Study With Chondroitin Sulfate and Glucosamine Sulfate (in Dosage Capsule and Sachet) in Treating Osteoarthritis
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ClinicalTrials.gov Identifier: NCT01293305 |
Recruitment Status
: Unknown
Verified January 2011 by Azidus Brasil.
Recruitment status was: Not yet recruiting
First Posted
: February 10, 2011
Last Update Posted
: February 10, 2011
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Tracking Information | |||
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First Submitted Date ICMJE | February 8, 2011 | ||
First Posted Date ICMJE | February 10, 2011 | ||
Last Update Posted Date | February 10, 2011 | ||
Study Start Date ICMJE | November 2011 | ||
Estimated Primary Completion Date | August 2012 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Promotion of pain relief in patients with osteoarthritis. [ Time Frame: 4 months. ] Assessment of noninferiority clinical association Chondroitin + glucosamine in dosage forms and oral powder hard gelatin capsule, produced by Geolab Pharmaceutical Ltd., with the comparator drugs in the same dosage forms produced by the Laboratory Zodiac (Condroflex ®) through the promotion of pain relief in patients with osteoarthritis between grades 1 and 3, according to the classification of Kellgreen & Lawrence (1957), measured by visual analogue scale (VAS). There will be five visits: V0, V1, V2, V3 and V4.
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Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | No Changes Posted | ||
Current Secondary Outcome Measures ICMJE |
Functional capacity, overall assessment of clinical improvement, assessment of adverse events [ Time Frame: 4 months. ] Are the secondary objectives:
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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 | Study With Chondroitin Sulfate and Glucosamine Sulfate (in Dosage Capsule and Sachet) in Treating Osteoarthritis | ||
Official Title ICMJE | Randomized Evaluation Of Not Less Medical Association Chondroitin Sulfate Plus Glucosamine Sulfate (In Powder Dosage Forms And Oral Capsule), Manufactured By The Geolab Pharmaceutical Industry Ltd, Compared To The Drug Condroflex® (Powder And Oral Capsule), Manufactured In The Laboratory Zodiac, The Treatment Of Osteoarthritis. | ||
Brief Summary | The use of chondroitin sulfate and glucosamine sulfate has been recognized since the 70 decade in the treatment of osteoarthritis. Numerous clinical trials have demonstrated the therapeutic properties of this association in control of osteoarthritis, especially in reducing pain and improving movement. The combination of chondroitin sulfate with glucosamine sulfate offers a significantly higher tolerance than most drug treatments and, moreover, has long lasting effects even after stopping treatment. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Osteoarthritis | ||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||
* 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 | Unknown status | ||
Estimated Enrollment ICMJE |
320 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Estimated Study Completion Date | December 2012 | ||
Estimated Primary Completion Date | August 2012 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Constitute the criteria for inclusion in the study:
Constitute the criteria for exclusion from the study:
Use of corticosteroids orally or intramuscularly, fast action, for up to two weeks before V-1 or 14 days before the scheduled visits Use of oral corticosteroids or intramuscular depot for up to 4 weeks before V-1 or 14 days before the scheduled visits the administration of intra-articular corticosteroids in the study joint in the 3 months prior to randomization visit (V0) or during the study the administration of intra-articular corticosteroid into any other joint for up to 4 weeks prior to randomization visit (V0) or during the study
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Sex/Gender |
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Ages | 40 Years and older (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Not Provided | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01293305 | ||
Other Study ID Numbers ICMJE | CGSGEO1010 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Dr. Sergio Marcolino Rosa, LAL Clinica Pesquisa e Desenvolvimento Ltda. | ||
Study Sponsor ICMJE | Azidus Brasil | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Azidus Brasil | ||
Verification Date | January 2011 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |