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

Primary Purpose

Fecal Incontinence

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

NRL001

About this trial

This is an interventional treatment trial for Fecal Incontinence

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Department of GI Surgery, Nottingham University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

1 g suppository

2 g suppository

Arm Description

Subjects receive 5 mg NRL001, 10 mg NRL001 and placebo in a 1g rectal suppository

Subjects receive 5 mg NRL001, 10 mg NRL001 and placebo in a 2 g rectal suppository.

Outcomes

Primary Outcome Measures

Change in MARP after a single dose

Secondary Outcome Measures

Pharmacokinetic plasma assessment to determine systemic uptake

Adverse events

Cardiovascular parameters; heart rate and blood pressure

Full Information

NCT ID

NCT00857467

First Posted

March 5, 2009

Last Updated

December 21, 2009

Sponsor

Norgine

1. Study Identification

Unique Protocol Identification Number

NCT00857467

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Norgine

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fecal Incontinence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1 g suppository

Arm Type

Experimental

Arm Description

Subjects receive 5 mg NRL001, 10 mg NRL001 and placebo in a 1g rectal suppository

Arm Title

2 g suppository

Arm Type

Experimental

Arm Description

Subjects receive 5 mg NRL001, 10 mg NRL001 and placebo in a 2 g rectal suppository.

Intervention Type

Drug

Intervention Name(s)

NRL001

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

NRL001

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in MARP after a single dose

Time Frame

6 hours

Secondary Outcome Measure Information:

Title

Pharmacokinetic plasma assessment to determine systemic uptake

Time Frame

6 hours

Title

Adverse events

Time Frame

6 hours

Title

Cardiovascular parameters; heart rate and blood pressure

Time Frame

6 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hans-Jürgen Gruss, MD

Organizational Affiliation

Norgine

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

John H Scholefield, MD

Organizational Affiliation

Nottingham University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of GI Surgery, Nottingham University Hospital

City

Nottingham

ZIP/Postal Code

NG7 2UH

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

24499492

Citation

Simpson JA, Bush D, Gruss HJ, Jacobs A, Pediconi C, Scholefield JH. A randomised, controlled, crossover study to investigate the safety and response of 1R,2S-methoxamine hydrochloride (NRL001) on anal function in healthy volunteers. Colorectal Dis. 2014 Mar;16 Suppl 1:5-15. doi: 10.1111/codi.12541.

Results Reference

derived

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

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