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

NCT00855283 | Completed Phase 2

• 2 other identifiers: B4162C-2KOR-11-018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Bowel evacuation

  <60 min

Study Arms (1)

Arm 1

EXPERIMENTAL

SCI

Drug: IN NEO; Drug: IN NEO + IN Glycopyrrolate; Drug: IV Visit

Interventions

IN NEO DRUG

20 mg Neostigmine via intranasal and sublingual administration

Arm 1

IN NEO + IN Glycopyrrolate DRUG

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

Arm 1

IV Visit DRUG

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.

Arm 1

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Incomplete or complete SCI
• Tetraplegia or paraplegia
• Males or females
• Age 18 (no upper age limit)
• Excess time for bowel evacuation (\> 60 minutes per bowel training session)

You may not qualify if:

• Persons with SCI who do not require do not require additional bowel care or have "normal bowel function"
• Known hypersensitivity to neostigmine or glycopyrrolate
• History of mechanical obstruction of the intestine or urinary tract.
• Myocardial infarction within less than 6 months of trial.
• Hemodynamic instability
• Potential for pregnancy. (Women who are sexually active and of childbearing potential (i.e. not surgically sterile or at least 2 year postmenopausal) must be have a negative serum pregnancy test and to have utilized one of the following methods of contraception prior to screening: barrier (condom, diaphragm with spermicide) intrauterine device, or tubal ligation beginning at least 30 days prior; hormonal (oral, injectable, transdermal, or implanted) beginning at least 3 months prior; or vasectomized partner for at least the prior 6 months. Subjects must agree to maintain these contraceptive methods through the completion of the study.)
• Lactating/nursing females
• Patients who develop significant bradycardia (HR\<42 bpm) or other significant anticholinergic symptoms (e.g., severe cramps, dry mouth, etc.) any time during the study will be discontinued.
• Concurrent participation in other clinical trials (within 30 days).
• Use of concurrent medications that affect cardiac output (e.g. tricyclics, beta blockers, etc.)
• Fluctuating use of concurrent medications (should be stable for 3-4 weeks before and no changes anticipated throughout the study).
• History of reduced cardiac output (via history and ECG) in addition to myocardial infarction and hemodynamic instability.
• Concurrent history of peripheral vascular disease, kidney disease, etc.
• Asthma or other broncho-constrictive disorders.
• Hemoglobin level \< 12 g/dL

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Location

Study Officials

• Mark A. Korsten, MD

  VA Medical Center, Bronx

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2009
• First Posted: March 4, 2009
• Study Start: September 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 24, 2013

Record last verified: 2013-07

Locations

US (1)