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NCT00972998
An Open Label Study to Examine the Effect of Coated Phenylephrine Suppositories on Anal Pressure in Healthy Subjects
Phase 1/Phase 2 trial testing Phenyephrine in Incontinence in 8 participants. Completed in 1 December 2009.
1 December 2009
Quick facts
| Lead sponsor | RDD Pharma Ltd |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Enrollment | 8 |
| Start date | 1 September 2009 |
| Primary completion | 1 December 2009 |
| Estimated completion | 1 December 2009 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- Phenyephrine — full drug profile →
Conditions studied
- Incontinence — all drugs for Incontinence →
Sponsor
RDD Pharma Ltd — full company profile →
Who can join
Adults 18 to 55, any sex, with Incontinence. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The primary efficacy parameter is change in Resting Anal Pressure from baseline.
Time frame: 8 hours
Sponsor's own description
This is an open label, dose-finding study. Approximately 8 healthy subjects will be participating in this study. A screening will be used to determine subject suitability for inclusion in the trial. Subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one day treatment period. During this period, 4 anal manometric studies will take place. Study medication (Coated Phenylephrine suppositories at various doses) will be administered at pre-determined intervals.
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:
- PubMed search for NCT00972998
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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- NCT03757403 — RDD1609 as a Treatment for Idiopathic Pruritus Ani · Phase 2 · withdrawn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 NCT00972998 (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 RDD Pharma Ltd
- Last refreshed: 28 December 2009
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/NCT00972998.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing