SCIPhase 2IN NEONCT00855283
Intranasal Administration of a Prokinetic for Bowel Evacuation in Persons With SCI
A Phase 2 study testing IN NEO, IN NEO + IN Glycopyrrolate and IV Visit in people with SCI, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- SCI
- What is being tested?
- IN NEO, IN NEO + IN Glycopyrrolate and IV Visit
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intranasal Administration of Neostigmine and Glycopyrrolate for Bowel Evacuation
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.
Read the detailed description
We have been studying the effects of spinal cord injury on the bowel for over ten years. Our data suggests that one of the fundamental consequences of spinal cord injury is a slowing of intestinal peristaltic activity, most likely as a result of down regulation of parasympathetic neural pathways. Furthermore, measures that increase parasympathetic stimulation to the bowel result in bowel evacuation and improve bowel care. In this respect, significant acute effects have been demonstrated after the intravenous administration of the cholinergic agent neostigmine (Am J Gastro 100:1560-5, 2005). Long term efficacy has also been shown using intramuscular administration of neostigmine (Gastro 128:P258, 2005). Subcutaneous administration of neostigmine is in progress at this time. Bowel evacuation also is facilitated by subcutaneous administration but often requires a second dose (30 minutes after the first). This observation is likely due to a decreased rate of absorption from this tissue compartment and a correspondingly lower peak level of neostigmine (vide infra). Given the potential cardiopulmonary toxicity of neostigmine (bradycardia and bronchoconstriction), neostigmine was administered in these studies in combination with the anticholinergic agent glycopyrrolate. We have reported that the latter selectively blocks the cardiopulmonary side effects of neostigmine without significantly decreasing the prokinetic peristaltic response. In summary, our data to date indicates that the combined administration of neostigmine and glycopyrrolate is safe after spinal cord damage and it results in predicable and prompt bowel evacuation.
- Conditions
- SCI
- Being tested
- IN NEO, IN NEO + IN Glycopyrrolate, IV Visit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN NEODrug
20 mg Neostigmine via intranasal and sublingual administration
IN NEODrug
40 mg Neostigmine via intranasal administration
IN NEODrug
60 mg Neostigmine via intranasal administration
IN NEO + IN GlycopyrrolateDrug
Intranasal or sublingual Neostigmine (at effective dose: 20, 40, or 60 mg) + 4-12 mg intranasal or sublingual Glycopyyrolate
IV VisitDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | SCI Receives: Drug: IN NEO; Drug: IN NEO + IN Glycopyrrolate; Drug: IV Visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel evacuation
Measured: <60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startSep 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mark A. Korsten, MD, Principal investigator, VA Medical Center, Bronx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855283
- Sponsor's protocol ID
- B4162C-2
- Other IDs
- KOR-11-018
- Acronym
- IN NEO
- Status last verified
- Jul 2013
- First submitted
- 2 Mar 2009
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Administration of Neostigmine and Glycopyrrolate for Bowel Evacuation
- ClinicalTrials.gov ID
- NCT00855283
- Acronym / sponsor ID
- IN NEO / B4162C-2
- Conditions
- SCI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 4 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We have been studying the effects of spinal cord injury on the bowel for over ten years. Our data suggests that one of the fundamental consequences of spinal cord injury is a slowing of intestinal peristaltic activity, most likely as a result of down regulation of parasympathetic neural pathways. Furthermore, measures that increase parasympathetic stimulation to the bowel result in bowel evacuation and improve bowel care. In this respect, significant acute effects have been demonstrated after the intravenous administration of the cholinergic agent neostigmine (Am J Gastro 100:1560-5, 2005). Long term efficacy has also been shown using intramuscular administration of neostigmine (Gastro 128:P258, 2005). Subcutaneous administration of neostigmine is in progress at this time. Bowel evacuation also is facilitated by subcutaneous administration but often requires a second dose (30 minutes after the first). This observation is likely due to a decreased rate of absorption from this tissue compartment and a correspondingly lower peak level of neostigmine (vide infra). Given the potential cardiopulmonary toxicity of neostigmine (bradycardia and bronchoconstriction), neostigmine was administered in these studies in combination with the anticholinergic agent glycopyrrolate. We have reported that the latter selectively blocks the cardiopulmonary side effects of neostigmine without significantly decreasing the prokinetic peristaltic response. In summary, our data to date indicates that the combined administration of neostigmine and glycopyrrolate is safe after spinal cord damage and it results in predicable and prompt bowel evacuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: IN NEO, Drug: IN NEO + IN Glycopyrrolate, Drug: IV VisitSCI |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IN NEO20 mg Neostigmine via intranasal and sublingual administration | Drug | Arm 1 |
| IN NEO40 mg Neostigmine via intranasal administration | Drug | Arm 1 |
| IN NEO60 mg Neostigmine via intranasal administration | Drug | Arm 1 |
| IN NEO + IN GlycopyrrolateIntranasal or sublingual Neostigmine (at effective dose: 20, 40, or 60 mg) + 4-12 mg intranasal or sublingual Glycopyyrolate | Drug | Arm 1 |
| IV Visit2mg 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. | Drug | Arm 1 |
Primary outcome
Bowel evacuation
Time frame: <60 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A. Korsten, MD principal investigator
VA Medical Center, Bronx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IN NEO, IN NEO + IN Glycopyrrolate and IV Visit in people with SCI, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel evacuation (time frame: <60 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2013.