Study to Investigate Safety and Response to 1 or 2 g Rectal Suppositories Containing 5 or 10 mg NRL001. - Full Text View

Sponsored by:	Norgine
Information provided by:	Norgine
ClinicalTrials.gov Identifier:	NCT00857467

Purpose

This is a healthy volunteer three-way crossover study. A total of 12 subjects will receive three single administrations of 1 g rectal suppositories (containing either 5 mg NRL001, 10 mg NRL001 or matching placebo), with a washout period of at least 7 days between dosings. A further 12 subjects will receive three single administrations of 2 g rectal suppositories (containing either 5 mg NRL001, 10 mg NRL001 or matching placebo), again with a 7 day washout period between dosings. The pharmacodynamic response, pharmacokinetics and safety profile will be determined.

Condition	Intervention	Phase
Fecal Incontinence	Drug: NRL001	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	Randomised, Double-Blind, Single Dose, Three-Way, Cross-Over Study to Investigate the Safety and Response to 1g or 2g Rectal Suppositories Containing 5 mg or 10 mg 1R,2S-Methoxamine Hydrochloride [NRL001] or Matching Placebo

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence

U.S. FDA Resources

Further study details as provided by Norgine:

Primary Outcome Measures:

Change in MARP after a single dose [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetic plasma assessment to determine systemic uptake [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
Cardiovascular parameters; heart rate and blood pressure [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	36
Study Start Date:	February 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 g suppository: Experimental Subjects receive 5 mg NRL001, 10 mg NRL001 and placebo in a 1g rectal suppository	Drug: NRL001 Subjects receive single doses of 5 mg NRL001, 10 mg NRL001 and placebo in a 1 g rectal suppository, with a 7-day washout period between dosing.
2 g suppository: Experimental Subjects receive 5 mg NRL001, 10 mg NRL001 and placebo in a 2 g rectal suppository.	Drug: NRL001 Subjects receive single doses of 5 mg NRL001, 10 mg NRL001 and placebo in a 2 g rectal suppository, with a 7-day washout period between dosing.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

No previous history of ano-rectal conditions or diseases
No history of cardiovascular disease
18 to 60 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, or use of any medication currently or within the last 30 days which the Investigator believes may affect the study participation or results
Use of monoamine oxidase inhibitors presently or within the last 2 weeks before study participation
Use of any medication in the last 30 days applied to the anus and/or via the rectum
Application of any unlicensed medication within the previous 3 months or participation in any other research study in the last three months which involved being paid a disturbance allowance; having an invasive procedure (e.g. venepuncture >50ml, endoscopy) or exposure to ionising radiation.
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 160 mmHg or diastolic blood pressure greater than 90 mmHg; 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 or lactating females
History of any clinically relevant allergy
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 comply with the requirements of the trial
Volunteers who have been exposed to more than 5 mSv of ionising radiation in the last 12 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857467

Contacts

Contact: Claudio Pediconi

01895 453652

cpediconi@norgine.com

Locations

United Kingdom
Department of GI Surgery, Nottingham University Hospital	Recruiting
Nottingham, United Kingdom, NG7 2UH
Principal Investigator: Scholefield H John, MD

Sponsors and Collaborators

Norgine

Investigators

Study Director:	Hans-Jürgen Gruss, MD	Norgine
Principal Investigator:	John H Scholefield, MD	Nottingham University Hospital

More Information

No publications provided

Responsible Party:	Norgine ( Vice President Clinical Development )
Study ID Numbers:	NRL001-01/2008 (SUM)
Study First Received:	March 5, 2009
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00857467 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Signs and Symptoms
Fecal Incontinence
Digestive System Diseases
Urologic Diseases
Urination Disorders

Gastrointestinal Diseases
Methoxamine
Urinary Incontinence
Intestinal Diseases
Rectal Diseases

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Fecal Incontinence
Digestive System Diseases
Urologic Diseases

Urination Disorders
Gastrointestinal Diseases
Urinary Incontinence
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 10, 2009