Topical treatment of hand osteoarthritis with glucosamine cream.

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-004885-33-BE
• Date of registration: 24/06/2008
• Prospective Registration: Yes
• Primary sponsor: Bio Minerals n.v.
• Public title: Topical treatment of hand osteoarthritis with glucosamine cream.
• Scientific title: Topical treatment of hand osteoarthritis with glucosamine cream.
• Date of first enrolment: 29/07/2008
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-004885-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Belgium

Key inclusion & exclusion criteria

Inclusion criteria:
- Patients of either sex
- Age > 30 years
- Providing of written informed consent.
- Patients with hand osteoarthritis according to the diagnostic criteria of the American College of Rheumatology
- Patients with primary (non-erosive and erosive OA) and post-traumatic (due only to remote [> 6 months ago] trauma).
- Patients with thumb OA
- On entry, a global hand pain score in the target hand of at least 40 mm on a 100 mm visual analogue scale (VAS), after withdrawal of other analgesic/anti-inflammatory medications.
- Patients who are taking paracetamol (as rescue medication) are allowed to participate in the trial.
- Minimum symptom duration: pain should have been present for at least half of the days in the previous month (i.e. pain should have been present for at least 15 days in the previous month) and for at least 48 hours prior to inclusion visit (T0).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Patient unable to understand the study procedures and/or not having given written informed consent and/or not wishing to participate in one of the subsequent therapeutic intervention protocols.
- Unlikely to co-operate fully in the study.
- Alcohol (e.g. more than 28 units per week) or drug abuse.
- Pregnancy or breastfeeding women.
- Patients with a swollen or warm joint thought to be secondary to gout, pseudogout or sepsis.
- Clinically significant medical abnormalities, which would make the patient unsuitable for the study as judged by the investigator.
- The patient has a fracture or malignant tumor at the hands. Significant injury to the affected joint within 6 months of trial start. Disease upper extremity joints of sufficient degree to affect assessment of the target joint. Presence of OA secondary to known disorders other that remote (> 6 months ago) trauma.
- Poor general health interfering with compliance or assessment
- Less than 1 month between the time of IA injection of depocorticosteroid and enrollment.
- Less than 6 months between the time of IA injection of a hyaluronate and enrollment.
- Patients with symptomatic knee OA.
- Use of assistive devices such as a cane or crutch.
- Less than 3 months between the treatment with a slow acting drug for symptom relief and enrollment
- Concomitant and previous medication:
? Use (topical, systemic, intra-articular) of hyaluronic acid, glucosamine sulphate, glucosamine HCl, n-acetyl glucosamine and derivatives thereof such as chondroitin sulphate, glycosaminoglycans.
? Patients who have used previous topical and/or systemic treatment with NSAID’s or analgetica, different from paracetamol, such as ibuprofen, diclofenac, acetyl salicylic acid, piroxicam and indomethacin in a 14 days period prior to the start of the study
? Patients who have used medications with MMP-inhibitory properties (e.g. tetracyclines or structurally related compounds), or took oral (systemic, > 10 days duration) glucocorticoids in a 28 days period prior to start of the study.
? Patients who have used compounds containing agents claiming to possess disease/structure modifying properties (e.g. diacerhein, glucosamine and/or chondroitin sulfate containing compounds) in a 28 days period prior to start of the study.
- Treatment during the trial with physical and/or occupational therapy.
- Known allergy against glucosamine or any of the ingredients in the cream.
- Open wounds at the hands.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

osteoarthritis of the hands

Intervention(s)

Product Name: WinFlex cream
Product Code: 0904-277
Pharmaceutical Form: Cream
INN or Proposed INN: glucosamine sulphate
CAS Number: 3416-24-8
Current Sponsor code: 0903-264
Other descriptive name: glucosamine sulphate potassium chloride
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Cream
Route of administration of the placebo: Topical use (Noncurrent)

Primary Outcome(s)

Primary end point(s): The primary outcome measure is:
The global pain intensity in the target hand measured on a 100 mm VAS, respectively after 2 and 4 weeks treatment.

Main Objective: To assess the global pain intensity in the target hand measured on a 100 mm VAS, respectively after 2 and 4 weeks treatment.

Secondary Objective: The secondary outcome measures are:
? The response to treatment, defined by the OARSI (OsteoArthritis Research Society International) and the OMERACT (Outcome Measures in Rheumatology) committees
? The change in the AUSCAN pain subscale from baseline to respectively 2 and 4 weeks treatment.
? The response to treatment, defined as 30% decrease in the AUSCAN pain subscale from baseline to 2 and 4 weeks.
? The change in AUSCAN joint stiffness, and physical function subscales from baseline to respectively 2 and 4 weeks treatment.
? The change in palpation pain evaluated by the Ritchie scale for the target hand from baseline to respectively 2 and 4 weeks treatment.
? The change in grip strength measured by dynamometry for the target hand from baseline to respectively 2 and 4 weeks treatment.
? The use of paracetamol as rescue medication measured by checking compliance, from baseline to respectively 2 and 4 weeks treatment

Secondary ID(s)

04/4