- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00893607
Effect of Single Doses of 10 mg NRL001 Applied as a Suppository to the Anal Canal or Rectum
May 5, 2009 updated by: Norgine
Proof of Concept Study in Healthy Volunteers to Investigate the Safety and Response to a Single Dose of 10mg Methoxamine (NRL001) Applied Locally Using a Suppository to the Anal Canal or Rectum
Study to assess the effects of 10mg NRL001 on mean anal resting pressure (MARP) when administered as a slow release suppository applied to the anal canal or rectum.
In addition, the pharmacokinetics of NRL001 in plasma, adverse events, and any changes in heart rate or blood pressure were to be assessed.
Study Overview
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nottingham, United Kingdom, NG7 2UH
- Division of GI Surgery, University Hospital - Queens Medical Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- No previous history of ano-rectal conditions/ diseases
- No history of cardiovascular disease
- 18 to 75 years of age
- Males and females (pre-menopausal females of child-bearing potential must be using adequate contraceptive methods and have a negative pregnancy test before the start of the study)
Exclusion Criteria:
- Use of medication in the last 30 days with a vasodilatory activity
- Use of monoamine oxidase inhibitors (MAOI) presently or within the last two weeks before study participation
- Use of any medication in the last 30 days applied to the anus and/or via the rectum (exception: participation in NRL001-01/2006 (SUPP) for previous dosing into the anal canal)
- Application of any unlicensed medication within the previous 3 months (exception: participation in NRL001-01/2006 (SUPP))
- Regular intake of more than 21 units of alcohol per week
- History or any evidence of cardiovascular disease including ischaemic heart disease and hypertension (defined on examination: systolic blood pressure greater than 160mmHg or diastolic blood pressure greater than 90mmHg; based on at least two separate readings), peripheral vascular disease or Raynaud's syndrome
- Presence of diabetes mellitus
- History or symptoms of thyroid diseases, including hypo- or hyperthyroidism
- Pregnant females
- Breast feeding mothers
- Presence of concomitant gastrointestinal diseases or disorders, such as significant abdominal symptoms and haemorrhoids but also any significant organ (e.g. renal, hepatic or cardiac) dysfunction
- Volunteers whom the investigator feels would not be compliant with the requirements of the trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intra-anal
The first 12 subjects were administered 10mg NRL001 as a slow release suppository into the anal canal.
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10mg NRL001 was administered as a slow release suppository
Other Names:
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Experimental: Rectal
The second 12 subjects were administered 10mg NRL001 as a slow release rectal suppository.
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10mg NRL001 was administered as a slow release suppository
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in mean anal resting pressure (MARP)
Time Frame: Up to 6 hours post-dose
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Up to 6 hours post-dose
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Pharmacokinetics of NRL001 in plasma
Time Frame: Up to 6 hours post-dose
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Up to 6 hours post-dose
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Monitoring of blood pressure and heart rate
Time Frame: Up to 6 hours post-dose
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Up to 6 hours post-dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John H Scholefield, University Hospital - Queens Medical Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
August 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
May 5, 2009
First Submitted That Met QC Criteria
May 5, 2009
First Posted (Estimate)
May 6, 2009
Study Record Updates
Last Update Posted (Estimate)
May 6, 2009
Last Update Submitted That Met QC Criteria
May 5, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Diseases
- Rectal Diseases
- Fecal Incontinence
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Adrenergic alpha-1 Receptor Agonists
- Methoxamine
Other Study ID Numbers
- NRL001-01/2006 (SUPP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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