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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Intra-anal Oxymetazoline gel once daily |
|
| Placebo | Placebo Comparator | Intra-anal Placebo gel once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxymetazoline gel | Drug | Oxymetazoline gel applied intra-anally once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To examine the effect of Oxymetazoline gel on fecal incontinence episodes in the 8 hours following application. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (area under the curve [AUC]), peak concentration and half life time (T 1/2) of Oxymetazoline; | 4 weeks | |
| Number of participants with adverse events | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis Egyetem I. sz. Belgyógyászati Klinika | Budapest | Hungary |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Placebo gel |
| Drug |
Placebo gel applied intra-anally once daily |
|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |