NCT00893100

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2009

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 5, 2009

Completed
Last Updated

May 5, 2009

Status Verified

May 1, 2009

Enrollment Period

1.2 years

First QC Date

April 19, 2009

Last Update Submit

May 2, 2009

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Reduction of Pain

    daily in one week

Study Arms (1)

Diltiazem

EXPERIMENTAL
Drug: Diltiazem

Interventions

DiltiazemDRUG

2%,3 times daily

Diltiazem

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sina General Hospital

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Pain

Interventions

Diltiazem

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Farshad Jalili, Resident

    Sina Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 19, 2009

First Posted

May 5, 2009

Study Start

October 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

May 5, 2009

Record last verified: 2009-05

Locations

IR(1)