||||
| Verification Date | December 2009 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||