Efficacy and Safety of VVZ-149 Injections in Patients Undergoing Laparoscopic Colectomy (NCT05764525) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of VVZ-149 Injections in Patients Undergoing Laparoscopic Colectomy
South Korea285 participantsStarted 2021-07-19
Plain-language summary
The purpose of this phase 3 study is to evaluate the efficacy and safety of VVZ-149 Injections for the treatment of postoperative pain following laparoscopic colectomy.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Men and women who are at least 18 years of age
* Female subjects who are not pregnant or breastfeeding
* Subjects undergoing a planned first laparoscopic colectomy
* Subjects classified in American Society of Anesthesiologists (ASA) risk class of I or II
* Subjects who report the pain intensity ā„ 5 on the NRS measured after surgery
* Subjects who have the ability to understand study procedures and communicate clearly with the investigator and staff
* Subjects who provide written informed consent prior to participation in the study
Key Exclusion Criteria:
* Subjects undergoing emergency or unplanned surgery
* Subjects who had a previous laparoscopic colectomy procedure, or who had any laparoscopic resection procedure
* Subjects with pre-existing conditions causing preoperative pain at the site of surgery
* Female subjects who are pregnant or breastfeeding
* Diagnosis of chronic pain (e.g., persistent pain with the intensity of NRS ā„ 5 at baseline)
What they're measuring
1
Time-weighted Sum of Pain Intensity Differences for 12 Hours Post-dose (SPID 12)