Evaluation of Pain Reduction After Hemorrhoidectomy With Use of Diltiazim Ointment 2%

This study has been completed.

First Received: April 19, 2009 Last Updated: May 2, 2009 History of Changes

Sponsored by:	Tehran University of Medical Sciences
Information provided by:	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00893100

Purpose

The purpose of this study is to evaluate the effectiveness of diltiazem ointment 2 percent in reducing pain after hemorrhoidectomy.

Condition	Intervention	Phase
Pain	Drug: Diltiazem	Phase IV

Drug Information available for: Verapamil Diltiazem hydrochloride Dexverapamil Diltiazem Diltiazem malate Verapamil hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Evaluation of Pain Reduction After Hemorrhoidectomy With Use of Diltiazim Ointment 2%

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:

Reduction of Pain [ Time Frame: daily in one week ] [ Designated as safety issue: Yes ]

Enrollment:	1
Study Start Date:	October 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Diltiazem: Experimental	Drug: Diltiazem 2%,3 times daily

Detailed Description:

Pain after hemorrhoidectomy remains a major postsurgical complication.Therefore pain management in patients is an important goal.Many studies have focused on surgical techniques,preoperative and postoperative regimes.We assessed a randomised double blind placebo-controlled trial to evaluate the effect of diltiazem ointment after surgery.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients with grade 3 or 4 hemorrhoid who underwent Milligan-Morgan surgery.

Exclusion Criteria:

Patients with a history of heart disease, blood pressure, orthostatic hypertension, hemorrhoidal surgery,or those who had previous adverse effect from calcium channel blocker drugs and also those who were pregnant.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893100

Locations

Iran, Islamic Republic of
Sina General Hospital
Tehran, Iran, Islamic Republic of

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

Principal Investigator:

Farshad Jalili, Resident

Sina Hospital

More Information

No publications provided

Responsible Party:	( Bagher Larijani )
Study ID Numbers:	724
Study First Received:	April 19, 2009
Last Updated:	May 2, 2009
ClinicalTrials.gov Identifier:	NCT00893100 History of Changes
Health Authority:	United States: Food and Drug Administration; Iran: Ministry of Health

Study placed in the following topic categories:

Calcium, Dietary
Vasodilator Agents
Verapamil
Diltiazem
Calcium Channel Blockers

Pain
Anti-Arrhythmia Agents
Cardiovascular Agents
Antihypertensive Agents

Additional relevant MeSH terms:

Membrane Transport Modulators
Vasodilator Agents
Verapamil
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Diltiazem

Calcium Channel Blockers
Anti-Arrhythmia Agents
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009