Osteoarthritis of the KneePhase 2NCT01768975
Phase 2 Efficacy Trial of OLT1177 Gel in Subjects With Moderate to Severe Pain Associated With OA of the Knee
A Phase 2 study testing OLT1177 Gel in people with Osteoarthritis of the Knee, run by Olatec Therapeutics, Inc. at 3 sites in United States.
Trial summary
The purpose of this trial is to investigate the efficacy and safety of OLT1177 Gel in subjects with moderate to severe pain associated with osteoarthritis of the knee following cessation of pain therapy. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- OLT1177 Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2013to Aug 2013
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 35 to 80
- Subjects of childbearing potential and their partners must use effective contraception
- OA based on the ACR criteria
- OA of the knee ≥ 6 months prior to Screening
- OA knee pain which required NSAID or other therapy for ≥ 15 days
- Pain on Movement in the contralateral knee be ≤ 20 mm
Show all 11Show fewer
- Radiographic evidence of OA by Kellgren-Lawrence score of 2 or 3 taken 6 months prior to Screening
- Moderate to severe OA pain defined as POM score between 50 mm and 90 mm
- Baseline WOMAC pain subscale score ≥ 9
- No change in physical activity and/or therapy for the past 3 months
- Provide written informed consent and comply with the trial
Who cannot join
- Use of Rescue Medication or any other pain medication 48 hours prior to Baseline visit
- Inflammatory skin condition over the target knee
- Extreme pain in the target knee characterized by POM score of > 90 mm
- Mild pain in the target knee, characterized by POM score of < 50 mm
- > 30 mm POM score variability in Days -2 to -1 from Baseline visit
- Baseline POM score of > 20 mm for the contralateral knee or any other significant joint or general pain at Baseline visit
Show all 47Show fewer
- Excessive effusion in the target knee
- Heat and/or redness in comparison to the contralateral knee
- Knock-kneed or bow-legged defined by valgus or varus deformity of ≥ 15 degrees
- Acute or chronic injury other than OA
- Radiographic evidence of OA by Kellgren-Lawrence score of 0, 1 or 4
- Open surgery of the target knee within the last year
- Arthroscopic surgery of the target knee within the last 6 months
- Surgery of the target knee requiring insertion of a medical device or surgical hardware
- Use of prohibited concomitant medications/therapies during the 7-day washout period or planned use during the 14-day treatment period including:
- Prescription medications to treat pain, OTC and natural supplements
- Muscle relaxants unless on a stable dose ≥ 30 days prior to Screening
- Nutraceuticals unless on a stable dose ≥ 3 months prior to Screening
- Sedative hypnotics unless on a stable dose ≥ 30 days prior to Screening
- Devices or therapeutic treatments for knee pain or ambulation
- Systemic corticosteroids
- Other Investigational Drugs
- Chemotherapeutic drugs
- Immunotherapy
- Topical products applied to the target knee
- Cyclosporine (except ophthalmic), lithium, methotrexate
- Anti-depressants or medications acting on the central nervous system, unless on a stable dose for depression ≥ 3 months prior to Screening
- Narcotics or previous history of chronic narcotic use
- Rescue Medication within 48 hours of Baseline, Day 7 or Day 14 visits
- Intraarticular steroids in the target knee within the previous 3 months or in any other joint within the previous 30 days
- Intraarticular hyaluronate within the previous 6 months or in any other joint within the previous 30 days
- Systemic corticosteroids within the prior month
- Documented history of inflammatory joint disease
- BMI over 35
- Uncontrolled psychiatric conditions
- Cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological or neurological disease or prior surgery
- Uncontrolled hypertension
- Diabetes with an HbA1c level > 8
- Known positive for HIV, Hepatitis B surface antigen (HBsAg) or antibodies to Hepatitis C Virus (HCV)
- Cancer within the past 5 years, except for treated basal cell or squamous cell carcinoma of the skin
- Any other medical conditions, diseases or prior surgeries
- Interventional and/or surgical procedure during the 28 days following randomization
- Change in level of physical activity during the 28 days following randomization
- Active infection or fever ≥ 38°C within 3 days of Baseline visit
- Known sensitivity to Investigational Drug
- Women planning to become pregnant during the 28-day trial
- Participation in any Investigational Drug or device trial within 30-day prior to Baseline visit
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Avail Clinical Research
DeLand, Florida, 32720
Wake Research Associates
Raleigh, North Carolina, 27612
Miami Research Associates
South Miami, Florida, 33143
About this study
Official title: Randomized, Double-Blind, Vehicle-Controlled, Efficacy and Safety Clinical Trial of Topically Applied OLT1177 Gel in Subjects With Moderate to Severe Pain Associated With Osteoarthritis of the Knee Following Cessation of Pain Therapy
The purpose of this trial is to investigate the efficacy and safety of OLT1177 Gel in subjects with moderate to severe pain associated with osteoarthritis of the knee following cessation of pain therapy.
Read the detailed description
This is a randomized, double-blind, vehicle-controlled, repeat-dose, multi-center Phase 2 efficacy and safety clinical trial of subjects with moderate to severe pain associated with osteoarthritis of the knee. Eighty-four subjects, randomized in a 2:1 ratio (OLT1177 Gel to vehicle control) will receive up to 40 doses of the Investigational Drug (56 subjects OLT1177 Gel and 28 subjects vehicle control) over 14 consecutive days given 3 times per day (4 mL per dose, TID on Days 1 - 13 with only one dose administered on Day 14, assuming TID on Day 1) and will have safety data collected through Day 28. Subjects with moderate to severe pain associated with osteoarthritis of the knee will be evaluated twice for eligibility: 1) at the Screening visit; and 2) at the Baseline (Day 0) visit, after a 7-day washout period of all pain medications except for trial provided Rescue Medication (500 mg/dose of acetaminophen) for those that experience unacceptable pain during the washout and 14-day treatment period.
Subjects will be encouraged not to take any pain medication during the 7-day washout period; however, for the first 5 days they are allowed to take only Rescue Medication. No pain medication, including Rescue Medication, is allowed during the 2-day pain intensity assessment period or within 48 hours of the Baseline (Day 0), Day 7 and Day 14 visits.
Subjects will be asked to record and report their level of pain at different time points throughout the 14-day trial.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- OLT1177 Gel, Placebo gel
- Keywords
- Knee, Osteoarthritis, OA, Knee pain, Moderate pain, Severe pain, Inflammation, Safety, Efficacy, Randomized, Topical, Gel, Olatec, OLT1177, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Arthritis, Therapeutic, Analgesic
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain, Inflammation, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLT1177 GelDrug
Also called OLT1177
4 mL per dose, applied 3 times per day on Days 1 - 13 with only one dose administered on Day 14, assuming TID on Day 1
Placebo gelOther
Identical dose and dosing regimen as the Investigational Drug (OLT1177 Gel)
| Study group | Role | What they receive |
|---|---|---|
| OLT1177 Gel | Experimental | 4 mL per dose, applied 3 times per day on Days 1 - 13 with only one dose administered on Day 14, assuming TID on Day 1 Receives: Drug: OLT1177 Gel |
| Placebo gel | Placebo comparator | Identical dose and dosing regimen as the Investigational Drug (OLT1177 Gel) Receives: Other: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WOMAC knee pain subscale (scale 0 - 20)
The mean group change for OLT1177 Gel and vehicle control from Baseline (Day 0) to Day 14 in WOMAC knee pain subscale (Scale 0-20), which is determined by the subjects responses to five questions (S1-S5) using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4)
Measured: 14 days
Secondary outcomes (17)
Change in Current Knee Pain (100-mm VAS)
The mean group change in Current Knee Pain (100-mm VAS) for OLT1177 Gel and vehicle control from Baseline (Day 0) pre-dose to Day 1, 50-minutes post-dose (± 10 minutes) calculated in millimeters and percentage, as recorded by the subjects during the Baseline (Day 0) visit after the first application of the Investigational Drug
Measured: 50 minutes post dose (± 10 minutes)
Mean group rating of Relative Knee Pain (5-point scale)
The mean group rating of Relative Knee Pain (5-point scale) for OLT1177 Gel and vehicle control at Day 1, 50-minutes post-dose (± 10 minutes) as recorded by the subjects during the Baseline (Day 0) visit after the first application of the Investigational Drug
Measured: 50 minutes post dose (± 10 minutes)
Change in WOMAC knee pain subscale
The mean group change for OLT1177 Gel and vehicle control from Baseline (Day 0) to Day 7 in WOMAC knee pain subscale (Scale 0-20), which is determined by the subjects responses to five questions during the Day 7 site visit
Measured: 7 days
Change in Pain on Movement (100-mm VAS)
The mean group change in Pain on Movement (100-mm VAS) for OLT1177 Gel and vehicle control from Baseline (Day 0) to Day 7, calculated in millimeters and percentage, as recorded by the subjects while at home
Measured: 7 days
Change in Pain on Movement (100-mm VAS)
The mean group change in Pain on Movement (100-mm VAS) for OLT1177 Gel and vehicle control from Baseline (Day 0) to Day 14, calculated in millimeters and percentage, as recorded by the subjects while at home
Measured: 14 days
Change in Global Rating of Disease
The mean group change in Global Rating of Disease for OLT1177 Gel and vehicle control from Baseline (Day 0) to Day 14 measured on a 5-point Likert scale, with numerical values to be assigned as follows: 0 = poor, 1 = fair, 2 = good, 3 = very good and 4 = excellent, as recorded by the subjects at the Day 14 site visit
Measured: 14 days
Change in Global Evaluation of Treatment
The mean group rating of Global Evaluation of Treatment for OLT1177 Gel and vehicle control at Day 14 measured on a 5-point Likert scale, with numerical values to be assigned as follows: 0 = poor, 1 = fair, 2 = good, 3 = very good and 4 = excellent, as recorded by the subjects at the Day 14 site visit
Measured: 14 days
Change in WOMAC Stiffness subscale (Scale 0-8)
The mean group change for OLT1177 Gel and vehicle control from Baseline (Day 0) to Day 7 in the WOMAC Stiffness subscale (Scale 0-8) and in the WOMAC Physical function subscale (Scale 0-68), which is determined by subjects responses to questions at the Day 7 site visit
Measured: 7 days
Change in WOMAC Stiffness subscale (Scale 0-8)
The mean group change for OLT1177 Gel and vehicle control from Baseline (Day 0) to Day 14 in the WOMAC Stiffness subscale (Scale 0-8) and in the WOMAC Physical function subscale (Scale 0-68), which is determined by subjects responses to questions at the Day 14 site visit
Measured: 14 days
Change in the use of Rescue Medication
The mean group change for OLT1177 Gel and vehicle control in the proportion of subjects who required the use of Rescue Medication
Measured: 14 days
Change in the time to use of Rescue Medication
The mean group time to use of Rescue Medication for OLT1177 Gel and vehicle control after the first dose of Investigational Drug
Measured: 14 days
Proportion of subjects experiencing an improvement in WOMAC knee pain subscale
The proportion of subjects who experience an improvement in WOMAC knee pain subscale (Scale 0-20, transformed to a 0 to 100 scale) from Baseline (Day 0) to Day 14 equal to or greater than the minimum clinically important improvement (MCII) threshold of 15-mm
Measured: 14 days
Proportion of subjects experiencing an improvement in WOMAC knee pain subscale
The proportion of subjects who experience an improvement in WOMAC knee pain subscale (Scale 0-20, transformed to a 0 to 100 scale) from Baseline (Day 0) to Day 14 equal to or greater than the minimum clinically important improvement (MCII) threshold of 20%
Measured: 14 days
Proportion of subjects whose WOMAC knee pain subscale is less than the PASS
The proportion of subjects whose WOMAC knee pain subscale (Scale 0-20, transformed to a 0 to 100 scale) at Day 14 is less than the patient acceptable symptom state (PASS) of 40
Measured: 14 days
Proportion of subjects experiencing an improvement in Pain on Movement
The proportion of subjects who experience an improvement in Pain on Movement (100-mm VAS) from Baseline (Day 0) to Day 14 equal to or greater than the minimum clinically important improvement (MCII) threshold of 15-mm
Measured: 14 days
Proportion of subjects experiencing an improvement in Pain on Movement
The proportion of subjects who experience an improvement in Pain on Movement (100-mm VAS) from Baseline (Day 0) to Day 14 equal to or greater than the minimum clinically important improvement (MCII) threshold of 20%
Measured: 14 days
Proportion of subjects whose POM is less than the PASS
The proportion of subjects whose Pain on Movement (100-mm VAS) at Day 14 is less than the patient acceptable symptom state (PASS) of 40-mm
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies 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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olatec Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaime A. Pachon, MD, Principal investigator, Miami Research AssociatesBruce G. Rankin, D.O., C.P.I, Principal investigator, Avail Clinical ResearchTreva W. Tyson, MD, Principal investigator, Wake Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768975
- Sponsor's protocol ID
- OLT1177-02
- Status last verified
- Sep 2014
- First submitted
- 14 Jan 2013
- Last updated
- 6 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Vehicle-Controlled, Efficacy and Safety Clinical Trial of Topically Applied OLT1177 Gel in Subjects With Moderate to Severe Pain Associated With Osteoarthritis of the Knee Following Cessation of Pain Therapy
- ClinicalTrials.gov ID
- NCT01768975
- Acronym / sponsor ID
- OLT1177-02
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Knee, Osteoarthritis, OA, Knee pain, Moderate pain, Severe pain, Inflammation, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Olatec Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 16 Jan 2013 (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 trial is to investigate the efficacy and safety of OLT1177 Gel in subjects with moderate to severe pain associated with osteoarthritis of the knee following cessation of pain therapy.
Detailed description
This is a randomized, double-blind, vehicle-controlled, repeat-dose, multi-center Phase 2 efficacy and safety clinical trial of subjects with moderate to severe pain associated with osteoarthritis of the knee. Eighty-four subjects, randomized in a 2:1 ratio (OLT1177 Gel to vehicle control) will receive up to 40 doses of the Investigational Drug (56 subjects OLT1177 Gel and 28 subjects vehicle control) over 14 consecutive days given 3 times per day (4 mL per dose, TID on Days 1 - 13 with only one dose administered on Day 14, assuming TID on Day 1) and will have safety data collected through Day 28. Subjects with moderate to severe pain associated with osteoarthritis of the knee will be evaluated twice for eligibility: 1) at the Screening visit; and 2) at the Baseline (Day 0) visit, after a 7-day washout period of all pain medications except for trial provided Rescue Medication (500 mg/dose of acetaminophen) for those that experience unacceptable pain during the washout and 14-day treatment period.
Subjects will be encouraged not to take any pain medication during the 7-day washout period; however, for the first 5 days they are allowed to take only Rescue Medication. No pain medication, including Rescue Medication, is allowed during the 2-day pain intensity assessment period or within 48 hours of the Baseline (Day 0), Day 7 and Day 14 visits.
Subjects will be asked to record and report their level of pain at different time points throughout the 14-day trial.
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 |
|---|---|---|
| OLT1177 Gel | Experimental | Drug: OLT1177 Gel4 mL per dose, applied 3 times per day on Days 1 - 13 with only one dose administered on Day 14, assuming TID on Day 1 |
| Placebo gel | Placebo comparator | Other: Placebo gelIdentical dose and dosing regimen as the Investigational Drug (OLT1177 Gel) |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 35 to 80
- Subjects of childbearing potential and their partners must use effective contraception
- OA based on the ACR criteria
- OA of the knee ≥ 6 months prior to Screening
- OA knee pain which required NSAID or other therapy for ≥ 15 days
Key exclusion criteria (47 listed)
- Use of Rescue Medication or any other pain medication 48 hours prior to Baseline visit
- Inflammatory skin condition over the target knee
- Extreme pain in the target knee characterized by POM score of > 90 mm
- Mild pain in the target knee, characterized by POM score of < 50 mm
- > 30 mm POM score variability in Days -2 to -1 from Baseline visit
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 |
|---|---|---|
| OLT1177 GelAlso: OLT11774 mL per dose, applied 3 times per day on Days 1 - 13 with only one dose administered on Day 14, assuming TID on Day 1 | Drug | OLT1177 Gel |
| Placebo gelIdentical dose and dosing regimen as the Investigational Drug (OLT1177 Gel) | Other | Placebo gel |
Primary outcome
Change in WOMAC knee pain subscale (scale 0 - 20)
Time frame: 14 days
The mean group change for OLT1177 Gel and vehicle control from Baseline (Day 0) to Day 14 in WOMAC knee pain subscale (Scale 0-20), which is determined by the subjects responses to five questions (S1-S5) using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4)
17 secondary outcomes
Change in Current Knee Pain (100-mm VAS)
Time frame: 50 minutes post dose (± 10 minutes)
Mean group rating of Relative Knee Pain (5-point scale)
Time frame: 50 minutes post dose (± 10 minutes)
Change in WOMAC knee pain subscale
Time frame: 7 days
Change in Pain on Movement (100-mm VAS)
Time frame: 7 days
Change in Pain on Movement (100-mm VAS)
Time frame: 14 days
Change in Global Rating of Disease
Time frame: 14 days
Change in Global Evaluation of Treatment
Time frame: 14 days
Change in WOMAC Stiffness subscale (Scale 0-8)
Time frame: 7 days
Change in WOMAC Stiffness subscale (Scale 0-8)
Time frame: 14 days
Change in the use of Rescue Medication
Time frame: 14 days
Change in the time to use of Rescue Medication
Time frame: 14 days
Proportion of subjects experiencing an improvement in WOMAC knee pain subscale
Time frame: 14 days
Proportion of subjects experiencing an improvement in WOMAC knee pain subscale
Time frame: 14 days
Proportion of subjects whose WOMAC knee pain subscale is less than the PASS
Time frame: 14 days
Proportion of subjects experiencing an improvement in Pain on Movement
Time frame: 14 days
Proportion of subjects experiencing an improvement in Pain on Movement
Time frame: 14 days
Proportion of subjects whose POM is less than the PASS
Time frame: 14 days
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 6 Oct 2014.
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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.
Jaime A. Pachon, MD principal investigator
Miami Research Associates
Bruce G. Rankin, D.O., C.P.I principal investigator
Avail Clinical Research
Treva W. Tyson, MD principal investigator
Wake Research Associates
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 OLT1177 Gel in people with Osteoarthritis of the Knee, run by Olatec Therapeutics, Inc. at 3 sites in United States.
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 11 inclusion and 47 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 6 Oct 2014. 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 United States. 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?
Change in WOMAC knee pain subscale (scale 0 - 20) (time frame: 14 days). 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 6 Oct 2014.