Neostigmine Route for Acute Colonic Pseudo Obstruction

NCT04951726 | Unknown Phase 4 FDA Drug

• 1 other identifier: 20-07318
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Neostigmine is commonly used for medical treatment of acute colonic pseudo obstruction, however, the ideal route of administration has not been determined. Though IV push works rapidly, it is likely associated with the most side effects. This study will compare the efficacy and side effect profile of 2 potential routes of administration: IV push and subcutaneous.

Conditions

Ogilvie Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of patients with radiographic resolution of colonic pseudo obstruction

  Number of patients who have cecal diameter \<9 cm AND transverse diameter \<6 cm on abdominal x-ray within 24h of initiation of neostigmine therapy.

  24 hours

Secondary Outcomes (2)

• Number of patients with recurrence of colonic pseudo obstruction

  7 days

• Number of patients with adverse medication reactions

  24 hours

Study Arms (2)

IV push

ACTIVE COMPARATOR

2 mg slow intravenous injection over five minutes repeated q12hr until resolution for up to 24 hours. (4 mg total in 24 hours)

Drug: Neostigmine

subcutaneous

EXPERIMENTAL

1.0 mg subcutaneous repeated q8hr until resolution for up to 24 hours (3.0 mg total in 24 hours)

Drug: Neostigmine

Interventions

Neostigmine DRUG

cholinesterase inhibitor

Also known as: Bloxierz, Vagostigmin, Prostigmin

IV push; subcutaneous

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with radiologically confirmed acute colonic pseudo obstruction (ACPO).
• Plain abdominal radiograph or computed tomography imaging
• Cecal diameter of \>9 cm or transverse colon diameter of \>6 cm
• Distal obstruction ruled out on imaging (Contrast enema, endoscopy, CT scan)

You may not qualify if:

• Patients with previous neostigmine administration during current hospitalization
• Patients with prior attempt at endoscopic decompression on this admission.
• Patients with base-line heart rate of less than 60 beats per minute or on beta blocker medication
• Patients with systolic blood pressure of less than 90 mm Hg
• Signs of bowel perforation, with peritoneal signs on physical examination or free air on radiographs
• Active bronchospasm requiring medication
• Treatment with prokinetic drugs such as cisapride or metoclopramide in the 24 hours before evaluation
• A history of colon cancer or partial colonic resection
• Signs concerning for colonic obstruction
• Active gastrointestinal bleeding
• Pregnancy
• Serum creatinine concentration of more than 3 mg per deciliter (265μmol per liter).

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Los Angeles University of Southern California Medical Center

Los Angeles, California, 90004, United States

RECRUITING

Related Publications (8)

• DeMets DL, Lan KK. Interim analysis: the alpha spending function approach. Stat Med. 1994 Jul 15-30;13(13-14):1341-52; discussion 1353-6. doi: 10.1002/sim.4780131308.

  PMID: 7973215 BACKGROUND

• Frankel A, Gillespie C, Lu CT, Hewett P, Wattchow D. Subcutaneous neostigmine appears safe and effective for acute colonic pseudo-obstruction (Ogilvie's syndrome). ANZ J Surg. 2019 Jun;89(6):700-705. doi: 10.1111/ans.15265. Epub 2019 May 13.

  PMID: 31083785 BACKGROUND

• Ponec RJ, Saunders MD, Kimmey MB. Neostigmine for the treatment of acute colonic pseudo-obstruction. N Engl J Med. 1999 Jul 15;341(3):137-41. doi: 10.1056/NEJM199907153410301.

  PMID: 10403850 BACKGROUND

• Kram B, Greenland M, Grant M, Campbell ME, Wells C, Sommer C. Efficacy and Safety of Subcutaneous Neostigmine for Ileus, Acute Colonic Pseudo-obstruction, or Refractory Constipation. Ann Pharmacother. 2018 Jun;52(6):505-512. doi: 10.1177/1060028018754302. Epub 2018 Jan 23.

  PMID: 29359574 BACKGROUND

• Ilban O, Cicekci F, Celik JB, Bas MA, Duman A. Neostigmine treatment protocols applied in acute colonic pseudo-obstruction disease: A retrospective comparative study. Turk J Gastroenterol. 2019 Mar;30(3):228-233. doi: 10.5152/tjg.2018.18193.

  PMID: 30541715 BACKGROUND

• van der Spoel JI, Oudemans-van Straaten HM, Stoutenbeek CP, Bosman RJ, Zandstra DF. Neostigmine resolves critical illness-related colonic ileus in intensive care patients with multiple organ failure--a prospective, double-blind, placebo-controlled trial. Intensive Care Med. 2001 May;27(5):822-7. doi: 10.1007/s001340100926.

  PMID: 11430537 BACKGROUND

• Sgouros SN, Vlachogiannakos J, Vassiliadis K, Bergele C, Stefanidis G, Nastos H, Avgerinos A, Mantides A. Effect of polyethylene glycol electrolyte balanced solution on patients with acute colonic pseudo obstruction after resolution of colonic dilation: a prospective, randomised, placebo controlled trial. Gut. 2006 May;55(5):638-42. doi: 10.1136/gut.2005.082099. Epub 2005 Nov 23.

  PMID: 16306137 BACKGROUND

• Vogel JD, Feingold DL, Stewart DB, Turner JS, Boutros M, Chun J, Steele SR. Clinical Practice Guidelines for Colon Volvulus and Acute Colonic Pseudo-Obstruction. Dis Colon Rectum. 2016 Jul;59(7):589-600. doi: 10.1097/DCR.0000000000000602. No abstract available.

  PMID: 27270510 BACKGROUND

MeSH Terms

Conditions

Colonic Pseudo-Obstruction

Interventions

Neostigmine

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Pseudo-Obstruction; Ileus; Intestinal Obstruction

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Meghan Lewis, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan Wlodarczyk, md

CONTACT

7143579599; jordan.wlodarczyk@med.usc.edu

Meghan Lewis, MD

CONTACT

3108014070; meghan.lewis@med.usc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Surgery

Model Details: Prospective randomized non-inferiority trial 2 Arms: 1. 1.0 mg subcutaneous repeated q8hr until resolution for up to 24 hours (3.0 mg total in 24 hours) 2. 2 mg slow intravenous injection over five minutes repeated q6hr until resolution for up to 24 hours. (8 mg total in 24 hours) (CONTROL GROUP)

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: July 7, 2021
• Study Start: February 4, 2022
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)