Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Laparoscopic Colorectomy

NCT02992041 | Completed Phase 2

• 1 other identifier: VVZ149-POP-P2-US002
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections. The study is designed as randomized, double-blind, parallel, placebo-controlled study.

Conditions

Post-Operative Pain

Outcome Measures

Primary Outcomes (1)

• area under the curve (AUC) of Pain Intensity

  area under the curve (AUC) of Pain Intensity using Numeric Pain Rating Scale (NRS, 0-10 at rest) measured up to 2 hours post-initiation of PCA

  0hr=start of PCA, 1hr and 2 hours

Secondary Outcomes (6)

• Opioid Consumption up to 24 hours post-dosing of study drug

  0-2, 2-4, 4-6, 6-8, 8-10, 10-12, and 12-24 hours

• Pain Intensity (Numeric Pain Rating Scale, NRS)

  0, 1, 2, 4, 6, 8, 10, 12, and 24 hours

• Global measurement of subject satisfaction with study medication

  8 and 24 hours post-initiation of PCA

• Richmond Agitation Sedation Scale (RASS)

  0, 1, 2, 4, 6, 8, 10, 12, and 24 hours post-initiation of PCA

• Respiratory Depression Assessment

  0, 1, 2, 4, 6, 8, 10, 12, 24 hours post-initiation of PCA and within 10 minutes prior to administering any rescue doses of hydromorphone

Study Arms (3)

Lower dose VVZ-149 Injections

EXPERIMENTAL

Drug: VVZ-149 Injections

Higher dose VVZ-149 Injections

EXPERIMENTAL

Drug: VVZ-149 Injections

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

VVZ-149 Injections DRUG

IV infusion of 900 or 1100 mg of VVZ-149

Also known as: Opiranserin Injections

Higher dose VVZ-149 Injections; Lower dose VVZ-149 Injections

Placebo DRUG

IV infusion of 0 mg of VVZ-149

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects undergoing planned laparoscopic colorectal surgery.
• Ability to provide written informed consent.
• Ability to understand study procedures and communicate clearly with the investigator and staff.
• American Society of Anesthesiologists (ASA) risk class of I to III.

You may not qualify if:

• \<Surgical Factors\>
• Emergency or unplanned surgery.
• Repeat operation (e.g., previous surgery within 30 days for same condition).
• Cancer-related condition causing preoperative pain in site of surgery.
• Surgical duration (from incision to end of closure) \> 5 hours.
• \<Subject Characteristics\>
• Women with childbearing potential (age 18-55) must undergo blood pregnancy test at screening and then a urine pregnancy test preoperatively on day of surgery. Women with a positive pregnancy test will be excluded. Women of childbearing potential must agree to use at least one effective contraceptive method upon enrollment and for 30 days following the last dose of the investigational product.
• Women who are pregnant or breastfeeding.
• Chronic pain diagnosis (e.g., ongoing pain at baseline with NRS ≥ 4/10).
• Unstable or poorly controlled psychiatric condition (e.g., untreated PTSD, anxiety, or depression) Subjects who take stable doses of antidepressants and anti-anxiety drugs, or procedure-related anti-anxiety drugs may be included.
• Unstable or acute medical condition (e.g., unstable angina, congestive heart failure, renal failure, hepatic failure, AIDS).
• Body weight under 55 kg.
• \<Drug, Alcohol, and Pharmacological Considerations\>
• Renal or hepatic impairment.
• History of alcohol, opiate or other drug abuse or dependence within 12 months prior to Screening (TICS alcohol/drug screen will be performed at Screening).

Sponsors & Collaborators

• Vivozon, Inc.: lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 14, 2016
• Study Start: December 27, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 26, 2018
• Last Updated: August 25, 2020

Record last verified: 2020-08

Locations

US (2)