NCT00007254

Brief Summary

This study tests the effectiveness of a morphine-containing gel for reducing pain caused by pressure ulcers, also known as bedsores or pressure sores. We will apply the gel containing morphine, or the gel alone, directly onto painful pressure ulcers and compare the results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2000

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

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

March 1, 2000

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2000

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2000

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
Last Updated

May 20, 2013

Status Verified

May 1, 2013

First QC Date

December 16, 2000

Last Update Submit

May 17, 2013

Conditions

Decubitus Ulcer

Keywords

AnalgesiaBedsoreMorphine gelPressure ulcerPainUlcer

Interventions

Pain relief for pressure ulcersDRUG

Eligibility Criteria

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

You may qualify if:

  • Presence of a Stage II pressure ulcer.
  • Pressure ulcer must be painful.
  • Primary Care physician must approve participation.
  • Thinking ability must be clear and intact.
  • Willing to change pain medication to oxycodone.

You may not qualify if:

  • Allergy to morphine, oxycodone or intrasite gel.
  • Use of codeine- or morphine-containing medications.
  • Use of pain medications for anything other than the pressure ulcer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Kindred Hospital

Kansas City, Missouri, United States

Location

Related Publications (1)

  • Twillman RK, Long TD, Cathers TA, Mueller DW. Treatment of painful skin ulcers with topical opioids. J Pain Symptom Manage. 1999 Apr;17(4):288-92. doi: 10.1016/s0885-3924(98)00140-7.

    PMID: 10203881BACKGROUND

MeSH Terms

Conditions

Pressure UlcerAgnosiaPainUlcer

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • Teresa D. Long, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 16, 2000

First Posted

December 18, 2000

Study Start

March 1, 2000

Study Completion

February 1, 2003

Last Updated

May 20, 2013

Record last verified: 2013-05

Locations

US(2)