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

NCT00954629 | Unknown Phase 3

• 1 other identifier: 2PX-OA-03
• Study Type: interventional
• Target: 300
• Locations: 4 countries
• Sites: 15

Brief 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.

Conditions

Pain; Osteoarthritis

Keywords

Osteoarthritis; Pain; Knee

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• WOMAC Osteoarthritis Index LK 3.1; total and non-pain subscales:

  At Screening, Baseline, Weeks 2, 4, 12, 26 and 27.

• Pain intensity will be assessed by asking the question 'What is the level of pain in your target knee right now?

  Daily

• Patient Global Impression of Change (PGIC)

  At weeks 12 and 26

• Clinician Global Impression of Change (CGIC)

  At weeks 12 and 26

• Use of rescue medication: The number of paracetamol tablets used each day will be recorded.

  Daily

Study Arms (2)

2PX

EXPERIMENTAL

Pain medication

Drug: strontium chloride hexahydrate

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

strontium chloride hexahydrate DRUG

Topical solution to be applied twice daily for 26 weeks. Dosage of up till 4 ml per application.

2PX

Placebo DRUG

Topical solution to be applied twice daily for 26 weeks. Dosage up till 4ml per application.

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smerud Medical Research International AS: lead
• SantoSolve AS: collaborator

Study Sites (15)

Site in Helsinki

Helsinki, Finland

COMPLETED

Site at Kuopio

Kuopio, Finland

COMPLETED

Site in Turku

Turku, Finland

COMPLETED

Site in Bialystok

Bialystok, Poland

COMPLETED

Site in Kraków

Krakow, Poland

COMPLETED

Site in Warszawa

Warsaw, Poland

COMPLETED

Site in St-Petersburg

Saint Petersburg, Russia

COMPLETED

Site in St-Petersburg

Saint Petersburg, Russia

RECRUITING

Site in Blackpool

Blackpool, United Kingdom

COMPLETED

Site in Bolton

Bolton, United Kingdom

COMPLETED

Site in Bradford

Bradford, United Kingdom

COMPLETED

Site in Manchester

Manchester, United Kingdom

COMPLETED

Site at Cheadle Hulme

Stockport, United Kingdom

COMPLETED

Site at Heald Green

Stockport, United Kingdom

COMPLETED

Site at Heaton Moor

Stockport, United Kingdom

COMPLETED

MeSH Terms

Conditions

Pain; Osteoarthritis

Interventions

strontium chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Stuart Ratcliffe, MD

  MAC Neuroscience centre in Blackpool, United Kingdom

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Macnair, PhD

CONTACT

+44 1357 523481; bob.macnair@smerud.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 6, 2009
• First Posted: August 7, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: March 24, 2010

Record last verified: 2010-03

Locations

FI (3); PL (3); GB (7); RU (2)