PainPhase 3NCT00954629
A Study of the Efficacy and Safety of 2PX in Patients With Pain Due to Osteoarthritis of the Knee
A Phase 3 study testing strontium chloride hexahydrate in people with Pain and Osteoarthritis, run by Smerud Medical Research International AS at 15 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pain, Osteoarthritis
- What is being tested?
- strontium chloride hexahydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 15 sitesin 4 countries
- Study dates
- Jun 2009to May 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
United Kingdom7 sites
- Completed
Site in Blackpool
Blackpool
- Completed
Site in Bolton
Bolton
- Completed
Site in Bradford
Bradford
- Completed
Site in Manchester
Manchester
- Completed
Site at Cheadle Hulme
Stockport
- Completed
Site at Heald Green
Stockport
- Completed
Site at Heaton Moor
Stockport
Finland3 sites
- Completed
Site in Helsinki
Helsinki
- Completed
Site at Kuopio
Kuopio
- Completed
Site in Turku
Turku
Poland3 sites
- Completed
Site in Bialystok
Bialystok
- Completed
Site in Kraków
Krakow
- Completed
Site in Warszawa
Warsaw
Russia2 sites, 1 recruiting
- Completed
Site in St-Petersburg
Saint Petersburg
- Recruiting
Site in St-Petersburg
Saint Petersburg
About this study
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
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.
Read the 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.
- Conditions
- Pain, Osteoarthritis
- Being tested
- strontium chloride hexahydrate, Placebo
- Keywords
- Osteoarthritis, Pain, Knee
- Medical subject headings
- Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strontium chloride hexahydrateDrug
Topical solution to be applied twice daily for 26 weeks. Dosage of up till 4 ml per application.
PlaceboDrug
Topical solution to be applied twice daily for 26 weeks. Dosage up till 4ml per application.
| Study group | Role | What they receive |
|---|---|---|
| 2PX | Experimental | Pain medication Receives: Drug: strontium chloride hexahydrate |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 26 weeks
Secondary outcomes (6)
WOMAC Osteoarthritis Index LK 3.1; total and non-pain subscales:
Measured: 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?
Measured: Daily
Patient Global Impression of Change (PGIC)
Measured: At weeks 12 and 26
Clinician Global Impression of Change (CGIC)
Measured: At weeks 12 and 26
Use of rescue medication: The number of paracetamol tablets used each day will be recorded.
Measured: Daily
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.
Measured: At weeks 2, 4, 12, 26, and 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2010 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smerud Medical Research International AS
- Sponsor type
- University, hospital or other
- Collaborators
- SantoSolve AS
- Investigators
- Stuart Ratcliffe, MD, Principal investigator, MAC Neuroscience centre in Blackpool, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954629
- Sponsor's protocol ID
- 2PX-OA-03
- Status last verified
- Mar 2010
- First submitted
- 6 Aug 2009
- Last updated
- 24 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00954629
- Acronym / sponsor ID
- 2PX-OA-03
- Conditions
- Pain, Osteoarthritis
- Keywords
- Osteoarthritis, Pain, Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Smerud Medical Research International ASUniversity, hospital or other
- Collaborators
- SantoSolve AS
- Study start
- Jun 2009
- Primary completion
- May 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 7 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2PX | Experimental | Drug: strontium chloride hexahydratePain medication |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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:
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| strontium chloride hexahydrateTopical solution to be applied twice daily for 26 weeks. Dosage of up till 4 ml per application. | Drug | 2PX |
| PlaceboTopical solution to be applied twice daily for 26 weeks. Dosage up till 4ml per application. | Drug | Placebo |
Primary outcome
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
6 secondary outcomes
WOMAC Osteoarthritis Index LK 3.1; total and non-pain subscales:
Time frame: 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?
Time frame: Daily
Patient Global Impression of Change (PGIC)
Time frame: At weeks 12 and 26
Clinician Global Impression of Change (CGIC)
Time frame: At weeks 12 and 26
Use of rescue medication: The number of paracetamol tablets used each day will be recorded.
Time frame: Daily
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Ratcliffe, MD principal investigator
MAC Neuroscience centre in Blackpool, United Kingdom
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing strontium chloride hexahydrate in people with Pain and Osteoarthritis, run by Smerud Medical Research International AS at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom, Finland, Poland, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Macnair, PhD (+44 1357 523481, bob.macnair@smerud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2010.