Completed PHASE1 INTERVENTIONAL 2-arm NCT00850590

Study of Escalating Doses of NRL001 Given in Slow-release Rectal Suppositories of Different Weights

A Randomised, Placebo-controlled, Double-blind, Dose Escalation Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of Rectal Suppositories Containing Between 5 and 15 mg NRL001 or Matching Placebo for Two Different Sized Suppositories (1 g and 2 g).

Sponsor: Norgine

Conditions Incontinence

Interventions NRL001

Updated 5 times since 2017 Last updated: Dec 21, 2009 Started: Feb 28, 2009 Primary completion: Apr 30, 2009

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Incontinence and is currently completed. Norgine leads this study, which shows 5 recorded versions since 2009 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Jan 2017 — Jun 2018 [monthly]

Completed PHASE1

First recorded

Feb 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Norgine

Data source: Norgine

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Belfast, United Kingdom