Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110474
Status:
COMPLETED
Last Update Posted:
2006-09-19
First Post:
2005-05-09
Brief Title:
Glucosamine Unum In Die Once A Day Efficacy GUIDE Trial Glucosamine Sulfate in Patients With Knee Osteoarthritis
Sponsor:
Rottapharm
Organization:
Rottapharm
Study Overview
Official Title:
Efficacy and Safety of Glucosamine Sulfate Versus a Pure Analgesic AcetaminophenParacetamol and Placebo in Patients Suffering From Osteoarthritis of the Knee
Status:
COMPLETED
Status Verified Date:
2006-09
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 primary objective of this study is to evaluate the efficacy and safety of glucosamine sulfate versus placebo on the symptoms of knee osteoarthritis after 6 months of treatment using acetaminophen as a reference symptomatic medication
Detailed Description:
Osteoarthritis is a common degenerative joint disease affecting a large proportion of the general population Its severity is progressive and often requires long-term treatment courses
Medications for osteoarthritis may affect symptoms pain and function limitation andor modify joint structure
Pharmacological agents usually employed to treat symptoms generally include unspecific drugs such as pure analgesics and non-steroidal antiinflammatory drugs NSAIDs as well as compounds that are possibly disease specific since they probably interact with some of the osteoarthritis pathogenetic factors glucosamine sulfate is one of these agents
Glucosamine sulfate has recently attracted the attention of the scientific community and of patients because two long-term 3 years clinical trials in comparison with placebo showed that this is the first agent able to retard the progression of anatomic joint structure changes in knee osteoarthritis besides controlling the progression of symptoms
Earlier studies had shown that glucosamine sulfate is effective in relieving the symptoms of osteoarthritis also over shorter treatment courses few weeks or months in comparison with placebo In addition glucosamine sulfate efficacy in short studies was at least comparable to that of unspecific symptomatic medications such as conventional NSAIDs whilst being better tolerated However all practice guidelines for the treatment of osteoarthritis suggest acetaminophen paracetamol as the oral analgesic to try first and if successful the preferred long-term symptomatic medication
This trial was therefore designed to confirm the efficacy of glucosamine sulfate in comparison with placebo and to assess its relative value compared with acetaminophen In fact superiority of a well tolerated drug such as glucosamine sulfate and with the long-term treatment potential shown in other trials may represent a major therapeutic advantage
The treatment has a duration of 6 months that is believed to be the minimum length to assess the effects of a symptomatic medication in osteoarthritis
The study is performed according to a multicenter randomised placebo- and reference-controlled double-blind double-dummy parallel group prospective design
The sample size has been calculated on the basis of the expected efficacy of the test drug on the primary outcome Lequesne index
Following a screening visit and a short baseline period to check adherence to the inclusionexclusion criteria a total of at least 300 patients with knee osteoarthritis are randomised to receive either oral glucosamine sulfate soluble powder 1500 mg once-a-day or acetaminophen tablets 1000 mg three times a day total 3gday as recommended in Europe or placebo for 6 months The rescue medication for flare episodes consists of the standardized use according to specific instructions given to the patients of ibuprofen 400 mg tablets whose consumption is recorded in a patient daily diary
The primary efficacy outcome measure is represented by the change in the Lequesne algo-functional index assessed at clinic visits after 6 months in the intention-to treat population analysed by the General Linear Model GLM procedure for ANOVA with Dunnets pairwise comparisons versus placebo Efficacy in patients completing treatment according to the protocol per-protocol completers will be also assessed Secondary efficacy outcome measures include the changes in the WOMAC index and the calculation of the proportion of patients that can be defined responders to treatment according to the Osteoarthritis Research Society International OARSI criteria 2000 The use of the rescue medication is also assessed
Safety is assessed by reporting of adverse events and by routine laboratory tests
The glucosamine sulfate substance used in this trial crystalline glucosamine sulfate is a prescription drug in Europe and elsewhere mostly used in its 1500 mg powder for oral solution formulation to be administered once daily This is the substanceformulation that was effective and safe in the vast majority of glucosamine clinical trials including the long-term 3-year studies
Differently than in Europe and other countries glucosamine formulations are marketed in the United States as dietary supplements They include glucosamine sulfate substances different than the original prescription preparation other glucosamine salts mainly glucosamine hydrochloride and are administered according to different dosage schemes mainly as oral solid formulations that provide a total 1500 mg dose but divided in three daily intakes tid In clinical trials conducted so far these formulations failed to show the same efficacy of the original glucosamine sulfate prescription preparation
The present study uses therefore the original prescription crystalline glucosamine sulfate given once-a-day unum-in-die uid and it is therefore named the Glucosamine Unum In Die Efficacy GUIDE Trial
Medications for osteoarthritis may affect symptoms pain and function limitation andor modify joint structure
Pharmacological agents usually employed to treat symptoms generally include unspecific drugs such as pure analgesics and non-steroidal antiinflammatory drugs NSAIDs as well as compounds that are possibly disease specific since they probably interact with some of the osteoarthritis pathogenetic factors glucosamine sulfate is one of these agents
Glucosamine sulfate has recently attracted the attention of the scientific community and of patients because two long-term 3 years clinical trials in comparison with placebo showed that this is the first agent able to retard the progression of anatomic joint structure changes in knee osteoarthritis besides controlling the progression of symptoms
Earlier studies had shown that glucosamine sulfate is effective in relieving the symptoms of osteoarthritis also over shorter treatment courses few weeks or months in comparison with placebo In addition glucosamine sulfate efficacy in short studies was at least comparable to that of unspecific symptomatic medications such as conventional NSAIDs whilst being better tolerated However all practice guidelines for the treatment of osteoarthritis suggest acetaminophen paracetamol as the oral analgesic to try first and if successful the preferred long-term symptomatic medication
This trial was therefore designed to confirm the efficacy of glucosamine sulfate in comparison with placebo and to assess its relative value compared with acetaminophen In fact superiority of a well tolerated drug such as glucosamine sulfate and with the long-term treatment potential shown in other trials may represent a major therapeutic advantage
The treatment has a duration of 6 months that is believed to be the minimum length to assess the effects of a symptomatic medication in osteoarthritis
The study is performed according to a multicenter randomised placebo- and reference-controlled double-blind double-dummy parallel group prospective design
The sample size has been calculated on the basis of the expected efficacy of the test drug on the primary outcome Lequesne index
Following a screening visit and a short baseline period to check adherence to the inclusionexclusion criteria a total of at least 300 patients with knee osteoarthritis are randomised to receive either oral glucosamine sulfate soluble powder 1500 mg once-a-day or acetaminophen tablets 1000 mg three times a day total 3gday as recommended in Europe or placebo for 6 months The rescue medication for flare episodes consists of the standardized use according to specific instructions given to the patients of ibuprofen 400 mg tablets whose consumption is recorded in a patient daily diary
The primary efficacy outcome measure is represented by the change in the Lequesne algo-functional index assessed at clinic visits after 6 months in the intention-to treat population analysed by the General Linear Model GLM procedure for ANOVA with Dunnets pairwise comparisons versus placebo Efficacy in patients completing treatment according to the protocol per-protocol completers will be also assessed Secondary efficacy outcome measures include the changes in the WOMAC index and the calculation of the proportion of patients that can be defined responders to treatment according to the Osteoarthritis Research Society International OARSI criteria 2000 The use of the rescue medication is also assessed
Safety is assessed by reporting of adverse events and by routine laboratory tests
The glucosamine sulfate substance used in this trial crystalline glucosamine sulfate is a prescription drug in Europe and elsewhere mostly used in its 1500 mg powder for oral solution formulation to be administered once daily This is the substanceformulation that was effective and safe in the vast majority of glucosamine clinical trials including the long-term 3-year studies
Differently than in Europe and other countries glucosamine formulations are marketed in the United States as dietary supplements They include glucosamine sulfate substances different than the original prescription preparation other glucosamine salts mainly glucosamine hydrochloride and are administered according to different dosage schemes mainly as oral solid formulations that provide a total 1500 mg dose but divided in three daily intakes tid In clinical trials conducted so far these formulations failed to show the same efficacy of the original glucosamine sulfate prescription preparation
The present study uses therefore the original prescription crystalline glucosamine sulfate given once-a-day unum-in-die uid and it is therefore named the Glucosamine Unum In Die Efficacy GUIDE Trial
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