CClinicalTrials.gg
WithdrawnNCT00306020Updated Jul 4, 2012

Analgesia and Wound Healing Assessment Following Topical Morphine Applied to Patients With Cutaneous Cancer Related Pain

An interventional study of topical morphine in Ulcer and Wounds and Injuries, sponsored by Soroka University Medical Center. Withdrawn. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-07-04.

Sponsored by Soroka University Medical Center · Not applicable, Interventional, and Treatment

Why this study was withdrawn
The study was withdrawn due to difficulties in recruiting appropriate patients in community clinic setting
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Cutaneous cancer-related pain is difficult to treat. These patients are often prescribed high systemic dosages of opioids. Yet, many patients continue to report pain while experiencing dose-limiting side effects. An alternative approach to systemic administration is to apply topical medications. The advantage of topical application is the potential of achieving good analgesia using low dosages with few, if any, systemic side effects. Current clinical data indicates, that topically applied morphine has an analgesic effect in patients with severe pain and that it may even improve wound healing. The clinical reports so far have been either case studies or double blind randomly controlled trials with a very small sample size of patients. There is still a great deal of information which is lacking about this modality of treatment regarding on the one hand, the mechanism of action and on the other, clinical issues. For example, is the mechanism of the effect actually peripheral? What is the adequate dose of analgesic medication for different types of skin conditions? Wound healing has not been quantified.

We will apply morphine topically to skin wounds of cancer and evaluate the effect of the treatment on pain, side effects, quantify wound healing, quantify morphine and its metabolites in blood and urine.

Should well controlled studies, demonstrate all or any of the peripheral effects of topical morphine, clinical application of this treatment modality would be possible. This could contribute towards better treatment of these patients, who have pain which is difficult to treat and can, at times, be intractable.

02

Conditions studied

  • Ulcer
  • Wounds and Injuries

Keywords

  • Skin ulcers
  • Topical morphine
  • Chronic pain
  • Cancer
03

In context

Cancer Pain

338 studies on the registry are indexed under Cancer Pain; 71 are open to participants now.

Browse Cancer Pain studies →

Lead sponsor

Soroka University Medical Center is the lead sponsor of 157 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Moderate to severe resting pain (scores above 5/10).
  • Stable analgesic regimen.
  • No surgical interventions planned during the study period.
  • Able to self-assess pain and report it.
  • Hospitalized or receiving home care for Stage I; out-patients or receiving home care for Stage II.
  • Wound not infected or covered with necrotic tissue.

Exclusion criteria

Exclusion Criteria:

  • True sensitivity to opioids
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
0 participants (actual)

Interventions

  • Drugtopical morphine
06

What researchers measure

Primary outcomes

  1. pain intensity reports

  2. frequency and type of side effects

  3. blood and urine levels of morphine and its metabolites, morphine 3- and 6-glucuronide

Secondary outcomes

  1. quantification of wound healing

  2. change in use of regular analgesics

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00306020
Lead sponsor
Soroka University Medical Center
Collaborators
Israel Cancer Association
Responsible party
Pesach Shvartzman (Head-Department of Family Medicine, Soroka University Medical Center) — Principal investigator
First posted
Mar 22, 2006
Start date
Jan 2006
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Jul 4, 2012

Study contacts

Pesach Shvartzman, Professor
principal investigator · Ben-Gurion University of the Negev, Sial Research Center for Family Medicine and Primary Care
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion