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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Smerud Medical Research International AS.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
SantoSolve AS
Information provided by:
Smerud Medical Research International AS
ClinicalTrials.gov Identifier:
NCT00954629
First received: August 6, 2009
Last updated: March 22, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Pain
Osteoarthritis
Drug: strontium chloride hexahydrate
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Smerud Medical Research International AS:

Primary Outcome Measures:
  • 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. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • WOMAC Osteoarthritis Index LK 3.1; total and non-pain subscales: [ Time Frame: At Screening, Baseline, Weeks 2, 4, 12, 26 and 27. ] [ Designated as safety issue: No ]
  • Pain intensity will be assessed by asking the question 'What is the level of pain in your target knee right now? [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: At weeks 12 and 26 ] [ Designated as safety issue: No ]
  • Clinician Global Impression of Change (CGIC) [ Time Frame: At weeks 12 and 26 ] [ Designated as safety issue: No ]
  • Use of rescue medication: The number of paracetamol tablets used each day will be recorded. [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: At weeks 2, 4, 12, 26, and 27 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: June 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2PX
Pain medication
Drug: strontium chloride hexahydrate
Topical solution to be applied twice daily for 26 weeks. Dosage of up till 4 ml per application.
Placebo Comparator: Placebo Drug: Placebo
Topical solution to be applied twice daily for 26 weeks. Dosage up till 4ml per application.

Detailed 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954629

Contacts
Contact: Robert Macnair, PhD +44 1357 523481 bob.macnair@smerud.com

Locations
Finland
Site in Helsinki Completed
Helsinki, Finland
Site at Kuopio Completed
Kuopio, Finland
Site in Turku Completed
Turku, Finland
Poland
Site in Bialystok Completed
Bialystok, Poland
Site in Kraków Completed
Kraków, Poland
Site in Warszawa Completed
Warszawa, Poland
Russian Federation
Site in St-Petersburg Completed
St-Petersburg, Russian Federation
Site in St-Petersburg Recruiting
St-Petersburg, Russian Federation
United Kingdom
Site in Blackpool Completed
Blackpool, United Kingdom
Site in Bolton Completed
Bolton, United Kingdom
Site in Bradford Completed
Bradford, United Kingdom
Site in Manchester Completed
Manchester, United Kingdom
Site at Heaton Moor Completed
Stockport, United Kingdom
Site at Heald Green Completed
Stockport, United Kingdom
Site at Cheadle Hulme Completed
Stockport, United Kingdom
Sponsors and Collaborators
Smerud Medical Research International AS
SantoSolve AS
Investigators
Principal Investigator: Stuart Ratcliffe, MD MAC Neuroscience centre in Blackpool, United Kingdom
  More Information

No publications provided

Responsible Party: Thorfinn Ege, SantoSolve AS
ClinicalTrials.gov Identifier: NCT00954629     History of Changes
Other Study ID Numbers: 2PX-OA-03
Study First Received: August 6, 2009
Last Updated: March 22, 2010
Health Authority: Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics
Norway: Directorate for Health
Finland: The National Advisory Board on Health Care Ethics
Finland: Finnish Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ethics Committee
Russia: National Ethic Committee
Russia: FSI Scientific Center of Expertise of Means for Medical Application at Roszdravnadzor
Russia: Federal Service on Surveillance in Healthcare and Social Development of Russian Federation

Keywords provided by Smerud Medical Research International AS:
Osteoarthritis
Pain
Knee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 20, 2014