Study to Investigate Safety and Response to 1 or 2 g Rectal Suppositories Containing 5 or 10 mg NRL001.
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|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|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|