Hand OsteoarthritisPhase 4DUPRONCT02612233
Pain Management in Osteoarthritis Using the Centrally Acting Analgesics Duloxetine and Pregabalin
A Phase 4 study of Hand Osteoarthritis, run by St George's, University of London at 1 site in United Kingdom.
Trial summary
Osteoarthritis is the most common form of arthritis worldwide. Specifically, osteoarthritis of the hands affects millions of people and is a major cause of hand disability and pain. Despite this, there are currently no treatments that delay or halt the development of osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Osteoarthritis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Jul 2016
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of hand osteoarthritis
- Participants with hand osteoarthritis presenting to rheumatology outpatient clinics and primary care.
- Participants will be right or left handed
- Male or female
- Age between 40 and 75
- Participants will be on usual care for hand osteoarthritis including paracetamol and/or non-steroidal anti-inflammatory drugs
Who cannot join
- Participants with other rheumatological diagnoses e.g. rheumatoid arthritis
- Current or planned pregnancy
- Contraindications to duloxetine or pregabalin
- History of depression
- Recent surgery
- Previous use of duloxetine and/or pregabalin
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hotung Centre for Musculoskeletal Diseases
London, SW17 ORE
About this study
Osteoarthritis is the most common form of arthritis worldwide. Specifically, osteoarthritis of the hands affects millions of people and is a major cause of hand disability and pain. Despite this, there are currently no treatments that delay or halt the development of osteoarthritis. Pain is one of the major symptoms of osteoarthritis and pain management is an important factor to consider in the treatment of this condition. Treatments for pain in osteoarthritis consists of local injections, anti-inflammatory gels or painkillers such as paracetamol. However, most people with osteoarthritis still have pain despite these treatments.
Read the detailed description
Recent scientific studies have suggested that people with hand osteoarthritis not only feel pain in their hand joints, they also appear to have increased signals in their brain pain processing pathways. At St George's, University of London, the investigators have been conducting studies to find out which brain regions are activated in subjects with hand osteoarthritis. The investigators have found that certain brain regions (thalamus, insula, cingulate and somatosensory cortex) are activated during painful tasks in patients with hand osteoarthritis but not in healthy people. In this study the investigators will establish whether drugs that inhibit pain processing pathways in the brain can help. Patients who are still having pain despite their usual painkillers will be randomly divided into 3 groups: one group will receive a placebo, the other 2 groups will receive one of two different drugs, duloxetine or pregabalin. Participants will be assessed using questionnaires and a brain scan (functional MRI) before and after 13 weeks of taking the tablets. This study will help us to understand the ways in which people feel pain in osteoarthritis. If our trial proves successful,drugs that dampen central pain pathways could be used in combination with local pain-relieving drugs to improve treatment and reduce disability in patients with hand osteoarthritis.
- Conditions
- Hand Osteoarthritis
- Being tested
- Pregabalin or Duloxetine or Placebo
- Keywords
- Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin or Duloxetine or PlaceboDrug
Also called DUPRO Capsules
This is a randomized, double blind placebo controlled trial with a head-to-head comparison of duloxetine vs pregabalin vs placebo over-encapsulated to prevent unblinding of treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Active comparator | Pregabalin 150mg ON week 1 increased to Pregabalin 300mg ON weeks 2-11 then decrease to Pregabalin 150mg ON week 12 then STOP Receives: Drug: Pregabalin or Duloxetine or Placebo |
| Duloxetine | Active comparator | Duloxetine 30mg ON week 1 increase to Duloxetine 60mg weeks 2-11 then decrease to Duloxetine 30mg ON week 12 then STOP Receives: Drug: Pregabalin or Duloxetine or Placebo |
| Placebo | Placebo comparator | 1 capsule ON week 1- increase to 2 capsules ON week 2-11 then decrease to 1 capsule ON week 12 then STOP. Receives: Drug: Pregabalin or Duloxetine or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Australian/Canadian Hand Osteoarthritis Index score (AUSCAN)
The AUSCAN measures pain and hand function. Differences between baseline AUSCAN and after treatment will be recorded for each participant to assess for improvement in AUSCAN pain and function score after the trial intervention.
Measured: 12 weeks
Secondary outcomes (1)
Brain magnetic resonance imaging (MRI)
Changes between baseline MRI and post-treatment after 12 weeks of intervention will be measured using functional neuroimaging to assess pain center activation before and after intervention.
Measured: Baseline and 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study startSep 2013
- Primary completionMay 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand OsteoarthritisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Rosetrees Trust
- Responsible party
- Sponsor
- Investigators
- Nidhi Sofat, MBBS, PhD, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612233
- Sponsor's protocol ID
- 11.0126
- Other IDs
- 2011-003803-39
- Acronym
- DUPRO
- Status last verified
- Jul 2016
- First submitted
- 18 Nov 2015
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management in Osteoarthritis Using the Centrally Acting Analgesics Duloxetine and Pregabalin
- ClinicalTrials.gov ID
- NCT02612233
- Acronym / sponsor ID
- DUPRO / 11.0126
- Conditions
- Hand Osteoarthritis
- Keywords
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- Rosetrees Trust
- Study start
- Sep 2013
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 23 Nov 2015 (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.
Osteoarthritis is the most common form of arthritis worldwide. Specifically, osteoarthritis of the hands affects millions of people and is a major cause of hand disability and pain. Despite this, there are currently no treatments that delay or halt the development of osteoarthritis. Pain is one of the major symptoms of osteoarthritis and pain management is an important factor to consider in the treatment of this condition. Treatments for pain in osteoarthritis consists of local injections, anti-inflammatory gels or painkillers such as paracetamol. However, most people with osteoarthritis still have pain despite these treatments.
Detailed description
Recent scientific studies have suggested that people with hand osteoarthritis not only feel pain in their hand joints, they also appear to have increased signals in their brain pain processing pathways. At St George's, University of London, the investigators have been conducting studies to find out which brain regions are activated in subjects with hand osteoarthritis. The investigators have found that certain brain regions (thalamus, insula, cingulate and somatosensory cortex) are activated during painful tasks in patients with hand osteoarthritis but not in healthy people. In this study the investigators will establish whether drugs that inhibit pain processing pathways in the brain can help. Patients who are still having pain despite their usual painkillers will be randomly divided into 3 groups: one group will receive a placebo, the other 2 groups will receive one of two different drugs, duloxetine or pregabalin. Participants will be assessed using questionnaires and a brain scan (functional MRI) before and after 13 weeks of taking the tablets. This study will help us to understand the ways in which people feel pain in osteoarthritis. If our trial proves successful,drugs that dampen central pain pathways could be used in combination with local pain-relieving drugs to improve treatment and reduce disability in patients with hand osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Active comparator | Drug: Pregabalin or Duloxetine or PlaceboPregabalin 150mg ON week 1 increased to Pregabalin 300mg ON weeks 2-11 then decrease to Pregabalin 150mg ON week 12 then STOP |
| Duloxetine | Active comparator | Drug: Pregabalin or Duloxetine or PlaceboDuloxetine 30mg ON week 1 increase to Duloxetine 60mg weeks 2-11 then decrease to Duloxetine 30mg ON week 12 then STOP |
| Placebo | Placebo comparator | Drug: Pregabalin or Duloxetine or Placebo1 capsule ON week 1- increase to 2 capsules ON week 2-11 then decrease to 1 capsule ON week 12 then STOP. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of hand osteoarthritis
- Participants with hand osteoarthritis presenting to rheumatology outpatient clinics and primary care.
- Participants will be right or left handed
- Male or female
- Age between 40 and 75
Key exclusion criteria (6 listed)
- Participants with other rheumatological diagnoses e.g. rheumatoid arthritis
- Current or planned pregnancy
- Contraindications to duloxetine or pregabalin
- History of depression
- Recent surgery
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 |
|---|---|---|
| Pregabalin or Duloxetine or PlaceboAlso: DUPRO CapsulesThis is a randomized, double blind placebo controlled trial with a head-to-head comparison of duloxetine vs pregabalin vs placebo over-encapsulated to prevent unblinding of treatment arm | Drug | Duloxetine, Placebo, Pregabalin |
Primary outcome
Australian/Canadian Hand Osteoarthritis Index score (AUSCAN)
Time frame: 12 weeks
The AUSCAN measures pain and hand function. Differences between baseline AUSCAN and after treatment will be recorded for each participant to assess for improvement in AUSCAN pain and function score after the trial intervention.
1 secondary outcome
Brain magnetic resonance imaging (MRI)
Time frame: Baseline and 12 weeks after treatment
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 20 Jul 2016.
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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.
Nidhi Sofat, MBBS, PhD principal investigator
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Hand Osteoarthritis, run by St George's, University of London 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 6 inclusion and 6 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 20 Jul 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Australian/Canadian Hand Osteoarthritis Index score (AUSCAN) (time frame: 12 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 20 Jul 2016.