NCT06593730 is a Phase 1 clinical trial of NRL001 cream 0.5%w/w in Faecal Incontinence, sponsored by Norgine.

Who is sponsoring NCT06593730?

NCT06593730 is sponsored by Norgine.

What drugs are being tested in NCT06593730?

Interventions in NCT06593730: NRL001 cream 0.5%w/w, NRL001 cream 0.75%w/w, NRL001 cream 1.0%w/w, NRL001 cream 1.5%w/w, NRL001 cream 2.0%w/w, NRL001 cream 2.5%w/w.

What condition does NCT06593730 study?

NCT06593730 studies Faecal Incontinence.

Is NCT06593730 still recruiting?

NCT06593730 is currently completed. Last updated 10 September 2024.

Last reviewed 2024-09-10 · How we verify

NCT06593730

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Double-blind, Placebo-controlled, Randomised, Parallel-group Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Twice Daily Intra-anal Application of NRL001-cream for 14 Days.

Completed Phase 1 Last updated 10 September 2024

What this trial tests

Phase 1 trial testing NRL001 cream 0.5%w/w in Faecal Incontinence in 72 participants. Completed in 1 September 2007.

Timeline

1 August 2007

Primary endpoint
1 August 2007

1 September 2007

Quick facts

Lead sponsor	Norgine
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	72
Start date	1 August 2007
Primary completion	1 August 2007
Estimated completion	1 September 2007

Drugs / interventions tested

NRL001 cream 0.5%w/w — full drug profile →
NRL001 cream 0.75%w/w — full drug profile →
NRL001 cream 1.0%w/w
NRL001 cream 1.5%w/w — full drug profile →
NRL001 cream 2.0%w/w — full drug profile →
NRL001 cream 2.5%w/w — full drug profile →

Conditions studied

Faecal Incontinence — all drugs for Faecal Incontinence →

Sponsor

Norgine — full company profile →

Who can join

Adults 35 to 60, any sex, with Faecal Incontinence. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Recumbent and standing blood pressure and pulse rate
Time frame: 17 days
BP and pulse taken lying and standing at screening, on control day and profiling days
Ambulatory 24 hour BP monitoring
Time frame: 17 days
Ambulatory 24 hour BP monitoring on control day and profiling days
12-lead digital resting ECG
Time frame: 17 days
12-lead digital resting ECG at screening, on control day and profiling days
3-lead ambulatory 24 hour ECG monitoring
Time frame: 17 days
24 hour HOLTER monitoring at screening, on control day and profiling days

Sponsor's own description

The study is being conducted to evaluate the safety and tolerability after single and repeated twice daily intra-anal applications of 1mL NRL001 cream in stepwise increasing concentrations.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Faecal Incontinence

Currently open trials in the same condition.

NCT07126327 — Peristeen Light Explorative Clinical Investigation · NA · recruiting
NCT06143072 — CArE for OAsI Study: Care Pathways and Anorectal Evaluation for OASI Associated Incontinence · recruiting
NCT06601985 — Exploring the Effect of Colonic J-pouch in Anorectal Preservation Surgery for Ultra-low Rectal Cancer. · active not recruiting
NCT05245565 — Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer · recruiting
NCT04918329 — Functional Digestive Disorders Observatory · recruiting

Other Norgine trials

Trials by the same sponsor.

NCT07218523 — A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years · Phase 3 · recruiting
NCT05174845 — Real Word Evidence With 1L Polyethylene Glycol (PEG)+ Ascorbic Acid in Iberia · completed
NCT03437265 — A Pharmacokinetic Study of PLENVU® in Healthy Subjects · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06593730 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Norgine
Last refreshed: 10 September 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06593730.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing