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NCT00420797
A Double-blind, Randomised, Placebo-controlled Study to Evaluate Topical 10% Phenylephrine Gel in the Management of Ileal Pouch Anal Anastomosis (IPAA)-Related Faecal Incontinence
Phase 3 trial testing 10% Phenylephrine hydrochloride gel in Faecal Incontinence. Withdrawn.
Quick facts
| Lead sponsor | S.L.A. Pharma AG |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Start date | 1 February 2007 |
| Estimated completion | 1 November 2007 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- 10% Phenylephrine hydrochloride gel
Conditions studied
- Faecal Incontinence — all drugs for Faecal Incontinence →
Sponsor
S.L.A. Pharma AG — full company profile →
Who can join
18 and older, any sex, with Faecal Incontinence. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- The primary efficacy variable will be the change from baseline to the end of study in the faecal incontinence score (St Mark's)
Sponsor's own description
The aim of the study is to test the hypothesis that topical application of phenylephrine improves faecal continence and quality of life in subjects with passive faecal incontinence after ileo-anal pouch construction.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00420797
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Faecal Incontinence
Currently open trials in the same condition.
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- 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
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Other S.L.A. Pharma AG trials
Trials by the same sponsor.
- NCT04273997 — Metronidazole Ointment in Non-healing Pilonidal Sinus Wounds · Phase 2 · unknown
- NCT04335032 — EPA-FFA to Treat Hospitalised Patients With COVID-19 (SARS-CoV-2) · Phase 3 · unknown
- NCT03806426 — Effect of EPA-FFA on Polypectomy in Familial Adenomatous Polyposis · Phase 3 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00420797 (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 S.L.A. Pharma AG
- Last refreshed: 18 May 2015
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/NCT00420797.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing