A Study of the Efficacy and Safety of 2PX in Patients With Pain Due to Osteoarthritis of the Knee

Pain Clinical Trial

Official title:

A 26 Week Placebo-controlled, Randomised, Double-blind, Parallel Group Study of the Efficacy and Safety of 2PX (Topical Strontium Chloride Hexahydrate) in Patients With Pain Due to Osteoarthritis of the Knee

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00954629
• Other study ID #: 2PX-OA-03
• Status: Recruiting
• Phase: Phase 3
• First received: August 6, 2009
• Last updated: March 22, 2010
• Start date: June 2009
• Est. completion date: May 2010

Study information

• Verified date: March 2010
• Source: Smerud Medical Research International AS
• Contact: Robert Macnair, PhD
• Phone: +44 1357 523481
• Email: bob.macnair[@]smerud.com
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway:National Committee for Medical and Health Research EthicsNorway: Directorate for HealthFinland: The National Advisory Board on Health Care EthicsFinland: Finnish Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPoland: Ethics CommitteeRussia: National Ethic CommitteeRussia: FSI Scientific Center of Expertise of Means for Medical Application at RoszdravnadzorRussia: Federal Service on Surveillance in Healthcare and Social Development of Russian Federation
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to demonstrate the superiority of topically administered 2PX versus placebo (vehicle) control in terms of reduction in pain intensity and physical function.

Description:

Primary objective: To demonstrate the superiority of topically administered 2PX versus placebo (vehicle) control in terms of reduction in pain intensity and physical function.

Secondary objectives: To prospectively measure other efficacy variables of topically administered 2PX in pain associated with osteoarthritis of the knee. To evaluate the safety and tolerability of topically administered 2PX.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Male and female out-patients, 40 years or older.

• Subjects with documented OA of either one or both knees, as defined by the American College of Rheumatology (ACR) criteria ([Altman R, Asch E, Bloch D, et al (1986)]); i.e.knee pain and at least 3 out of the following 6 criteria in the target joint:

• age >50 years

• stiffness < 30 minutes

• crepitus

• bony tenderness

• bony enlargement

• no palpable warmth

• Radiological evidence of joint space narrowing in the target joint within 8 weeks prior to randomisation.

• Subjects with chronic, moderate to severe OA pain of the target knee:

• present for more than 3 months, and for = 20 days per month.

• not controlled by, or intolerant of, oral NSAIDs, paracetamol, COX-2 inhibitors or weak opioids.

• intensity at least moderate (i.e., actual WOMAC (pain questions 1-5) = 10) on WOMAC OA index LK 3.1 at Visit 1, in the target knee, as recalled over the last 24 hours.

Exclusion Criteria:

• Subjects with any moderate to severe pain of other origin (e.g., fibromyalgia) which could confound assessment or self-evaluation of pain due to OA in the target knee.

• Subjects with any prosthesis fitted to the target knee.

• Subjects requiring treatment with any of the following agents/therapies within the specified periods or at any time during the study are excluded from participation:

• Any potent/strong opioid in the 4 weeks prior to randomisation (i.e., an opioid assumed to cause withdrawal symptoms upon abrupt discontinuation).

• Any topical or subcutaneously applied analgesic agents (e.g., capsaicin, NSAIDs) applied to the target knee within 7 days prior to randomisation.

• Any treatment which could alter the degree or nature of baseline OA pain planned within the study period.

• Intra-articular injections of corticosteroids in the target knee within the 2 months prior to randomisation.

• Intra-articular injections of hyaluronan in the target knee within 6 months prior to randomisation.

• Avascular necrosis in the target knee within 6 months prior to randomisation.

• Arthrosynthesis of the target knee within 12 months prior to randomisation.

• Arthroscopy of the target knee within 6 months prior to randomisation.

• Major trauma to the target knee within 6 months prior to randomisation.

• Infection in the target knee within 6 months prior to randomisation.

• Subjects who have previously been treated with 2PX.

• Subjects who have received an investigational drug or used an investigational device within the 30 days prior to randomisation.

• Subjects with a significant psychiatric disorder, in the opinion of the investigator, or subjects receiving strong anti-psychotic medication.

• Subjects with documented or suspected alcohol or drug abuse.

• Any ongoing or past history of malignant disease within the 5 years immediately prior to randomisation (with the exception of basal cell carcinoma).

• Pregnancy or ongoing lactation

• Female subjects of childbearing potential unwilling to use adequate contraceptive measures throughout the duration of the study. For the purpose of this study, adequate contraception is defined as:

• oral, injected or implanted hormonal methods of contraception; OR

• placement of an intrauterine device (IUD) or intrauterine system (IUS); OR

• barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository Note: Male sterilisation or abstinence are not acceptable methods of birth control and would preclude enrolment in the study.

Note: For post-menopausal women: less than 12 months since the last spontaneous menstrual bleeding will exclude the patient unless they are willing to utilise acceptable methods of contraception for the duration of the study.

• Male subjects able to conceive, who are unwilling to use barrier methods of contraception throughout the duration of the study

• Subjects unable to comply with the study assessments.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Pain

Intervention

Drug:
• strontium chloride hexahydrate
Topical solution to be applied twice daily for 26 weeks. Dosage of up till 4 ml per application.
• Placebo
Topical solution to be applied twice daily for 26 weeks. Dosage up till 4ml per application.

Locations

Country	Name	City	State
Finland	Site in Helsinki	Helsinki
Finland	Site at Kuopio	Kuopio
Finland	Site in Turku	Turku
Poland	Site in Bialystok	Bialystok
Poland	Site in Kraków	Kraków
Poland	Site in Warszawa	Warszawa
Russian Federation	Site in St-Petersburg	St-Petersburg
Russian Federation	Site in St-Petersburg	St-Petersburg
United Kingdom	Site in Blackpool	Blackpool
United Kingdom	Site in Bolton	Bolton
United Kingdom	Site in Bradford	Bradford
United Kingdom	Site in Manchester	Manchester
United Kingdom	Site at Cheadle Hulme	Stockport
United Kingdom	Site at Heald Green	Stockport
United Kingdom	Site at Heaton Moor	Stockport

Sponsors (2)

Lead Sponsor	Collaborator
Smerud Medical Research International AS	SantoSolve AS

Countries where clinical trial is conducted

Finland,  Poland,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference between the active and placebo group in the change from Baseline to the assessment after 26 weeks of treatment in the actual WOMAC Osteoarthritis Index LK 3.1 subscale score for pain and physical function.		26 weeks	No
Secondary	WOMAC Osteoarthritis Index LK 3.1; total and non-pain subscales:		At Screening, Baseline, Weeks 2, 4, 12, 26 and 27.	No
Secondary	Pain intensity will be assessed by asking the question 'What is the level of pain in your target knee right now?		Daily	No
Secondary	Patient Global Impression of Change (PGIC)		At weeks 12 and 26	No
Secondary	Clinician Global Impression of Change (CGIC)		At weeks 12 and 26	No
Secondary	Use of rescue medication: The number of paracetamol tablets used each day will be recorded.		Daily	No
Secondary	Incidence of Disease Flares: The number and extent of flares in osteoarthritis pain of the target knee between active and placebo groups during the course of treatment.		At weeks 2, 4, 12, 26, and 27	No