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Sponsors and Collaborators: |
Pacira Pharmaceuticals, Inc Richmond Pharmacology Limited |
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Information provided by: | Pacira Pharmaceuticals, Inc |
ClinicalTrials.gov Identifier: | NCT00485667 |
A reduction in the postoperative need for opioids to enhance the recovery process and increase patient postoperative satisfaction.
Condition | Intervention | Phase |
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Postoperative Pain |
Drug: SKY0402 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Crossover Assignment |
Official Title: | Evaluation of the Effects of Therapeutic and Supra-Therapeutic Single Doses of SKY0402 Given as Subcutaneous Injection on the QT/QTc Interval in Young Healthy Volunteers. A Prospective, Randomized, Placebo- and Positive-Controlled, Double Blind, Single-Centre, Crossover Phase 1 Study. |
Estimated Enrollment: | 48 |
Study Start Date: | June 2007 |
Study Completion Date: | August 2007 |
Providing extended pain relief without the use of indwelling catheters is the basis for developing SKY0402. A formulation of bupivacaine, given as a single injection after surgery, that could provide adequate, continuous, and extended pain relief would greatly simplify postoperative pain management, reduce the need for repeated administration, and minimize break-through episodes of pain.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
At screening and Run-in period each ECG should have:
If there are outlying values in the ECGs, the consistency of these values should be confirmed as follows:
The final decision to include / not include a volunteer based on protocol ECG criteria lies with the cardiologist assessing the Run-in ECGs.
A female subject may be entered into the study if she is:
Females of childbearing potential must use one of the following methods of contraception:
Exclusion Criteria:
Subjects with vital signs measurements as follows:
United Kingdom | |
Richmond Pharmacology Ltd | |
London, United Kingdom, SW19 0RE |
Principal Investigator: | Jorg Taubel, MD MFPM | Richmond Pharmacology Limited |
Study ID Numbers: | SKY0402C105, Richmond No. C07027, EudraCT Number: 2007-001981-33 |
Study First Received: | June 11, 2007 |
Last Updated: | September 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00485667 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
pain postoperative |
Signs and Symptoms Postoperative Complications Pain Healthy Pain, Postoperative |
Pathologic Processes |