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Sponsors and Collaborators: |
The Hospital for Sick Children Duchesnay Inc. |
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Information provided by: | The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT00405288 |
The purpose of this study is to evaluate the fetal safety of topical application of Proctofoam-HC®, an antihemorrhoidal, in the third trimester of pregnancy.
Condition | Intervention | Phase |
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Hemorrhoids Pregnancy |
Drug: Proctofoam-HC® |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study |
Official Title: | The Safety of Proctofoam-HC in the Third Trimester of Pregnancy |
Estimated Enrollment: | 400 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | November 2009 |
Hemorrhoids are a frequent condition in pregnancy. The rate is increased as pregnancy progresses, and they affect up to 24% of pregnant women in the third trimester. Complications of untreated hemorrhoids include bleeding, prolapse, soiling, discharge with perianal irritation and itching, and in severe cases, severe pain and venous engorgement which could even lead to thrombosis and infarction. Hemorrhoids are treated with a variety of suppositories and gels, based on analgesic and anti-inflammatory effects. The safety of these antihemorrhoidal products has not yet been documented in pregnant women.
Proctofoam-HC® has been on the Canadian market for 25 years. It combines the anti-inflammatory action of hydrocortisone with the surface anesthetic effect of pramoxine HCl. It is approved for temporary relief of anorectal inflammation, pruritus, pain and swelling associated with haemorrhoids, fissures, pruritus ani, cryptitis, proctitis and postoperative pain. We hypothesize that local application of Proctofoam-HC® in the third trimester of pregnancy is safe for the mother and fetus.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gideon Koren, MD | 416-813-5778 | gkoren@sickkids.ca |
Canada, Ontario | |
The Hospital for Sick Children | Recruiting |
Toronto, Ontario, Canada, M5G 1X8 | |
Contact: Gideon Koren, MD 416 813 5778 gkoren@sickkids.ca | |
Principal Investigator: Gideon Koren, MD | |
Sub-Investigator: Arthur Staroselsky, MD | |
Mount Sinai Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 1X5 | |
Contact: Paul Bernstein, MD 416-586-4800 ext 5236 pbernstein@mtsinai.on.ca | |
Principal Investigator: Paul Bernstein, MD |
Principal Investigator: | Gideon Koren, MD | The Hospital for Sick Children, Toronto Canada |
Study ID Numbers: | 1000008482 |
Study First Received: | November 28, 2006 |
Last Updated: | November 28, 2006 |
ClinicalTrials.gov Identifier: | NCT00405288 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Hemorrhoids Pregnancy antihemorrhoidal Proctofoam infants |
Anti-Inflammatory Agents Hydrocortisone Digestive System Diseases Cortisol succinate Gastrointestinal Diseases |
Vascular Diseases Hemorrhoids Hydrocortisone acetate Intestinal Diseases Rectal Diseases |
Anti-Inflammatory Agents Hydrocortisone Cortisol succinate Gastrointestinal Diseases Vascular Diseases Intestinal Diseases Rectal Diseases |
Pharmacologic Actions Digestive System Diseases Therapeutic Uses Hemorrhoids Cardiovascular Diseases Hydrocortisone acetate |