Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452101
Status:
COMPLETED
Last Update Posted:
2007-03-26
First Post:
2007-03-22
Brief Title:
Effects of Aquamin F on Osteoarthritis of the Knee
Sponsor:
Marigot Ltd
Organization:
Marigot Ltd
Study Overview
Official Title:
Randomized Placebo Controlled Trial Effects of Aquamin F Alone or in Combination With Glucosamine Sulfate on Joint Mobility and Pain in Osteoarthritis of the Knee
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this trial is to evaluate the effect of Aquamin F alone or in combination with glucosamine sulfate versus placebo on symptoms of joint pain stiffness and immobility in subjects with painful osteoarthritis of the knee The following hypotheses were tested
Hypothesis 1 After 12 weeks of treatment subjects taking Aquamin F alone or in combination with glucosamine sulfate will have significantly less joint pain stiffness and immobility compared to subjects taking glucosamine sulfate alone or placebo alone
Hypothesis 2 No significant differences will be seen for adverse events between the subjects taking Aquamin F glucosamine sulfate Aquamin F glucosamine sulfate or placebo
Hypothesis 1 After 12 weeks of treatment subjects taking Aquamin F alone or in combination with glucosamine sulfate will have significantly less joint pain stiffness and immobility compared to subjects taking glucosamine sulfate alone or placebo alone
Hypothesis 2 No significant differences will be seen for adverse events between the subjects taking Aquamin F glucosamine sulfate Aquamin F glucosamine sulfate or placebo
Detailed Description:
Method Subjects were randomized to receive 12 weeks of Glucosamine sulfate vs Aquamin F vs Placebo vs Aquamin F Glucosamine sulfate while controlling for pain with acetaminophen Subjects were then followed for blood chemistry measurements only over an additional 12-week period specifically to assess blood calcium levels post treatment All participants were subjected to the same diet and exercise regimen and measurements included WOMAC scores pain stiffness mobility total score 6 Minute Walking Distances active and passive range of motion measurements DXA scans blood chemistry hematology CRP levels and lipid profiles as well as rescue medication diary measurements and adverse event assessments An independent statistician analyzed the data using independent t-tests and ANCOVA for between-group comparisons and matched-pair t-tests for within-group comparisons of patients included in ITT-LOCF and completer analyses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None