Neostigmine + Glycopyrrolate for Neurogenic Bowel
Trial Summary
Do I have to stop taking my current medications for the trial?
Yes, you may need to stop taking certain medications. The trial excludes participants currently treated with cholinesterase inhibitors or anti-depressants, and those taking medications that could result in adverse reactions with neostigmine and/or glycopyrrolate. A study physician will determine if your medications are compatible.
What data supports the idea that Neostigmine + Glycopyrrolate for Neurogenic Bowel is an effective treatment?
The available research does not provide specific data on the effectiveness of Neostigmine + Glycopyrrolate for Neurogenic Bowel. The studies focus on the method of delivering drugs through the skin using iontophoresis, which is a technique that uses a small electric current to help drugs pass through the skin. While this method has shown promise in delivering other drugs effectively, such as insulin in diabetic rats, there is no direct evidence in the provided information about its effectiveness for treating Neurogenic Bowel with Neostigmine + Glycopyrrolate.12345
What safety data exists for Neostigmine + Glycopyrrolate using a wireless iontophoresis device?
The provided research does not directly address the safety data for Neostigmine + Glycopyrrolate using a wireless iontophoresis device. However, it discusses the general safety and efficacy of iontophoresis for drug delivery, highlighting potential side effects like skin trauma associated with current density and total current passed. Techniques to mitigate these side effects are proposed, such as optimizing drug formulation and controlling pH. Additionally, studies on other drugs using iontophoresis, like insulin, show negligible cytotoxicity and good biocompatibility without skin irritation, suggesting a potential for safe application in similar contexts.12467
Is the Wireless Iontophoresis Device a promising treatment for delivering drugs?
What is the purpose of this trial?
Persons with spinal cord injury (SCI) have neurogenic bowel disorders which is associated with significant morbidity. The negative impact of bowel complications is often at the top of the list of problems reported by persons with SCI. Despite the magnitude of the problem of bowel dysfunction in persons with SCI, and the associated reduction in quality of life, this condition has yet to be effectively treated. The investigators have developed a novel dual drug combination to elicit a safe and predictable bowel evacuation (BE).The ability to move the bowel contents along to the rectum was severely impaired primary because of poor gut contractions on the left side of the colon, as shown by our team of investigators. To address this problem, a dual medication combination (neostigmine and glycopyrrolate) was developed that safely and predictably caused the bowel to empty after delivering these drugs into a vein (intravenously) or into the muscle bed (intramuscularly). Because no one likes needles, and because of the practical limits of administering medications on a routine basis by the use of needles, especially in persons with SCI because of their other health considerations, the investigators have devised a new approach: driving these medications across the skin and into the circulation of the body by applying an electrical current that is too small to feel (iontophoresis).The proposed research project to determine the safety of positively charged compounds (e.g., vitamin B12, NEO, and GLY) administered transcutaneously by the prototype wireless ION device and to compare the pharmacokinetic profiles of transcutaneous administration of NEO and GLY by the wireless ION device to a commercially available wired ION device. The potential administration of any number of other positively charged agents by this wireless prototype may be a clinically relevant outcome of this work. The ability to use a wireless ION device is far more practical for patients to use, especially those with SCI, which will permit the self-administration of these agents in the home setting to induce a bowel evacuation.
Research Team
Christopher P Cardozo, M.D.
Principal Investigator
James J. Peters Veterans Affairs Medical Center
Eligibility Criteria
This trial is for individuals with spinal cord injury who experience neurogenic bowel disorders, including bowel incontinence and constipation. Participants should be those seeking a non-invasive method to induce bowel evacuation.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive transdermal administration of vitamin B12, neostigmine, and glycopyrrolate using wireless and wired ION devices over three consecutive days
Follow-up
Participants are monitored for safety and effectiveness after treatment, including recording of heart rate, bowel sounds, blood pressure, and adverse symptoms
Treatment Details
Interventions
- Transdermal Administration by a Novel Wireless Iontophoresis Device
Transdermal Administration by a Novel Wireless Iontophoresis Device is already approved in United States for the following indications:
- Neurogenic bowel disorders in persons with spinal cord injury
Find a Clinic Near You
Who Is Running the Clinical Trial?
James J. Peters Veterans Affairs Medical Center
Lead Sponsor