Intranasal Administration of a Prokinetic for Bowel Evacuation in Persons With SCI

Summary

DWE (difficulty with evacuation) is a common and an important quality of life issue after spinal cord injury. Not only is the management DWE time-consuming and unpleasant, but the results are often suboptimal in terms of complications such as incontinence and impaction. Bowel care regimens after spinal cord injury have not changed in any significant fashion in many years. The usual strategies for attaining bowel evacuation involve dietary manipulation (e.g., high fiber diets and hydration), thrice weekly laxative administration (senna and cascara) and thrice weekly anorectal instillation of cathartics (enemas and suppositories). Bowel care can be quite time consuming (greater than 2 hours in many instances) and may also require extensive nursing care. Finally, incomplete evacuation could contribute to fecal incontinence that has significant morbidity in these patients.

In preliminary studies performed at the JJPVAMC, IV, IM, and subcutaneous injection of neostigmine combined with glycopyrrolate were demonstrated to be highly effective to promote bowel evacuation in the SCI population. In an effort to provide a more realistic administration of this procedure, we propose to test the intranasal spray injection of neostigmine and glycopyrrolate for safety and efficacy.

Conditions

• SCI

Interventions

DRUG

IN NEO

20 mg Neostigmine via intranasal and sublingual administration

DRUG

IN NEO

40 mg Neostigmine via intranasal administration

DRUG

IN NEO

60 mg Neostigmine via intranasal administration

DRUG

IN NEO + IN Glycopyrrolate

Intranasal or sublingual Neostigmine (at effective dose: 20, 40, or 60 mg) + 4-12 mg intranasal or sublingual Glycopyyrolate

DRUG

IV Visit

2mg NEO and .4mg GLY given intravenously to see if the subject responds to the intervention. If they respond, then they will proceed to the IN portion of the study.

Sponsors & Collaborators

• US Department of Veterans Affairs

  lead FED

Principal Investigators

• Mark A. Korsten, MD · VA Medical Center, Bronx

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-09-30

Primary Completion

2013-06-30

Completion

2013-06-30

Countries

• United States

Study Locations