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NCT02299557
A Double Blind Study to Examine the Effect of Oxymetazoline Gel on Anal Pressure and Incontinence in Spinal Cord Injury Patients
Phase 1/Phase 2 trial testing Oxymetazoline gel in Fecal Incontinence in 19 participants. Completed in 1 July 2015.
1 June 2015
Quick facts
| Lead sponsor | RDD Pharma Ltd |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 19 |
| Start date | 1 November 2014 |
| Primary completion | 1 June 2015 |
| Estimated completion | 1 July 2015 |
| Sites | 1 location across Hungary |
Drugs / interventions tested
- Oxymetazoline gel — full drug profile →
- Placebo gel
Conditions studied
- Fecal Incontinence — all drugs for Fecal Incontinence →
- Spinal Cord Injury — all drugs for Spinal Cord Injury →
Sponsor
RDD Pharma Ltd — full company profile →
Who can join
Adults 18 to 55, any sex, with Fecal Incontinence or Spinal Cord Injury. 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.
-
To examine the effect of Oxymetazoline gel on fecal incontinence episodes in the 8 hours following application.
Time frame: 4 weeks
Sponsor's own description
This is an double blinded, cross-over study to determine the effect of Oxymetazoline gel on anal resting pressure and fecal incontinence in patients with spinal cord injury. Approximately 17 subjects are expected to complete this 10 weeks study that will include two treatment periods of 4 weeks each, and one 2 weeks wash out period.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Dressings and topical agents for treating pressure ulcers.
Westby MJ, Dumville JC, Soares MO, Stubbs N, et al · · 2017 · cited 51× · PMID 28639707 · DOI 10.1002/14651858.cd011947.pub2
Verify or expand the search:
- PubMed search for NCT02299557
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Fecal Incontinence
Currently open trials in the same condition.
- NCT06532123 — Mechanisms of Improving Fecal Continence Muscles Motor Function · NA · recruiting
- NCT05998187 — Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections · Phase 3 · recruiting
- NCT06754189 — Safety and Performance of UCon Patch Electrode · NA · recruiting
- NCT06562140 — Multidimensional Examination of Patients with Colorectal and Anal Cancer · recruiting
- NCT06273046 — Treatment of Fecal Incontinence and Functional Evacuation Disorders Using Non-instrumental Biofeedback · NA · recruiting
Other RDD Pharma Ltd trials
Trials by the same sponsor.
- NCT03757403 — RDD1609 as a Treatment for Idiopathic Pruritus Ani · Phase 2 · withdrawn
- NCT03529487 — Intra-anal Oxymetazoline in Healthy Adult Volunteers · Phase 1 · unknown
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 NCT02299557 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by RDD Pharma Ltd
- Last refreshed: 26 July 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/NCT02299557.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing