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Study of VVZ-149 regarding its effectiveness and safety in treating pain after camera-based colon surgery


Title A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Dose Finding Study to Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Laparoscopic Colorectal Surgery
Therapeutic Area Post-Operative Pain
Principal Investigator Arnel Almeda, MD
Min Age 18 Years
Max Age 75 Years
Gender Both
Contact Arnel Almeda
617-636-9392
More Information https://clinicaltrials.gov/ct2/show/NCT02992041

Overview

We are studying a medication called VVZ-149. We want to know how well it works for pain, after colon surgery that uses a camera-based approach. We will also be looking for any bad reactions that people may have to it. Patients in the study receive VVZ-149 for a total of about 11 hours. They also receive the usual pain medicines.

Some pain medicines have a lot of side effects, like opioids. These medicines include morphine, hydromorphone, and heroin. When we give less opioid, patients have fewer side effects, like dangerously slow breathing or addiction. However, there are only a few medicines that help as well for pain. The medicine we are studying works on pain in a different way. VVZ-149 is not an opioid.

So far, there have been a few early studies. In animals, VVZ-149 has been shown to work as well as morphine for pain. It has also been given to people. When healthy people took it, they sometimes complained of feeling sick to one’s stomach, dizzy, or sleepy. It has also been given to patients who have had stomach surgery. These patients needed less opioid. They did not have any more problems than healthy people did.

Study Details

Inclusion Criteria

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

Exclusion Criteria

  • Emergency or unplanned surgery.
  • Chronic pain condition (e.g., ongoing pain at baseline of 4 or more on a 10-point scale).
  • Unstable or poorly controlled psychiatric condition or medical condition (e.g. untreated PTSD, poorly-controlled anxiety or depression, unstable angina, congestive heart failure, renal failure, hepatic failure, AIDS).

Study Requirements

The medicine and its effects will be studied over three visits. These visits overlap with the usual care for surgery. Visit 1 is the screening before surgery that happens within 30 days before surgery. Visit 2 is part of the subject’s hospital admission for surgery. The study intervention and follow-up is finished in the first 32 hours. Visit 3 is the return appointment that happens two to four weeks after treatment. The subject sees the surgeon at this time to see how he or she is progressing after the surgery.

During the first visit, the patient will have a full evaluation for the surgery. This evaluation includes the history and physical, psychological screening, electrocardiogram (EKG) and blood draw (approximately 15mL). During the second visit, the subject will undergo their scheduled surgery. At this time, the subject will be put in 1 of 3 groups. Two of these groups will receive the study medication. One group will not receive it. That group takes a placebo. A placebo looks like the real medicine but it does not have any effect. The actual study medicine and the placebo look like a small bag of clear water. The patient will not know what group he or she is in. To make sure all patients are comfortable, they all get as much standard opioid pain medication, as they need. The study team will speak to the patient 8 times in the first 24 hours after waking up from surgery. We want to understand the patient’s experience with the study medication. We will ask about pain, satisfaction, sleepiness, breathing, and feeling sick to one’s stomach. The patient will have blood taken five times, for a total volume of about 35mL. To make the patient more comfortable, we plan to use an intravenous line, so that the patient will not need to get stuck with separate needles. There will also be 4 heart exams (EKGs). Lastly, during the third visit, the patient comes back to the hospital to see the surgeon. At that time the patient will answer follow-up questions regarding their experience. He or she will also get another heart exam (EKG) and blood draw (about 15mL).

There will be no planned radiology scans.