The Safety and Dose Response to Single Anal Doses of NRL001
NCT ID: NCT06593743
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
44 participants
INTERVENTIONAL
2002-12-31
2013-11-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Single Doses of 10 mg NRL001 Applied as a Suppository to the Anal Canal or Rectum
NCT00893607
Study to Investigate Safety and Response to 1 or 2 g Rectal Suppositories Containing 5 or 10 mg NRL001.
NCT00857467
Study of Escalating Doses of NRL001 Given in Slow-release Rectal Suppositories of Different Weights
NCT00850590
A Multi-centre, Phase II, Double-blind, Randomised, Placebo-controlled, Parallel Group, Dose-ranging Study in Patients With Faecal Incontinence; to Evaluate the Efficacy, Safety and Tolerability of Locally Applied NRL001 Over an 8 Week Treatment Period
NCT01656720
Safety, Tolerability, Pharmacodynamic and Pharmacokinetics of a Single Rectal Application of 10 mg NRL001 in Elderly Subjects
NCT01099683
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study consists of four parts, which evaluate different NRL001 concentrations and sites of application. Treatments consist of a single local application of either 0.3%, 1% or 3% w/w NRL001 gel applied peri-anally, of either 1% or 3% w/w NRL001 gel applied intra-anally, or 1% w/w NRL001 administered rectally. In addition, a 10 mg NRL001-containing suppository applied to the rectum is assessed.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
FACTORIAL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Perianal NRL001 Gel 3 strengths
A single peri-anal application of NRL001 0.3%, 1%, 3% gel in stepwise dose ascending fashion.
Perianal NRL001 Gel 3 strengths
A single application of 0.3%, 1.0%, 3.0% NRL001 gel in stepwise dose ascending fashion.
Intraanal NRL001 Gel 2 strengths
A single intra-anal application of 3% or 1% NRL001 gel.
Intraanal NRL001 Gel 2 strengths
A single application of 3.0% or 1.0% Gel
Intrarectal NRL001 Gel
A single intra-rectal application of 1% NRL001 gel.
Intrarectal NRL001 Gel
A single application of 1.0% Gel
NRL001: 10mg suppository
One 10mg NRL001 suppository applied to rectum.
NRL001: 10mg suppository
NRL001 10mg suppository applied to rectum.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Perianal NRL001 Gel 3 strengths
A single application of 0.3%, 1.0%, 3.0% NRL001 gel in stepwise dose ascending fashion.
Intraanal NRL001 Gel 2 strengths
A single application of 3.0% or 1.0% Gel
Intrarectal NRL001 Gel
A single application of 1.0% Gel
NRL001: 10mg suppository
NRL001 10mg suppository applied to rectum.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* No history of heart disease.
* 18 to 75 years of age.
* Males and females but 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 any medication in the last 30 days applied to the anus and/or via the rectum (exception: participation in Part A, Part B or Part C of NRL001-01/2002(HV)
* Regular intake of more than 21 units of alcohol per week.
* Pregnant females.
* Breast feeding mothers.
* 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 be compliant with the requirements of the trial.
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Norgine
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hans-Jürgen Gruss, MD
Role: STUDY_DIRECTOR
Norgine
John H Scholefield, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital - Queens Medical Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital - Queens Medical Centre
Nottingham, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NRL001-01/2002 (HV)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.