Knee OsteoarthritisPhase 1NCT02139319
Dose-Escalation of Botulinum Toxin in Subjects With Osteoarthritis of the Knee
A Phase 1 study testing Botulinum toxin in people with Knee Osteoarthritis, run by Galderma R&D at 1 site in United Kingdom.
Trial summary
The purpose of the study is to evaluate the safety and tolerability of the drug product at each dose level. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Botulinum toxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Jul 2014
- Phase
- Phase 1
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis of the knee
- Fully weight bearing in the index knee with or without the need for assistive/orthopaedic devices
- Pain score ≥40 mm of the index knee
- Committing to continue using their assistive/orthopaedic device throughout the study using the same regimen
Who cannot join
- Any infection in the index knee or inflammatory skin disease or other inflammatory diseases at the index knee or the anticipated injection site
- Surgery on the symptomatic knee within the previous 12 months or arthroscopy in the index knee in the past 3 months
- Any painful orthopaedic disorder of the back or hip which is likely to interfere with the safety or efficacy assessments
- A joint disorder other than osteoarthritis in the index knee which could potentially interfere with the safety or efficacy assessments
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to evaluate the safety and tolerability of the drug product at each dose level.
- Conditions
- Knee Osteoarthritis
- Being tested
- Botulinum toxin, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin | Experimental | Single intra-articular injection Receives: Drug: Botulinum toxin |
| Placebo | Placebo comparator | Single intra-articular injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Q-Med AB, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139319
- Sponsor's protocol ID
- 43QM1309
- Status last verified
- Aug 2014
- First submitted
- 13 May 2014
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Escalation of Botulinum Toxin in Subjects With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02139319
- Acronym / sponsor ID
- 43QM1309
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 May 2014 (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 evaluate the safety and tolerability of the drug product at each dose level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin | Experimental | Drug: Botulinum toxinSingle intra-articular injection |
| Placebo | Placebo comparator | Drug: PlaceboSingle intra-articular injection |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Osteoarthritis of the knee
- Fully weight bearing in the index knee with or without the need for assistive/orthopaedic devices
- Pain score ≥40 mm of the index knee
- Committing to continue using their assistive/orthopaedic device throughout the study using the same regimen
Key exclusion criteria (4 listed)
- Any infection in the index knee or inflammatory skin disease or other inflammatory diseases at the index knee or the anticipated injection site
- Surgery on the symptomatic knee within the previous 12 months or arthroscopy in the index knee in the past 3 months
- Any painful orthopaedic disorder of the back or hip which is likely to interfere with the safety or efficacy assessments
- A joint disorder other than osteoarthritis in the index knee which could potentially interfere with the safety or efficacy assessments
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 |
|---|---|---|
| Botulinum toxin | Drug | Botulinum toxin |
| Placebo | Drug | Placebo |
Primary outcome
Incidence and severity of adverse events
Time frame: Up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
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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.
Q-Med AB study director
Galderma R&D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Botulinum toxin in people with Knee Osteoarthritis, run by Galderma R&D at 1 site in United Kingdom.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (time frame: Up to 6 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 25 Aug 2022.