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Efficacy of Udenafil After Radical Resection for Sigmoid Colon and Rectal Cancer

NCT ID: NCT00607282

Last Updated: 2012-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-01-31

Brief Summary

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The purpose of this study is to evaluate the efficacy of Udenafil (Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea) in treatment of erectile dysfunction after radical resection for sigmoid colon and rectal cancer. In this study, the efficacy of Udenafil will be evaluated in treatment for patient with chronic erectile dysfunction, which developed after radical resection for sigmoid and rectal cancer and continues 12 months after the surgery.

Detailed Description

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Post-pelvic surgery erectile dysfunction is of much interest to those performing sigmoid colon and rectal cancer surgery and their patients. Erectile dysfunction has been recognized to develop from damage to pelvic parasympathetic nerve, which are especially vulnerable during anterior rectal dissection. There may be also a contribution of psychological factors from the presence of stoma and fear of recurrent cancer. Recently, several studies reported that erectile dysfunction after rectal excision for rectal cancer was completely reversed or satisfactorily improved using oral erectile dysfunction drugs. Udenafil is a new phosphodiesterase type 5 (PDE 5) inhibitor for erectile dysfunction. Prior studies have also demonstrated a selectivity profile for udenafil that is similar to Sildenafil (viagra®) and tadalafil (Cialis®). But unlike tadalafil (Cialis®), it does not significantly inhibit the PDE11 isozyme and not produce significant myalgia. back pain, or leg pain.

This prospective, randomized study was designed to evaluate the efficacy of Udenafil treatment in treatment of erectile dysfunction after radical resection for sigmoid colon and rectal cancer. In order to conduct this study, enrolled patients will be randomly attributed to Udenafil group or placebo group.

Conditions

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Erectile Dysfunction Sigmoid Colon Cancer Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

normal control group

Group Type PLACEBO_COMPARATOR

Udenafil

Intervention Type DRUG

oral administration of Udenafil, prn(2hours before anticipated intercourse, 8 times/months)

Udenafil

oral administration of placebo for Udenafil (Dong-A Pharmaceutical co., Ltd, Seoul, Korea)

Group Type EXPERIMENTAL

Udenafil

Intervention Type DRUG

oral administration of Udenafil, prn(2hours before anticipated intercourse, 8 times/months)

Interventions

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Udenafil

oral administration of Udenafil, prn(2hours before anticipated intercourse, 8 times/months)

Intervention Type DRUG

Other Intervention Names

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Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea

Eligibility Criteria

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Inclusion Criteria

* • Male patients between 19-70 years old in good general health

* Patient willing to treat postoperative erectile dysfunction and participate in the study
* Patient who understands and accepts to sign the informed consent form
* Patient who received radical resection for sigmoid colon and rectal cancer. : erectile dysfunction was developed following operation, not preoperatively
* Scores of IIEF-5 measured at 12 months after surgery is 16 or less

Exclusion Criteria

* • Documented problem of preoperative erectile dysfunction

* Past history of myocardial infarction, cerebrovascular disease
* Under administration of nitrate
* Liver dysfunction (SGOT or SGPT 100 IU/L or more)
* Kidney dysfunction (serum Creatinine 3mg/dl or more)
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sung-Bum Kang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sung-Bum Kang, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Department of Surgery, Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUBH-GS-CR2

Identifier Type: -

Identifier Source: secondary_id

B-0610-038-004

Identifier Type: -

Identifier Source: org_study_id