PainPhase 2NCT02712957
A Proof-of-Concept Study Assessing NEO6860 in Osteoarthritis Pain
A Phase 2 study testing NEO6860 and Naproxen in people with Pain and Osteoarthritis of the Knee, run by Neomed Institute at 3 sites in Canada.
Trial summary
The purpose of this study is to assess NEO6860, a modality selective TRPV1 antagonist, in patients with pain associated with osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pain, Osteoarthritis of the Knee
- What is being tested?
- NEO6860 and Naproxen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 3 sitesCanada
- Study dates
- Mar 2016to 24 Nov 2016
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive;
- Patients diagnosed with osteoarthritis of the knee, according to American College of Rheumatology (ACR) guidelines, by meeting at least 3 of the following: age > 50, morning stiffness < 30 minutes, crepitus on active motion, bone tenderness, bone enlargement, no palpable warmth of synovium;
- Grade I, II or III using Kellgren-Lawrence classification on an X-Ray of the knee
- WOMAC pain subscale ≥ 8
- R square of the Focused Analgesia Selection Task (FAST) outcome value greater than 0.70
Who cannot join
- Patients with, or with a history of, any clinically significant disorders (including fibromyalgia and other painful disorders) which may interfere with the primary objectives of the study
- Patients treated in the previous 3 months with topical capsaicin or intra-articular corticosteroids;
- Patients with a contra-indication for the use of Naproxen or acetaminophen;
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Diex Recherche Montreal Inc
Montreal, Quebec, H2Y 1S1
Algorithme Pharma
Montreal, Quebec, H3P 3P1
Diex Recherche Sherbrooke Inc
Sherbrooke, Quebec, J1H 1Z1
About this study
Official title: A Proof-of-Concept, Randomized, Double Blind, Placebo and Active Control, 3-Period, Crossover Design Study Assessing NEO6860 in Patients With Pain Associated With Osteoarthritis of the Knee
The purpose of this study is to assess NEO6860, a modality selective TRPV1 antagonist, in patients with pain associated with osteoarthritis of the knee.
Read the detailed description
The study will be randomized, double blind, placebo and active control, a 3-way, 3-period crossover design, where each of the estimated 50 enrolled patients will receive alternately (i) NEO6860 (500 mg bid), (ii) placebo and (iii) Naproxen (500 mg bid). To ensure blinding, double dummy techniques will be used, so that at each period, patient will receive an oral liquid suspension (NEO6860 or its placebo) and one capsule (naproxen or its placebo).
Following a screening period, a maximum of 28 days before dosing, subjects will be randomized to one of the scheduled sequences. At each dosing period, subjects will be requested to participate in 2 clinic visits:
- One residential visit, the morning of investigational product dosing. Subjects will stay in the Clinical Research Unit approximately 13 hours
- One end of period visit, 24 h after first dosing A total of 2 washout periods of 1 to 3 weeks will separate the dosing periods. Once the 3 dosing periods will be completed, the subjects will come back to the clinic for a follow up visit (7 to 10 days post last dose).
Note: for a subpopulation, at one site, an assessment of heat pain threshold and tolerance will be conducted requiring a residential period of approximately 24 hours.
- Conditions
- Pain, Osteoarthritis of the Knee
- Being tested
- NEO6860, NEO6860 placebo, Naproxen, Naproxen placebo
- Medical subject headings
- Pain, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEO6860Drug
TRPV1 antagonist
NEO6860 placeboDrug
Inactive substance
NaproxenDrug
NSAID
Naproxen placeboDrug
inactive substance
| Study group | Role | What they receive |
|---|---|---|
| NEO6860 | Experimental | NEO6860 is provided as a powder in individual containers to be reconstituted as a suspension. In this arm patients will receive both NEO6860 and a placebo of naproxen. Receives: Drug: NEO6860; Drug: Naproxen placebo |
| Placebo | Placebo comparator | In this arm, patients will receive both placebo: oral liquid suspension (NEO6860 placebo) and capsule (naproxen placebo). Receives: Drug: NEO6860 placebo; Drug: Naproxen placebo |
| Naproxen | Active comparator | Naproxen is provided as over-encapsulated tablets using a commercially approved medication. In this arm patients will receive both naproxen and a placebo of NEO6860. Receives: Drug: NEO6860 placebo; Drug: Naproxen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Numerical Rating Scale (NRS, 0-10) from baseline after the staircase test to 8 hours post first dose after the staircase test on the index knee.
Patients are asked to step fully up onto a 8-inch (20 cm) high platform with both feet and back down a total of 24 times.
Measured: 8 hours post dosing. This endpoint will be collected 3 times, 8 hours post dosing for each period: NEO6860, naproxen and placebo.
Secondary outcomes (2)
WOMAC 3.1 Index Likert pain subscale
Measured: from baseline (screening) to 24 hour recall post 1 day treatment at each of the 3 periods
Patient's Global Impression of Change (PGIC)
Measured: 24 hour post 1 day treatment at each of the 3 periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion17 Nov 2016
- Study completion24 Nov 2016
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neomed Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan A Chiche, MD, Study director, Neomed Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712957
- Sponsor's protocol ID
- NEO6860-OA-01
- Status last verified
- Mar 2017
- First submitted
- 9 Mar 2016
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-Concept, Randomized, Double Blind, Placebo and Active Control, 3-Period, Crossover Design Study Assessing NEO6860 in Patients With Pain Associated With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02712957
- Acronym / sponsor ID
- NEO6860-OA-01
- Conditions
- Pain, Osteoarthritis of the Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Neomed InstituteUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 17 Nov 2016 (actual)
- Study completion
- 24 Nov 2016 (actual)
- First posted
- 18 Mar 2016 (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 this study is to assess NEO6860, a modality selective TRPV1 antagonist, in patients with pain associated with osteoarthritis of the knee.
Detailed description
The study will be randomized, double blind, placebo and active control, a 3-way, 3-period crossover design, where each of the estimated 50 enrolled patients will receive alternately (i) NEO6860 (500 mg bid), (ii) placebo and (iii) Naproxen (500 mg bid). To ensure blinding, double dummy techniques will be used, so that at each period, patient will receive an oral liquid suspension (NEO6860 or its placebo) and one capsule (naproxen or its placebo).
Following a screening period, a maximum of 28 days before dosing, subjects will be randomized to one of the scheduled sequences. At each dosing period, subjects will be requested to participate in 2 clinic visits:
- One residential visit, the morning of investigational product dosing. Subjects will stay in the Clinical Research Unit approximately 13 hours
- One end of period visit, 24 h after first dosing A total of 2 washout periods of 1 to 3 weeks will separate the dosing periods. Once the 3 dosing periods will be completed, the subjects will come back to the clinic for a follow up visit (7 to 10 days post last dose).
Note: for a subpopulation, at one site, an assessment of heat pain threshold and tolerance will be conducted requiring a residential period of approximately 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NEO6860 | Experimental | Drug: NEO6860, Drug: Naproxen placeboNEO6860 is provided as a powder in individual containers to be reconstituted as a suspension. In this arm patients will receive both NEO6860 and a placebo of naproxen. |
| Placebo | Placebo comparator | Drug: NEO6860 placebo, Drug: Naproxen placeboIn this arm, patients will receive both placebo: oral liquid suspension (NEO6860 placebo) and capsule (naproxen placebo). |
| Naproxen | Active comparator | Drug: NEO6860 placebo, Drug: NaproxenNaproxen is provided as over-encapsulated tablets using a commercially approved medication. In this arm patients will receive both naproxen and a placebo of NEO6860. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive;
- Patients diagnosed with osteoarthritis of the knee, according to American College of Rheumatology (ACR) guidelines, by meeting at least 3 of the following: age > 50, morning stiffness < 30 minutes, crepitus on active motion, bone tenderness, bone enlargement, no palpable warmth of synovium;
- Grade I, II or III using Kellgren-Lawrence classification on an X-Ray of the knee
- WOMAC pain subscale ≥ 8
- R square of the Focused Analgesia Selection Task (FAST) outcome value greater than 0.70
Key exclusion criteria (3 listed)
- Patients with, or with a history of, any clinically significant disorders (including fibromyalgia and other painful disorders) which may interfere with the primary objectives of the study
- Patients treated in the previous 3 months with topical capsaicin or intra-articular corticosteroids;
- Patients with a contra-indication for the use of Naproxen or acetaminophen;
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 |
|---|---|---|
| NEO6860TRPV1 antagonist | Drug | NEO6860 |
| NEO6860 placeboInactive substance | Drug | Naproxen, Placebo |
| NaproxenNSAID | Drug | Naproxen |
| Naproxen placeboinactive substance | Drug | NEO6860, Placebo |
Primary outcome
Mean change in Numerical Rating Scale (NRS, 0-10) from baseline after the staircase test to 8 hours post first dose after the staircase test on the index knee.
Time frame: 8 hours post dosing. This endpoint will be collected 3 times, 8 hours post dosing for each period: NEO6860, naproxen and placebo.
Patients are asked to step fully up onto a 8-inch (20 cm) high platform with both feet and back down a total of 24 times.
2 secondary outcomes
WOMAC 3.1 Index Likert pain subscale
Time frame: from baseline (screening) to 24 hour recall post 1 day treatment at each of the 3 periods
Patient's Global Impression of Change (PGIC)
Time frame: 24 hour post 1 day treatment at each of the 3 periods
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 13 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Dan A Chiche, MD study director
Neomed Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NEO6860 and Naproxen in people with Pain and Osteoarthritis of the Knee, run by Neomed Institute at 3 sites in Canada.
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 5 inclusion and 3 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 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Mean change in Numerical Rating Scale (NRS, 0-10) from baseline after the staircase test to 8 hours post first dose after the staircase test on the index knee. (time frame: 8 hours post dosing. This endpoint will be collected 3 times, 8 hours post dosing for each period: NEO6860, naproxen and placebo.). 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 13 Mar 2017.