Evolution Research Group | Endeavor Clinical Trials
Status and phase
Conditions
Treatments
About
This clinical study is a randomized, double-blind, double-dummy, parallel group, multi-center, active and placebo-controlled trial evaluating the analgesic efficacy and safety of NTM-001 in subjects with moderately severe postoperative pain after bunionectomy surgery.
This study is designed to compare the efficacy of NTM-001 to placebo. Intravenous (IV) morphine serves as an active comparator to determine assay sensitivity and support assessment of opioid-level analgesia for NTM-001. Effectiveness, safety, and tolerability parameters will be descriptively compared between treatment arms.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
History of peptic ulcer disease, GI bleeding, perforation, or active peptic ulcer disease.
History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
History of, or suspected or confirmed, cerebrovascular bleeding, hemorrhagic diathesis, or incomplete hemostasis.
Increased risk of bleeding at the discretion of the Investigator based on prior/concomitant disease, laboratory values, medication or surgical complications.
Clinical laboratory values reflecting at least mild renal insufficiency as indicated by a creatinine clearance ≤89 mL/min.
Risk for renal failure due to volume depletion at the discretion of the Investigator.
Concomitant use of aspirin or NSAIDs.
History of seizure disorder or epilepsy, as suggested by the presence of any of the following:
History of alcohol or drug abuse in the Investigator's judgement based on subject history and physical examination.
Significant chronic obstructive pulmonary disease or cor pulmonale, a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression.
At least moderately impaired hepatic function (Child-Pugh >6), or subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values greater than 3 times the upper limit of normal (ULN).
Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days.
The subject is not on a stable dose (at least 2 weeks prior to Screening Visit) of medications that may lower the seizure threshold (e.g., anti-psychotic agents) or which impact the serotonergic system (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants).
Evidence of significant anemia (indicated by hemoglobin concentration ≤8 g/dL).
Evidence of active infections that may spread to other areas of the body (e.g., osteomyelitis, pyogenic infection of the hip, Hepatitis B or C, or other overt infections) or a history of human immunodeficiency virus (HIV) 1 or 2.
History of malignancy within 2 years prior to the start of the study, with the exception of basal cell and cutaneous squamous cell carcinoma.
History of systemic lupus erythematosus, antiphospholipid syndrome, vasculitis, vasculopathy, or deep vein thrombosis.
Uncontrolled or poorly controlled post-traumatic stress disorder, generalized anxiety disorder, depression, psychiatric, or other significant medical conditions.
Chronic systemic steroid therapy, excluding inhalers or a 1-time intraoperative dose, within 4 weeks before screening.
History of pending litigation due to pain or disability.
Clinically significant disease that, in the Investigator's opinion, may affect efficacy or safety assessments.
Employees of the Investigator or study site with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, including family members of the employees or the Investigator.
Received an experimental drug or used an experimental medical device within 30 days before screening or have participated in a previous study of ketorolac.
Contraindications to, or history of allergy or hypersensitivity to ketorolac and/or morphine and their excipients.
A positive COVID-19 test (rapid antigen test) or COVID-19 related symptoms at screening and/or at check in of Visit 2 (Surgical Period).
Subjects who are planning on receiving a COVID-19 vaccine during the study duration.
Primary purpose
Allocation
Interventional model
Masking
360 participants in 3 patient groups, including a placebo group
Loading...
Central trial contact
Roshna Noor
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal