OsteoarthritisPhase 2NCT02104050
Study of OLT1177 Gel to Treat Moderate to Severe OA Knee Pain
A Phase 2 study testing OLT1177 Gel in people with Osteoarthritis and Pain, run by Olatec Therapeutics, Inc. at 13 sites in United States.
Trial summary
The objectives of this trial are to investigate the efficacy and safety of six weeks of treatment with 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 45 to 80 years
- Conditions the study is for
- Osteoarthritis, Pain
- What is being tested?
- OLT1177 Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 13 sitesUnited States
- Study dates
- Apr 2014to Aug 2015
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45 to 80 years old, inclusive
- Clinical diagnosis of osteoarthritis in one target knee based on the following American College of Rheumatology (ACR) criteria:
- Knee Pain
- At least 1 of 3:
- Age > 50 years
- Morning stiffness lasting < 30 minutes
Show all 14Show fewer
- Crepitus on motion
- Osteophytes on radiograph
- Symptoms associated with osteoarthritis of the knee (including pain) for ≥ 6 months prior to Screening
- Knee pain associated with osteoarthritis, which required NSAID or other therapy for ≥ 15 days during the preceding month
- Radiographic evidence of osteoarthritis by Kellgren-Lawrence classification with a rating of Grade 2 or 3 in the target knee (does not include borderline Grade 2), as confirmed by the Sponsor's designated rheumatologist through radiographic review of x-ray(s) taken no more than 1 year prior to the Screening visit. (Sharpening of the tibial spine is not considered to be an osteophyte) (See Appendix 4 for additional details)
- Meets pain assessment entry criteria as defined by Sponsor's pain eligibility algorithm and calculated by the study Interactive Web Response System
- No clinically significant change in physical activity and/or therapy for the past 3 months
- Able to provide written informed consent prior to initiation of any clinical trial-related procedures; and willing and able, in the opinion of the Investigator, to comply with all requirements of the clinical trial for the duration of the trial (such requirements include, but are not limited to: attending all study visits, refraining from elective surgery or extensive travel during participation)
Who cannot join
- General
- Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential may not be entered into the study if:
- They are or intend to become pregnant (including use of fertility drugs) during the study
- They are nursing
- They are not using an acceptable, highly effective method of contraception until all follow-up procedures are complete. (Acceptable, highly effective forms of contraception are defined as: oral contraception, intrauterine device, systemic [injectable or patch] contraception, double barrier methods, naturally or surgically sterile, strict abstinence or partner has been sterilized. If hormonal-based birth control is being used, subject or subject's sexual partner(s) must be on a stable-dose for ≥ 3 months prior to the Baseline visit and maintained at the same dosing level throughout the 9-week clinical trial.)
- Body Mass Index (BMI) over 40
Show all 44Show fewer
- A history of osteoarthritis symptoms that are completely non-responsive to non-steroidal anti-inflammatory drugs (NSAIDs) at the discretion of the Investigator
- Planned change (increase or decrease) in subject's level of physical activity (e.g., aerobic or anaerobic exercise) during the 6-week Treatment Period following randomization
- Enrollment in any trial and/or use of any Investigational Drug or device within the immediate 30-day period prior to the Baseline visit
- Enrollment in any study previously sponsored by Olatec Industries LLC, specifically Study OLT1177-01 or OLT1177-02
- Pain Related
- Does not meet pain assessment entry criteria as defined by Sponsor's pain eligibility algorithm and calculated by the study Interactive Web Response System
- Clinically significant joint (other than the knee) or general pain at Baseline, at the discretion of the Investigator
- Musculoskeletal Related
- Clinically significant, excessive effusion heat and/or redness in the target knee as determined by the Investigator
- Knock-kneed or bow-legged, as defined by a valgus or varus deformity of ≥ 15 degrees
- Radiographic evidence of osteoarthritis by Kellgren-Lawrence classification with a rating of Grade 0, 1 or 4 in the target knee, as confirmed by the Sponsor's designated rheumatologist through radiographic review of x-ray(s) taken no more than 1 year prior to the Screening visit (sharpening of the tibial spine is not considered to be an osteophyte)
- Documented history of clinically significant pain associated with osteoarthritis of the spine or hips, at the discretion of the Investigator
- Significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or chondromalacia
- Clinically significant medio-lateral and/or anterior-posterior instability, at the discretion of the Investigator
- Open surgery of the target knee within the prior year or surgery to the contralateral knee or other weight-bearing joint within the prior year, if at the discretion of the Investigator it would interfere with the study. If subject had open surgery more than one-year prior, Sponsor's designated rheumatologist must confirm that such surgery did not have any negative impact or consequence to the target knee (e.g., deformity of angle to the bone, bone on bone, locking joints, etc.)
- Arthroscopic surgery of the target knee within the prior six months
- Any acute or chronic injury, other than osteoarthritis in the target knee, that will be treated during the trial with any medication not allowed during the Treatment Period
- Prior surgery of the target knee requiring insertion of a medical device or surgical hardware (e.g., screws)
- Any major trauma or injury (including sports injuries) to the target knee in the past 12 months
- Documented history of inflammatory joint disease, including but not limited to: rheumatoid arthritis, gout, pseudogout, Paget's disease, psoriatic arthritis, ankylosing spondylitis, chronic inflammatory disease (e.g., colitis), fibromyalgia (diagnosed in accordance with ACR criteria, as applicable), articular fracture, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders (e.g., hypermobility) or collagen gene mutations
- Any planned interventional and/or surgical procedure during the 6-week Treatment Period following randomization
- Concomitant Conditions, Diseases, Medications/Therapies and Medical History Related
- Any use of Rescue Medication within 24 hours prior to the Baseline visit or use of any other pain medication within 7 days prior to Baseline visit
- Uncontrolled hypertension, defined as blood pressure ≥ 150/95 mmHg
- A history of uncontrolled and untreated diabetes mellitus with an HbA1c level > 8; or blood sugar levels that are outside of the normal range and HbA1c level > 8 is subsequently confirmed
- Any inflammatory skin condition over the target knee application area
- Use of any prohibited concomitant medications/therapies during the 7-day Washout Period or planned use of any prohibited concomitant medications/therapies during the 6 week Treatment Period
- Use of intraarticular or intramuscular steroids in the target knee within the previous 3 months or in any other joint within the previous 30 days
- Use of intraarticular hyaluronate in the target knee within the previous 6 months or in any other joint within the previous 30 days
- Current substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse (including alcoholism and/or addiction to pain medications) that is determined at the discretion of the Investigator as likely to interfere with trial assessments or recur during the trial
- Use of any systemic (oral or parenteral) corticosteroids within the prior month
- Uncontrolled psychiatric conditions (e.g., mania, depression, anxiety, substance dependence of any kind) that would impair the subject from safely participating in the trial, including completing any protocol requirements
- Evidence of cognitive impairment including dementia that may interfere with subject's ability to complete daily pain diaries requiring recall of average pain level in the past 24 hours
- Significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological or neurological disease or prior surgery that may interfere with the subject successfully completing the trial, including completing any protocol requirements as determined by the Investigator
- History of or known positive for HIV, Hepatitis B surface antigen (HBsAg) or antibodies to Hepatitis C Virus (HCV)
- Diagnosed with any form of 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 that in the opinion of the Investigator would impair the subject from safely participating in the trial and/or completing any protocol requirements
- Active infection within 3 days of the Baseline visit
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216
Clinical Trials of South Carolina
Charleston, South Carolina, 29406
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911
Avail Clinical Research
DeLand, Florida, 32720
Healthcare Research Network, Inc.
Hazelwood, Missouri, 63042
Health Awareness, Inc.
Jupiter, Florida, 33458
Sunrise Medical Research, Inc.
Lauderdale Lakes, Florida, 33319
Clinical Research Consulting, LLC
Milford, Connecticut, 06460
Coastal Carolina Research Center, Inc
Mt. Pleasant, South Carolina, 29464
Best Clinical Trial, LLC
New Orleans, Louisiana, 70115
International Clinical Research - US, LLC
Sanford, Florida, 32771
Miami Research Associates, LLC
South Miami, Florida, 33143
Omega Medical Research
Warwick, Rhode Island, 02886
About this study
Official title: A Phase 2b Randomized, Double-Blind, Vehicle-Controlled, Repeat-Dose, Multi- Center, 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 objectives of this trial are to investigate the efficacy and safety of six weeks of treatment with OLT1177 Gel in subjects with moderate to severe pain associated with osteoarthritis of the knee following cessation of pain therapy.
- Conditions
- Osteoarthritis, Pain
- Being tested
- Placebo Gel, OLT1177 Gel
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo GelDrug
6 mL of Placebo Gel administered TID for 6 weeks
OLT1177 GelDrug
6 mL of OLT1177 Gel (5%) administered TID for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo Gel | Placebo comparator | 6 mL of Placebo Gel administered TID for 6 weeks Receives: Drug: Placebo Gel |
| OLT1177 Gel | Experimental | 6 mL of OLT1177 Gel (5%) administered TID for 6 weeks Receives: Drug: OLT1177 Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on Movement
Subjects will record their level of Pain on Movement in the target knee on a 100-mm VAS scale (with anchors 0=no pain; 100=extreme pain) in response to the question, 'How do you estimate the average amount of your study knee pain while moving during your daily activities within the last 24 hours?'
Measured: Baseline to Week 6
Secondary outcomes (10)
Current Knee Pain
After completing a walk of approximately 50 feet, subjects will record their level of Current Knee Pain in the target knee on a 100-mm Visual Analog Scale (with anchors 0=no pain; 100=extreme pain) in response to the question, 'How do you estimate the amount of your study knee pain right now?'
Measured: Baseline (pre-dose) to Baseline (50-min post-dose)
WOMAC Pain Subscale
The WOMAC NRS3.1 OA Index is a validated, segregated, multidimensional, self-administered index with three independent dimensions: pain, physical function and stiffness. It is comprised of 24 questions to be answered by the subject. The pain subscale consists of 5 questions; the physical function subscale consists of 17 questions; and the joint stiffness subscale consists of 2 questions.
Measured: Baseline to Weeks 2, 4 and 6
WOMAC Physical Function Subscale
The WOMAC NRS3.1 OA Index is a validated, segregated, multidimensional, self-administered index with three independent dimensions: pain, physical function and stiffness. It is comprised of 24 questions to be answered by the subject. The pain subscale consists of 5 questions; the physical function subscale consists of 17 questions; and the joint stiffness subscale consists of 2 questions.
Measured: Baseline to Weeks 2, 4 and 6
Global Rating of Disease
Subjects will complete the assessment on a 100-mm Visual Analog Scale (with anchors 0=very good; 100=very poor) in response to the question, 'Considering all the ways osteoarthritis affects you, how well are you doing?'
Measured: Baseline to Weeks 2, 4 and 6
Current Knee Pain
After completing a walk of approximately 50 feet, subjects will record their level of Current Knee Pain in the target knee on a 100-mm Visual Analog Scale (with anchors 0=no pain; 100=extreme pain) in response to the question, 'How do you estimate the amount of your study knee pain right now?'
Measured: Baseline to Hours 2-6
WOMAC Stiffness Subscale
The WOMAC NRS3.1 OA Index is a validated, segregated, multidimensional, self-administered index with three independent dimensions: pain, physical function and stiffness. It is comprised of 24 questions to be answered by the subject. The pain subscale consists of 5 questions; the physical function subscale consists of 17 questions; and the joint stiffness subscale consists of 2 questions.
Measured: Baseline to Weeks 2, 4 and 6
Pain on Movement (VAS, in-clinic)
Subjects will record their level of Pain on Movement in the target knee on a 100-mm VAS scale (with anchors 0=no pain; 100=extreme pain) in response to the question, 'How do you estimate the average amount of your study knee pain while moving during your daily activities within the last 24 hours?'
Measured: Baseline to Weeks 2, 4 and 6
Pain on Movement (11-point NRS, diary)
All evaluations will be on the 11-point Numerical Rating Scale (with anchors 0=no pain; 100=extreme pain) and in response to the following instructions: Please put an "X" over the one number below that best describes your average study knee pain while moving during your daily activities since you woke up this morning.
Measured: Baseline through Week 6
Use of Rescue Medication
Subjects will record the amount, time/date and dose of Rescue Medication use throughout the trial.
Measured: Baseline through Week 6
Short Form 12v2 Health Survey
The SF-12v2 Health Survey is a multipurpose short-form (SF) general health survey comprised of 12 questions to measure functional health and well-being from the subject's perspective.
Measured: Baseline to Weeks 2, 4 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2015
- Study completionAug 2015
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
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olatec Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Cunningham, MD, FAAD, Study chair, Cu-Tech, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104050
- Sponsor's protocol ID
- OLT1177-03
- Status last verified
- Apr 2017
- First submitted
- 28 Mar 2014
- Last updated
- 6 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Randomized, Double-Blind, Vehicle-Controlled, Repeat-Dose, Multi- Center, 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
- NCT02104050
- Acronym / sponsor ID
- OLT1177-03
- Conditions
- Osteoarthritis, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Olatec Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 4 Apr 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 objectives of this trial are to investigate the efficacy and safety of six weeks of treatment with OLT1177 Gel in subjects with moderate to severe pain associated with osteoarthritis of the knee following cessation of pain therapy.
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 |
|---|---|---|
| Placebo Gel | Placebo comparator | Drug: Placebo Gel6 mL of Placebo Gel administered TID for 6 weeks |
| OLT1177 Gel | Experimental | Drug: OLT1177 Gel6 mL of OLT1177 Gel (5%) administered TID for 6 weeks |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age 45 to 80 years old, inclusive
- Clinical diagnosis of osteoarthritis in one target knee based on the following American College of Rheumatology (ACR) criteria:
- Symptoms associated with osteoarthritis of the knee (including pain) for ≥ 6 months prior to Screening
- Knee pain associated with osteoarthritis, which required NSAID or other therapy for ≥ 15 days during the preceding month
- Radiographic evidence of osteoarthritis by Kellgren-Lawrence classification with a rating of Grade 2 or 3 in the target knee (does not include borderline Grade 2), as confirmed by the Sponsor's designated rheumatologist through radiographic review of x-ray(s) taken no more than 1 year prior to the Screening visit. (Sharpening of the tibial spine is not considered to be an osteophyte) (See Appendix 4 for additional details)
Key exclusion criteria (44 listed)
- General
- Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential may not be entered into the study if:
- Body Mass Index (BMI) over 40
- A history of osteoarthritis symptoms that are completely non-responsive to non-steroidal anti-inflammatory drugs (NSAIDs) at the discretion of the Investigator
- Planned change (increase or decrease) in subject's level of physical activity (e.g., aerobic or anaerobic exercise) during the 6-week Treatment Period following randomization
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 |
|---|---|---|
| Placebo Gel6 mL of Placebo Gel administered TID for 6 weeks | Drug | Placebo Gel |
| OLT1177 Gel6 mL of OLT1177 Gel (5%) administered TID for 6 weeks | Drug | OLT1177 Gel |
Primary outcome
Pain on Movement
Time frame: Baseline to Week 6
Subjects will record their level of Pain on Movement in the target knee on a 100-mm VAS scale (with anchors 0=no pain; 100=extreme pain) in response to the question, 'How do you estimate the average amount of your study knee pain while moving during your daily activities within the last 24 hours?'
10 secondary outcomes
Current Knee Pain
Time frame: Baseline (pre-dose) to Baseline (50-min post-dose)
WOMAC Pain Subscale
Time frame: Baseline to Weeks 2, 4 and 6
WOMAC Physical Function Subscale
Time frame: Baseline to Weeks 2, 4 and 6
Global Rating of Disease
Time frame: Baseline to Weeks 2, 4 and 6
Current Knee Pain
Time frame: Baseline to Hours 2-6
WOMAC Stiffness Subscale
Time frame: Baseline to Weeks 2, 4 and 6
Pain on Movement (VAS, in-clinic)
Time frame: Baseline to Weeks 2, 4 and 6
Pain on Movement (11-point NRS, diary)
Time frame: Baseline through Week 6
Use of Rescue Medication
Time frame: Baseline through Week 6
Short Form 12v2 Health Survey
Time frame: Baseline to Weeks 2, 4 and 6
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 2017.
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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.
William Cunningham, MD, FAAD study chair
Cu-Tech, LLC
13 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 and Pain, run by Olatec Therapeutics, Inc. at 13 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 14 inclusion and 44 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 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Pain on Movement (time frame: Baseline to Week 6). 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 2017.