A Phase 1 Study of Intraoperative Administration of CA-008 for the Correction of Hallux Valgus De… (NCT03307837) | Clinical Trial Compass
CompletedPhase 1
A Phase 1 Study of Intraoperative Administration of CA-008 for the Correction of Hallux Valgus Deformity
United States40 participantsStarted 2017-11-02
Plain-language summary
This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose, sequential-group Phase 1 study. The study will be conducted utilizing a cohort design, with sequential groups of 8 subjects. Within each dose cohort, 6 subjects will be randomized to active, and 2 will be randomized to placebo.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female aged 18 - 65 years old, inclusive.
✓. Planning to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures.
✓. Be American Society of Anesthesiology (ASA) physical Class 1 or 2.
✓. In good health and capable of undergoing a bunionectomy under regional anesthesia.
✓. No additional planned surgeries other than a bunionectomy during the course of the study.
✓. Male subjects must be either sterile (surgically or biologically), or commit to an acceptable method of birth control while participating in the study.
✓. Female subjects are eligible only if all of the following apply:
✓. Not pregnant (female subject of child bearing potential must have a negative serum pregnancy tests at screening and negative urine pregnancy test before surgery);
Exclusion criteria
✕. Subjects with a history of hypertension, cardiovascular disease and a history of cerebrovascular events.
✕. Subjects with concurrent painful conditions that may require analgesic treatment during the study period, or, in the opinion of the Investigator, may confound post-operative pain assessments.
✕. Have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months of study treatment initiation.
✕. Have a known allergy or intolerance to the following medications or related substances: capsaicin, chili peppers, propofol, bupivacaine, benzodiazepines, midazolam, oxycodone, or ondansetron.
✕. Have a clinically significant abnormal clinical laboratory test value according to the judgment of the investigator.
✕. Have, as determined by the investigator or the study's medical monitor, a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.
✕. Use concurrent therapy that could interfere with the evaluation of efficacy or safety, such as any drugs which, in the investigator's opinion, may exert significant analgesic properties or act synergistically with CA-008.
✕. Use of disallowed pain medications within 2 days prior to Day 1 (NSAIDs, COX-2 inhibitors, tramadol, ketamine, clonidine, gabapentin, pregabalin, or cannabinoids).