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

NCT ID: NCT00893607

Last Updated: 2009-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2007-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intra-anal

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

Group Type: EXPERIMENTAL

NRL001

Intervention Type: DRUG

10mg NRL001 was administered as a slow release suppository

Rectal

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

Group Type: EXPERIMENTAL

NRL001

Intervention Type: DRUG

10mg NRL001 was administered as a slow release suppository

Interventions

NRL001

10mg NRL001 was administered as a slow release suppository

Intervention Type: DRUG

Other Intervention Names

Methoxamine Hydochloride

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Norgine

INDUSTRY

Sponsor Role: lead

Responsible Party

Norgine Ltd

Principal Investigators

John H Scholefield

Role: PRINCIPAL_INVESTIGATOR

University Hospital - Queens Medical Centre

Locations

Division of GI Surgery, University Hospital - Queens Medical Centre

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

NRL001-01/2006 (SUPP)

Identifier Type: -

Identifier Source: org_study_id