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

This study has been completed.
Sponsor:
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT00857467
First received: March 5, 2009
Last updated: December 21, 2009
Last verified: December 2009
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


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
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 g suppository
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.
Experimental: 2 g suppository
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:

  1. No previous history of ano-rectal conditions or diseases
  2. No history of cardiovascular disease
  3. 18 to 60 years of age
  4. 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:

  1. 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
  2. Use of monoamine oxidase inhibitors presently or within the last 2 weeks before study participation
  3. Use of any medication in the last 30 days applied to the anus and/or via the rectum
  4. 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.
  5. Regular intake of more than 21 units of alcohol per week
  6. 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
  7. Presence of diabetes mellitus
  8. History or symptoms of thyroid diseases, including hypo- or hyperthyroidism
  9. Pregnant or lactating females
  10. History of any clinically relevant allergy
  11. 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
  12. Volunteers whom the Investigator feels would not comply with the requirements of the trial
  13. Volunteers who have been exposed to more than 5 mSv of ionising radiation in the last 12 months.
  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: NCT00857467

Locations
United Kingdom
Department of GI Surgery, Nottingham University Hospital
Nottingham, United Kingdom, NG7 2UH
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 by Norgine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vice President Clinical Development, Norgine
ClinicalTrials.gov Identifier: NCT00857467     History of Changes
Other Study ID Numbers: NRL001-01/2008 (SUM)
Study First Received: March 5, 2009
Last Updated: December 21, 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

ClinicalTrials.gov processed this record on October 16, 2014