Phase 3
Completed N=285
Efficacy and Safety of VVZ-149 Injections in Patients Undergoing Laparoscopic Colectomy
Pain, Postoperative · Postoperative Pain
Source: ClinicalTrials.gov NCT05764525 ↗
Enrolled (actual)
285
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Time-weighted Sum of Pain Intensity Differences for 12 Hours Post-dose (SPID 12) — 26.83; 19.89 score on a scale*hours — p=0.0047
◆ Published Evidence
Emerging
12citations · ~12 / year
Reduction of postoperative pain and opioid consumption by VVZ-149, first-in-class analgesic molecule: A confirmatory phase 3 trial of laparoscopic colectomy.
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.
Linked Publications
-
Reduction of postoperative pain and opioid consumption by VVZ-149, first-in-class analgesic molecule: A confirmatory phase 3 trial of laparoscopic colectomy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-weighted Sum of Pain Intensity Differences for 12 Hours Post-dose (SPID 12) |
26.83; 19.89 | 0.0047 sig |
| SECONDARY Total Number of Patient-controlled Analgesia (PCA) Requests for 12 Hours Post-dose |
7.0; 17.6; 5.0; 10.1; 4.6; 8.0 | — |
| SECONDARY Total Amount of PCA and Rescue Medication Consumption for 12 Hours Post-dose |
38.6; 47.0; 24.0; 31.9; 19.1; 27.6 | — |
Eligibility Criteria
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 ≥ 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 ≥ 5 at baseline)
Data sourced from ClinicalTrials.gov (NCT05764525) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.