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

NCT00893607 | Completed Phase 1

• 1 other identifier: NRL001-01/2006 (SUPP)
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

• Change in mean anal resting pressure (MARP)

  Up to 6 hours post-dose

Secondary Outcomes (2)

• Pharmacokinetics of NRL001 in plasma

  Up to 6 hours post-dose

• Monitoring of blood pressure and heart rate

  Up to 6 hours post-dose

Study Arms (2)

Intra-anal

EXPERIMENTAL

The first 12 subjects were administered 10mg NRL001 as a slow release suppository into the anal canal.

Drug: NRL001

Rectal

EXPERIMENTAL

The second 12 subjects were administered 10mg NRL001 as a slow release rectal suppository.

Drug: NRL001

Interventions

NRL001 DRUG

10mg NRL001 was administered as a slow release suppository

Also known as: Methoxamine Hydochloride

Intra-anal; Rectal

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No previous history of ano-rectal conditions/ diseases
• No history of cardiovascular disease
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Norgine: lead

Study Sites (1)

Division of GI Surgery, University Hospital - Queens Medical Centre

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• John H Scholefield

  University Hospital - Queens Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 5, 2009
• First Posted: May 6, 2009
• Study Start: April 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 6, 2009

Record last verified: 2009-05

Locations

GB (1)