OsteoarthritisPhase 2NCT03978208
Efficacy and Safety of ATB-346 Versus Placebo in Osteoarthritis Patients
A Phase 2 study testing ATB-346 low dose, ATB-346 mid-dose and ATB-346 standard dose in people with Osteoarthritis, run by Antibe Therapeutics Inc. at 35 sites in Canada.
Trial summary
The primary objective of this study is to evaluate the efficacy of a 14-day dosing regimen of ATB-346 at doses of 150 mg, 200 mg and 250 mg compared to placebo in reducing osteoarthritis knee pain as measured by changes in the post-treatment WOMAC subscale pain score relative to each patient's pretreatment baseline… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- ATB-346 low dose, ATB-346 mid-dose and ATB-346 standard dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 381 participants
- Where
- 35 sitesCanada
- Study dates
- 29 Mar 2019to 29 Dec 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis greater than 2 years duration requiring the use of regular therapies, e.g. oral or topical anti-inflammatories, acetaminophen, topical capsaicin
- Between the ages of 40 to 75
- BMI ≤40
- Patients must be unlikely to procreate or agree to the use of acceptable contraceptive regimens from first drug administration , during the study, and for at least 30 days after the last dose
- Patients must not have used aspirin or naproxen-containing medications for 7 days prior to study entry
- Patients must not have used any anti-inflammatory medications or acetaminophen for 5 days prior to study entry
- Patients must show a ≥10-point increase in WOMAC Visual Analog Score between their screening visit and baseline study entry visit
Who cannot join
- Females who are pregnant or breastfeeding
- Seated and resting pulse rate less than 50 beats per minute (bpm) or more than 100 bpm at screening
- Seated and resting blood pressure below 100/60 mmHg or higher than 140/90 mmHg at screening
- History of significant hypersensitivity to naproxen, other non-steroidal anti-inflammatory agents, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Patients with a history of GI bleeding or ulceration
- Patients refractory to NSAIDs
Show all 19Show fewer
- Presence of significant gastrointestinal, liver, or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or know to potentiate or predispose patients to undesired effects
- Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease as determined by the investigator
- Suicidal tendency, history of/or disposition to seizures, state of confusion
- History of hepatic disease
- Maintenance therapy with any drug, including gastroprotective agents such as proton pump inhibitors, H2 receptor antagonists, sucralfate, etc., or significant history of drug dependency or alcohol abuse (>3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
- Any clinically significant illness in the previous 30 days before Day 1 of this study
- Use of any enzyme-modifying drugs, including strong inhibitors of CYP enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem, and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort) in the previous 30 days before Day 1 of this study
- Any history of tuberculosis and/or prophylaxis for tuberculosis
- Positive H. Pylori Urea Breathe Test
- Positive urine screening of alcohol and/or drugs of abuse at the screening visit
- Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAg) or anti-Hepatitis C Virus (HCV) tests
- Females who are pregnant according to a positive serum pregnancy test
- Patients who took an Investigational Product (in another clinical trial) in the previous 30 days before Day 1 of this study.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
Canada35 sites
Aggarwal and Associates Limited
Brampton, Ontario, L6T 0G1
Manna Research (Burlington North)
Burlington, Ontario, L7M 4Y1
Etobicoke Medical Centre
Etobicoke, Ontario, M8Z 5W4
Dawson Clinical Research
Guelph, Ontario, N1H 1B1
True North Clinical Research Inc.
Halifax, Nova Scotia, B3S 1M7
Dr. Allen Greenspoon Medicine Professional Corporation
Hamilton, Ontario, L8L 5G8
Hamilton Medical Research Group
Hamilton, Ontario, L8M 1K7
Manna Research (Quebec)
Lévis, Quebec, G6W 0M5
Milestone Research Inc.
London, Ontario, N5W 6A2
KGK Science Inc
London, Ontario, N6A 5R8
Manna Research (Mirabel QC)
Mirabel, Quebec, J7J 2K8
Viable Clinical Research Corp
Mission, British Columbia, V2V 1C6
Malton Medical Clinic
Mississauga, Ontario, L4V 1P1
Recherche GCP Research
Montreal, Quebec, H1M 1B1
Centre Medical Acadie
Montreal, Quebec, H4N 2W2
SKDS Research Inc
Newmarket, Ontario, L3Y 5G8
King Street Medical Clinic
Oshawa, Ontario, L1H 1G6
Manna Research (Montreal)
Pointe-Claire, Quebec, H9R 4S3
Diex Recherche Quebec Inc.
Québec, Quebec, G1N 4V3
Centre de Recherche Saint-Louis
Québec, Quebec, G1W 4R4
Bluewater Clinical Research Group Inc
Sarnia, Ontario, N7T 4X3
Viable Clinical Research Corp
Scarborough Village, Ontario, M1P 2T7
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, J1L 0H8
Dr. Steven V. Zizzo Medicine Professional Corporation
Stoney Creek, Ontario, L8J 0B6
Manna Research (Stoney Creek)
Stoney Creek, Ontario, L8J 3W2
Ocean West Research Clinic
Surrey, British Columbia, V3Z 2N6
Canadian Phase Onward Inc.
Toronto, Ontario, M3J 0K2
LMC Clinical Research Inc
Toronto, Ontario, M4G 3E8
Manna Research (Toronto)
Toronto, Ontario, M9W 4L6
James K. Lai MD Inc
Vancouver, British Columbia, V5Z 1K3
Dr. MB Jones Inc
Victoria, British Columbia, V8V 4A1
Diex Recherche Victoriaville Inc.
Victoriaville, Quebec, G6P 6P6
Dr. Sabeen Anwar Medicine Professional Corporation
Windsor, Ontario, N8X 1T3
Clinical Research& Arthritis Centre
Windsor, Ontario, N8X 2C9
Devonshire Clinical Research Inc.
Woodstock, Ontario, N4S 5P5
About this study
Official title: A Double-Blind, Placebo-Controlled, Phase 2B Study to Assess the Efficacy and Safety of a 14-Day Dosing Regimen of 3 Doses of ATB-346 Versus Placebo, Orally Administered Once Daily to Patients Diagnosed With Osteoarthritis of the Knee
The primary objective of this study is to evaluate the efficacy of a 14-day dosing regimen of ATB-346 at doses of 150 mg, 200 mg and 250 mg compared to placebo in reducing osteoarthritis knee pain as measured by changes in the post-treatment WOMAC subscale pain score relative to each patient's pretreatment baseline WOMAC assessment.Safety will be assessed via measurements of vital signs and clinical laboratory tests at baseline and at various time points during the study, patient monitoring, and by the documentation of adverse events.
Read the detailed description
The primary objective of this study is to evaluate the efficacy of a 14-day dosing regimen of once daily administration of ATB-346 at doses of 150 mg, 200 mg and 250 mg compared to placebo in reducing osteoarthritis knee pain as measured by changes in the post-treatment WOMAC subscale pain score relative to each patient's pretreatment baseline WOMAC assessment.A total of 360 evaluable patients are planned in this study: 250 mg (n=120); 200 mg (n=120); 150 mg (n=60); placebo (n=60).
Safety will be assessed via measurements of vital signs and clinical laboratory tests at baseline and at various time points during the study, patient monitoring, and by the documentation of adverse events.
- Conditions
- Osteoarthritis
- Being tested
- ATB-346 low dose, Placebo, ATB-346 mid-dose, ATB-346 standard dose
- Keywords
- Knee, WOMAC, NSAID, Pain
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATB-346 low doseDrug
Also called Active comparator
Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients
PlaceboOther
Also called Non-active comparator
Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients
ATB-346 mid-doseDrug
Also called Active comparator
Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients
ATB-346 standard doseDrug
Also called Active comparator
Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator | Active comparator | ATB-346 150 mg overencapsulated tablet taken by mouth once daily for 14 days Receives: Drug: ATB-346 low dose |
| ATB-346 mid-dose | Active comparator | ATB-346 200 mg overencapsulated tablet taken by mouth once daily for 14 days Receives: Drug: ATB-346 mid-dose |
| ATB-346 standard dose | Active comparator | ATB-346 250 mg overencapsulated tablet taken by mouth once daily for 14 days Receives: Drug: ATB-346 standard dose |
| Active Comparator | Placebo comparator | Overencapsulated placebo tablet taken by mouth once daily for 14 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-item pain intensity measure
Self reported pain intensity over the past 48 hours. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total between 0 and 50
Measured: Previous 48 hours
Secondary outcomes (5)
2-item stiffness intensity measure
Self reported pain intensity over the past 48 hours. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total between 0 and 20
Measured: Previous 48 hours
17-item difficulty performing daily activities measure
Self reported pain intensity over the past 48 hours. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total between 0 and 170
Measured: Previous 48 hours
Measurement of whole blood cyclo-oxygenase activity
Thromboxane B2 (TXB2) blood levels (pg/mL) will be measured after 1, 4 and 14 days of treatment. samples taken on days 1, 4 and 14. Decreases (measured in pg/mL) in the blood levels of thromboxane B2 are a direct measure of the effect of treatment on cyclo-oxygenase activity and the reduced production of this inflammatory mediator, i.e., thromboxane B2.
Measured: After 1, 4 and 14 days of treatment dosing.
Number of patients with genetic variations in the drug modifying enzyme CYP2C9 that may alter the metabolism of ATB-346 will be investigated.
CYP2C9 isoforms will be measured in one blood sample taken prior to study drug dosing.
Measured: Samples will be retained through study completion and analyzed within 1 year of study initiation.
Number of participants with treatment-related adverse events
The safety of ATB-346 will be monitored via on study and two week post study physician and clinical laboratory assessments.
Measured: Pre-study and days 4, 14 and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start29 Mar 2019
- Primary completion29 Dec 2019
- Study completion29 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antibe Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Veristat, Inc.
- Responsible party
- Sponsor
- Investigators
- Deepen Patel, MD, Study director, Veristat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978208
- Sponsor's protocol ID
- ATB-346-P2B-DRF
- Status last verified
- Jul 2022
- First submitted
- 18 Mar 2019
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Phase 2B Study to Assess the Efficacy and Safety of a 14-Day Dosing Regimen of 3 Doses of ATB-346 Versus Placebo, Orally Administered Once Daily to Patients Diagnosed With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT03978208
- Acronym / sponsor ID
- ATB-346-P2B-DRF
- Conditions
- Osteoarthritis
- Keywords
- Knee, WOMAC, NSAID, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Antibe Therapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Veristat, Inc.
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 29 Dec 2019 (actual)
- Study completion
- 29 Dec 2019 (actual)
- First posted
- 7 Jun 2019 (actual)
- 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 primary objective of this study is to evaluate the efficacy of a 14-day dosing regimen of ATB-346 at doses of 150 mg, 200 mg and 250 mg compared to placebo in reducing osteoarthritis knee pain as measured by changes in the post-treatment WOMAC subscale pain score relative to each patient's pretreatment baseline WOMAC assessment.Safety will be assessed via measurements of vital signs and clinical laboratory tests at baseline and at various time points during the study, patient monitoring, and by the documentation of adverse events.
Detailed description
The primary objective of this study is to evaluate the efficacy of a 14-day dosing regimen of once daily administration of ATB-346 at doses of 150 mg, 200 mg and 250 mg compared to placebo in reducing osteoarthritis knee pain as measured by changes in the post-treatment WOMAC subscale pain score relative to each patient's pretreatment baseline WOMAC assessment.A total of 360 evaluable patients are planned in this study: 250 mg (n=120); 200 mg (n=120); 150 mg (n=60); placebo (n=60).
Safety will be assessed via measurements of vital signs and clinical laboratory tests at baseline and at various time points during the study, patient monitoring, and by the documentation of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator | Active comparator | Drug: ATB-346 low doseATB-346 150 mg overencapsulated tablet taken by mouth once daily for 14 days |
| ATB-346 mid-dose | Active comparator | Drug: ATB-346 mid-doseATB-346 200 mg overencapsulated tablet taken by mouth once daily for 14 days |
| ATB-346 standard dose | Active comparator | Drug: ATB-346 standard doseATB-346 250 mg overencapsulated tablet taken by mouth once daily for 14 days |
| Active Comparator | Placebo comparator | Other: PlaceboOverencapsulated placebo tablet taken by mouth once daily for 14 days |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis greater than 2 years duration requiring the use of regular therapies, e.g. oral or topical anti-inflammatories, acetaminophen, topical capsaicin
- Between the ages of 40 to 75
- BMI ≤40
- Patients must be unlikely to procreate or agree to the use of acceptable contraceptive regimens from first drug administration , during the study, and for at least 30 days after the last dose
- Patients must not have used aspirin or naproxen-containing medications for 7 days prior to study entry
Key exclusion criteria (19 listed)
- Females who are pregnant or breastfeeding
- Seated and resting pulse rate less than 50 beats per minute (bpm) or more than 100 bpm at screening
- Seated and resting blood pressure below 100/60 mmHg or higher than 140/90 mmHg at screening
- History of significant hypersensitivity to naproxen, other non-steroidal anti-inflammatory agents, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Patients with a history of GI bleeding or ulceration
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 |
|---|---|---|
| ATB-346 low doseAlso: Active comparatorDouble blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients | Drug | Placebo Comparator |
| PlaceboAlso: Non-active comparatorDouble blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients | Other | Active Comparator |
| ATB-346 mid-doseAlso: Active comparatorDouble blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients | Drug | ATB-346 mid-dose |
| ATB-346 standard doseAlso: Active comparatorDouble blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients | Drug | ATB-346 standard dose |
Primary outcome
5-item pain intensity measure
Time frame: Previous 48 hours
Self reported pain intensity over the past 48 hours. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total between 0 and 50
5 secondary outcomes
2-item stiffness intensity measure
Time frame: Previous 48 hours
17-item difficulty performing daily activities measure
Time frame: Previous 48 hours
Measurement of whole blood cyclo-oxygenase activity
Time frame: After 1, 4 and 14 days of treatment dosing.
Number of patients with genetic variations in the drug modifying enzyme CYP2C9 that may alter the metabolism of ATB-346 will be investigated.
Time frame: Samples will be retained through study completion and analyzed within 1 year of study initiation.
Number of participants with treatment-related adverse events
Time frame: Pre-study and days 4, 14 and 24.
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 21 Jul 2022.
- Individual participant dataSharing planned: No
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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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.
Deepen Patel, MD study director
Veristat
35 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 ATB-346 low dose, ATB-346 mid-dose and ATB-346 standard dose in people with Osteoarthritis, run by Antibe Therapeutics Inc. at 35 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 7 inclusion and 19 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 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 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?
5-item pain intensity measure (time frame: Previous 48 hours). 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 21 Jul 2022.