NCT00349401

Brief Summary

The purpose of this study is to determine how the drug ketorolac, when given with the spinal morphine, affects pain.

Trial Health

10
At Risk

Trial Health Score

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

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
Last Updated

November 6, 2017

Status Verified

May 1, 2009

First QC Date

July 5, 2006

Last Update Submit

November 1, 2017

Conditions

Pain

Keywords

painchronic painmorphineketorolac

Outcome Measures

Primary Outcomes (2)

  • VAS pain.

  • Primary analysis will be the comparison between ketorolac and placebo groups.

Secondary Outcomes (1)

  • Change in oral opioid dose.

Interventions

ketorolacDRUG
morphineDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Implanted spinal pump for at last 9 months
  • Must be receiving and the dose must have been doubled in the past 6 months
  • Currently taking 60-200 mg morphine equivalent as oral rescue per day
  • Men and women, ages 18-70
  • Weigh no more that 250 pounds
  • Neuropathic pain

You may not qualify if:

  • Pregnancy
  • Unstable medical problems (heart lung, liver, kidney, or nervous system)
  • Allergy to morphine, ketorolac, or drugs which may be used to treat side effects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainChronic Pain

Interventions

KetorolacMorphine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • James C. Eisenach, M.D.

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

  • Richard Rauck, M.D.

    The Center for Clinical Research

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2006

First Posted

July 7, 2006

Study Start

December 1, 2006

Last Updated

November 6, 2017

Record last verified: 2009-05