Study to Investigate Safety and Response to 1 or 2 g Rectal Suppositories Containing 5 or 10 mg NRL001.
|ClinicalTrials.gov Identifier: NCT00857467|
Recruitment Status : Completed
First Posted : March 6, 2009
Last Update Posted : December 23, 2009
|Condition or disease||Intervention/treatment||Phase|
|Fecal Incontinence||Drug: NRL001||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 Start Date :||February 2009|
|Primary Completion Date :||December 2009|
Experimental: 1 g suppository
Subjects receive 5 mg NRL001, 10 mg NRL001 and placebo in a 1g rectal suppository
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.
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.
- Change in MARP after a single dose [ Time Frame: 6 hours ]
- Pharmacokinetic plasma assessment to determine systemic uptake [ Time Frame: 6 hours ]
- Adverse events [ Time Frame: 6 hours ]
- Cardiovascular parameters; heart rate and blood pressure [ Time Frame: 6 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00857467
|Department of GI Surgery, Nottingham University Hospital|
|Nottingham, United Kingdom, NG7 2UH|
|Study Director:||Hans-Jürgen Gruss, MD||Norgine|
|Principal Investigator:||John H Scholefield, MD||Nottingham University Hospital|