Effect of Single Doses of 10 mg NRL001 Applied as a Suppository to the Anal Canal or Rectum

This study has been completed.
Sponsor:
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT00893607
First received: May 5, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Fecal Incontinence
Drug: NRL001
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Norgine:

Primary Outcome Measures:
  • Change in mean anal resting pressure (MARP) [ Time Frame: Up to 6 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics of NRL001 in plasma [ Time Frame: Up to 6 hours post-dose ] [ Designated as safety issue: No ]
  • Monitoring of blood pressure and heart rate [ Time Frame: Up to 6 hours post-dose ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: April 2007
Study Completion Date: December 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intra-anal
The first 12 subjects were administered 10mg NRL001 as a slow release suppository into the anal canal.
Drug: NRL001
10mg NRL001 was administered as a slow release suppository
Other Name: Methoxamine Hydochloride
Experimental: Rectal
The second 12 subjects were administered 10mg NRL001 as a slow release rectal suppository.
Drug: NRL001
10mg NRL001 was administered as a slow release suppository
Other Name: Methoxamine Hydochloride

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893607

Locations
United Kingdom
Division of GI Surgery, University Hospital - Queens Medical Centre
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Norgine
Investigators
Principal Investigator: John H Scholefield University Hospital - Queens Medical Centre
  More Information

No publications provided

Responsible Party: Dr Hans-Jürgen Gruss, Norgine Ltd
ClinicalTrials.gov Identifier: NCT00893607     History of Changes
Other Study ID Numbers: NRL001-01/2006 (SUPP)
Study First Received: May 5, 2009
Last Updated: May 5, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Methoxamine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014