A Phase 4 interventional study of fentanyl in Pain, sponsored by Janssen Cilag S.A.S.. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-17.
Sponsored by Janssen Cilag S.A.S. (part of Johnson & Johnson) · Phase 4, Interventional, and Treatment
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Among 10 studies testing fentanyl in Cancer Pain — 1 open to participants now, 1 under way, none of them phase 3. Fentanyl · Cancer Pain.
Among the 10 studies testing fentanyl in Cancer Pain, this one is the 10th largest by enrollment, is the only one that started in 2003, is one of 5 in phase 4, and was the 2nd registered.
310 studies on the registry are indexed under Cancer Pain; 73 are open to participants now.
Browse Cancer Pain studies →1 of the 10 studies testing fentanyl in Cancer Pain is open now, in 1 country. Recruiting first, the newest first:
Erasmus Medical Center · Sites in Netherlands
Ages 18–120
By country, each count listing its studies:
Fentanyl: first FDA approval 1968 (SUBLIMAZE PRESERVATIVE FREE), first EMA approval 2006. What it is approved for, and how studies give it, is on its page →
Of the 43 Cancer Pain studies recruiting now, 31 (72%) set no upper age limit and 4 (9%) stop at 75 or younger; 4 take children under 18; none take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2003.
This study's enrollment of 34 is below the median of 62 across 235 interventional studies indexed under Cancer Pain.
Median enrollment 62 across the 10 interventional studies. Of the 8 that completed or were terminated, 2 (25%) have results posted.
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7 of 10 have an industry lead sponsor. The 8 most frequent:
This study is registered under Janssen Cilag S.A.S., one of the names counted as Johnson & Johnson. Under that name alone:
Janssen Cilag S.A.S. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
17 studies in Cancer Pain by Johnson & Johnson: none open now, none under way, none of them phase 3. Of 17 finished, 4 (24%) have results posted.
Among the 17 studies in Cancer Pain by Johnson & Johnson, this one is the 10th largest by enrollment of the 13 interventional ones that give a count, is one of 2 that started in 2003, is one of 7 in phase 4, and was the 2nd registered.
Johnson & Johnson’s Cancer Pain studies by the year they started, since 2003.
None of the studies under way reaches primary completion within a year.
Among the 10 studies testing fentanyl in Cancer Pain, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Johnson & Johnson’s 17 in Cancer Pain:
Nothing recorded among them since 2026-09-25.
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The purpose of this study is to determine the safety and efficacy of pain control by fentanyl, administered via adhesive skin patches, at doses of 25 to 100 micrograms per hour in 80 out-patients with intense chronic cancer pain. Higher doses are allowed by permission of the investigator and rescue oral morphine medication is allowed.
Patients with cancer pain are frequently under-medicated with morphine. This is a 56-day open-label study of the efficacy and safety of self-administered fentanyl skin patches for cancer pain control in patients in the home-care setting not previously using morphine. The first 15 days of the study are for dose stabilization and the rest of the study assesses pain control and quality of life at stable doses of medication. The dose is determined by the patient with oversight by the investigator, and rescue oral morphine medication can be used when necessary. The patient records all medication use in a diary and fills out questionnaires concerning pain control, intestinal function (constipation) and overall quality of life. The hypothesis is that patients will be able to control their cancer pain by self-administering transdermal fentanyl at home and that they will well tolerate the medication.
Individualized doses, with a target dose of 25 to 100 micrograms per hour of fentanyl for 56 days via skin patches applied every 3 days to deliver 25 to 100 micrograms of fentanyl per hour per patch; oral morphine as rescue medication for pain.
310 studies on the registry are indexed under Cancer Pain; 73 are open to participants now.
This study's enrollment of 34 is below the median of 62 across 235 interventional studies indexed under Cancer Pain.
Browse Cancer Pain studies →Janssen Cilag S.A.S. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Compared within Cancer Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pain. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Pain control level using a visual analog scale (VAS) at various time points and at the end of 56-day study. Percent pain reduction and percentage of patients having a score of 4 or lower compared to the baseline. Use of rescue medication.
Constipation and recorded use of laxatives, patient-assessed quality of life obtained by questionnaires and overall tolerance assessed at the end of 56-day study.
No study locations are listed for this record.
The record gives a start of Jun 2003 and a completion of May 2004. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fentanyl