NCT00111046

Brief Summary

The purpose of this study is to assess post operative pain following the insertion of radioactive plaque for choroidal melanoma in patients after receiving either ibuprofen or tramadol.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2001

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2001

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2005

Completed
Last Updated

November 10, 2005

Status Verified

May 1, 2005

First QC Date

May 16, 2005

Last Update Submit

November 9, 2005

Conditions

Choroidal MelanomaMelanomaEye Neoplasms

Keywords

Pain ReliefChoroidal melanomaplaque radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Compare levels of pain

Interventions

IbuprofenDRUG
TramadolDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients that are admitted for undergoing plaque radiotherapy for choroidal melanoma would be approached to participate in this study.
  • They should be adults who are of a sound frame of mind to give an informed consent to participate.

You may not qualify if:

  • Patients less than 18 years of age
  • Patients of unsound mind not capable of giving informed consent
  • Active peptic ulcer disease, asthma, renal dysfunction, warfarin therapy, hypothyroidism history of epilepsy, pregnancy, breastfeeding and hypersensitivity to either products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Liverpool University Hospital

Liverpool, Merseyside, L8 0RU, United Kingdom

Location

MeSH Terms

Conditions

Uveal MelanomaMelanomaEye Neoplasms

Interventions

IbuprofenTramadol

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsNeoplasms by SiteEye DiseasesUveal DiseasesSkin NeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCyclohexanolsHexanolsFatty AlcoholsAlcoholsDimethylaminesMethylaminesAminesLipids

Study Officials

  • Bertil Damato

    Royal Liverpool University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 16, 2005

First Posted

May 17, 2005

Study Start

February 1, 2001

Study Completion

February 1, 2004

Last Updated

November 10, 2005

Record last verified: 2005-05

Locations

GB(1)