A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee
NCT ID: NCT02944448
Last Updated: 2020-10-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
761 participants
INTERVENTIONAL
2016-09-30
2017-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Eligible patients will be randomized to receive either CR845 or placebo in a 2:1 ratio. Every patient will be started on a 1-mg dose of CR845 or matching placebo. During the post-randomization Titration-to-Effect period, the dose of study drug may be increased to 2.5 mg or 5 mg in a double-blind fashion. Patients may know their dose is being changed but will not know whether they were randomization to active study drug or placebo. Approximately 330 patients will be enrolled in this study.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of the Safety and Effectiveness of Orally Administered CR845 in Patients With Osteoarthritis of the Hip or Knee
NCT02524197
Study of REGN475 in Patients With Pain Due to Osteoarthritis of the Knee or Hip
NCT02447276
A Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of KA34 in Subjects With Knee Osteoarthritis
NCT03133676
A Safety and Tolerability Study of JNJ-42160443 in Patients With Moderate to Severe, Chronic Knee Pain From Osteoarthritis
NCT01094262
A Phase 3 Efficacy and Safety Study of Intra-articular CNTX-4975-05 (Capsaicin) vs Placebo in Subjects With OA Knee Pain
NCT03429049
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study schedule consists of a Screening Period (up to 14 days), a blinded 4- week Titration-to-Effect Period with weekly visits, a blinded 4-week Maintenance Treatment Period at the optimal dose level determined for each patient, and a 1-week Follow-up Period.
Eligible patients will be randomized to receive either CR845 or placebo in a 2:1 ratio. Randomization will be stratified based on a patient's primary OA joint (knee vs. hip). Every patient will be started on a 1-mg dose of CR845 or matching placebo. During the post-randomization Titration-to-Effect period, the dose of study drug may be increased to 2.5 mg or 5 mg in a double-blind fashion.
Patients may know their dose is being changed but will not know whether they were randomized to active study drug or placebo. Approximately 330 patients will be enrolled in this study.
During the Screening, Titration-to-Effect and Follow-up Period, pain intensity scores will be obtained at specified time points. Blood sampling and safety assessments will be conducted during this period as well.
The use of rescue medication for the treatment of any pain (including but not limited to headache, menstrual cramps, or non-target joint pain) during the study will be discussed with the patients at the Screening Visit. Acetaminophen is the only allowable rescue medication for pain beginning from Day -5 until the end of the Maintenance Treatment Period. Starting at the Screening Visit Acetaminophen will be provided as 325-mg tablets and its use (number of tablets taken in the previous 24 hours) will be reported each evening in the patient diary.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CR845 tablet 1 mg
Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal.
CR845 tablet 1 mg
CR845 tablets will be provided as 1 mg enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose and treatment.
CR845 tablet 2.5 mg
Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal.
CR845 tablet 2.5 mg
CR845 tablets will be provided as 2.5 mg enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose and treatment.
CR845 tablet 5 mg
Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal.
CR845 tablet 5 mg
CR845 tablets will be provided as 5 mg enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose and treatment.
Placebo tablet
Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal.
Placebo tablet
Placebo tablets will be provided as enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose and treatment.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CR845 tablet 1 mg
CR845 tablets will be provided as 1 mg enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose and treatment.
CR845 tablet 2.5 mg
CR845 tablets will be provided as 2.5 mg enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose and treatment.
CR845 tablet 5 mg
CR845 tablets will be provided as 5 mg enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose and treatment.
Placebo tablet
Placebo tablets will be provided as enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose and treatment.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Is able to speak, read, and communicate clearly in English or Spanish; is able to understand the study procedures.
3. Male or female ≥ 25 years of age.
4. Body mass index (BMI) ≤ 40 kg/m2.
5. Has OA of the hip or knee according to American College of Rheumatology (ACR) criteria.
6. Reports an average pain intensity level ≥ 5 in the index joint at Screening on a 0-10 NRS scale.
7. Is either opioid-naïve (defined as taking \< 10 mg a day of morphine equivalent 14 days prior to screening) or opioid-experienced. If receiving opioid analgesic medication for OA, patients must be on a stable dose ≤ 40 mg of morphine equivalents for 14 days prior to screening.
8. Willing to discontinue currently used pain medications beginning 5 days prior to the Baseline Visit and throughout the study. Acetaminophen use is allowed. (Section 8.8)
9. If female:
1. Of childbearing potential - the patient must be willing to practice an acceptable form of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence from sexual intercourse) for the duration of treatment and for at least 3 days following the last dose of study drug.
2. Of non-childbearing potential - the patient must be surgically or biologically sterile (hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or postmenopausal for at least 1 year).
10. If male, the patient must be surgically or biologically sterile. If not sterile, the patient must agree to use an acceptable form of birth control with a heterosexual partner (as described in inclusion criterion #9) or abstain from sexual relations during the treatment period and for 3 days following the last dose of study drug.
11. Is free of other physical, mental, or medical conditions that, in the opinion of the Investigator, would make study participation inadvisable.
12. Reports a daily pain intensity score in the index joint ≥ 5 (on a 0-10 NRS scale) during 4 or more of the last 7 days prior to randomization, with 2 consecutive days ≥ 5 occurring just prior to randomization
A patient will be eligible for enrollment if the following criteria are met:
1. Voluntarily provides written informed consent to participate in the study prior to any study procedures.
2. Is able to speak, read, and communicate clearly in English or Spanish; is able to understand the study procedures.
3. Male or female ≥ 25 years of age.
4. Body mass index (BMI) ≤ 40 kg/m2.
5. Has OA of the hip or knee according to American College of Rheumatology (ACR) criteria.
6. Reports an average pain intensity level ≥ 5 in the index joint at Screening on a 0-10 NRS scale.
7. Is either opioid-naïve (defined as taking \< 10 mg a day of morphine equivalent 14 days prior to screening) or opioid-experienced. If receiving opioid analgesic medication for OA, patients must be on a stable dose ≤ 40 mg of morphine equivalents for 14 days prior to screening.
8. Willing to discontinue currently used pain medications beginning 5 days prior to the Baseline Visit and throughout the study. Acetaminophen use is allowed. (Section 8.8)
9. If female:
1. Of childbearing potential - the patient must be willing to practice an acceptable form of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence from sexual intercourse) for the duration of treatment and for at least 3 days following the last dose of study drug.
2. Of non-childbearing potential - the patient must be surgically or biologically sterile (hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or postmenopausal for at least 1 year).
10. If male, the patient must be surgically or biologically sterile. If not sterile, the patient must agree to use an acceptable form of birth control with a heterosexual partner (as described in inclusion criterion #9) or abstain from sexual relations during the treatment period and for 3 days following the last dose of study drug.
11. Is free of other physical, mental, or medical conditions that, in the opinion of the Investigator, would make study participation inadvisable.
12. Reports a daily pain intensity score in the index joint ≥ 5 (on a 0-10 NRS scale) during 4 or more of the last 7 days prior to randomization, with 2 consecutive days ≥ 5 occurring just prior to randomization
Exclusion Criteria
2. Has received an intra-articular injection of corticosteroids or hyaluronic acid in the index joint within 3 months prior to the Screening Visit.
3. Has started a new medication for chronic illness within 30 days prior to the Screening Visit.
4. Is receiving opioid analgesic treatment for OA of the hip or knee at a dose \> 40 mg of morphine equivalent.
5. Uses antipsychotics, antiepileptics, sedatives, hypnotics, or antianxiety agents, selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants with a dose change \<30 days prior to day 1 of the study.
6. Has a history or current diagnosis of substance dependence (except caffeine or nicotine) or alcohol abuse, according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
7. Has a positive urine drug screen for drugs of abuse at Screening.
8. Has been diagnosed with a condition of hyperhidrosis (excessive sweating) or primary hypodipsia (a reduced sense of thirst).
9. Has a history (within 6 months) of clinically meaningful orthostatic changes in vital signs OR, at Screening, has a decrease in systolic blood pressure by \> 20 mm Hg or a decrease in diastolic blood pressure by 10 mm Hg together with an increase in heart rate of \> 30 beats per minute when transitioning from supine to standing measurements.
10. Has a medical condition (e.g., a cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine \[adrenal hyperplasia\], immunologic, dermatologic, neurologic, oncologic, or psychiatric) or a significant laboratory abnormality that, in the Investigator's opinion, would jeopardize the safety of the patient or is likely to confound the study measurements.
11. Has had any gastric bypass surgery (for weight loss).
12. Has a corrected QT interval of \>450 msec in males, \>470 msec in females, or clinically significant abnormality on screening ECG.
13. Has a serum sodium level \> 143 mmol/L at Screening.
14. Has impaired renal function indicated by serum creatinine \> 2 × the reference upper limit of normal (ULN).
15. Has a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 × the reference ULN, or total bilirubin \> 2 × the ULN at Screening.
16. Has, in the opinion of the Investigator, any clinical signs of dehydration or hypovolemia (e.g., symptomatic hypotension) or associated laboratory abnormalities (e.g., elevated hematocrit or elevated blood urea nitrogen \[BUN\] \> 1.5 × the reference ULN) at Screening.
17. Has taken opioid or non-opioid pain medication (e.g., nonsteroidal anti-inflammatory drugs \[NSAIDs\] such as naproxen or cyclooxygenase-2 inhibitors) within 5 days prior to study drug administration. Acetaminophen use is allowed. (Section 8.8)
18. Has received another investigational drug within 30 days prior to Baseline or has planned to participate in another clinical trial while enrolled in this study.
25 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cara Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joseph Stauffer, DO, MBA
Role: STUDY_DIRECTOR
Cara Therapeutics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cara Therapeutics Study Site
Birmingham, Alabama, United States
Cara Therapeutics Study Site
Peoria, Arizona, United States
Cara Therapeutics Study Site
Phoenix, Arizona, United States
Cara Therapeutics Study Site
Carmichael, California, United States
Cara Therapeutics Study Site
San Diego, California, United States
Cara Therapeutics Study Site
Tustin, California, United States
Cara Therapeutics Study Site
Homestead, Florida, United States
Cara Therapeutics Study Site
Jupiter, Florida, United States
Cara Therapeutics Study Site
Lake Worth, Florida, United States
Cara Therapeutics Study Site
Miami, Florida, United States
Cara Therapeutics Study Site
Oldsmar, Florida, United States
Cara Therapeutics Study Site
Orlando, Florida, United States
Cara Therapeutics Study Site
Plantation, Florida, United States
Cara Therapeutics Study Site
South Miami, Florida, United States
Cara Therapeutics Study Site
Tampa, Florida, United States
Cara Therapeutics Study Site
Savannah, Georgia, United States
Cara Therapeutics Study Site
Hazelwood, Missouri, United States
Cara Therapeutics Study Site
Omaha, Nebraska, United States
Cara Therapeutics Study Site
Las Vegas, Nevada, United States
Cara Therapeutics Study Site
Berlin, New Jersey, United States
Cara Therapeutics Study Site
Binghamton, New York, United States
Cara Therapeutics Study Site
Rochester, New York, United States
Cara Therapeutics Study Site
Cincinnati, Ohio, United States
Cara Therapeutics Study Site
Cincinnati, Ohio, United States
Cara Therapeutics Study Site
Oklahoma City, Oklahoma, United States
Cara Therapeutics Study Site
Duncansville, Pennsylvania, United States
Cara Therapeutics Study Site
Charleston, South Carolina, United States
Cara Therapeutics Study Site
Charleston, South Carolina, United States
Cara Therapeutics Study Site
Greenville, South Carolina, United States
Cara Therapeutics Study Site
Austin, Texas, United States
Cara Therapeutics Study Site
Dallas, Texas, United States
Cara Therapeutics Study Site
Plano, Texas, United States
Cara Therapeutics Study Site
Plano, Texas, United States
Cara Therapeutics Study Site
San Antonio, Texas, United States
Cara Therapeutics Study Site
Charlottesville, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CR845-CLIN2002-PO
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.