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GastrostomyPhase 4ANTALGIPNCT02869321

Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy

A Phase 4 study testing Fentanyl, Morphine Sulfate and Gastrostomy in people with Gastrostomy and Breakthrough Pain, run by Central Hospital, Nancy, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients with Head \& Neck Squamous Cell Carcinoma often need a gastrostomy. It can be performed with a radiological approach. This procedure is usually not performed under general anesthesia, but local anesthesia is not sufficient to counteract pain due to gastric insufflation and incision of the abdominal wall. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fentanyl, Morphine Sulfate and Gastrostomy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteFrance
Study dates
May 2015to May 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient care for cancer of the upper aerodigestive tract (except sinonasal)
  • > 18, all weights, all sexes
  • Under balanced background opioid treatment since longer than 7 days (VAS < 5)
  • Needing a radiologic gastrostomy under local anesthesia
  • Informed consent
  • Affiliation to social security plan
  • Preliminary medical examination

Who cannot join

  • Non balanced morphinic treatment : modification of analgesic treatment during 7 previous days
  • Radiotherapy of nasal fossae/sinus
  • Technical impossibility or contraindication to PECFENT®, ORAMORPH® and associated drugs
  • Impossibility of pain evaluation by patient
  • Belonging to protected class: pregnant or breastfeeding woman, person deprived of liberty for judiciary or administrative decision, under-18, person under legal protection or incapable of giving consent, person in life-and-death emergency incapable of giving a preliminary consent

Trial locations and contacts

1 site in 1 country.

France1 site

  • Service ORL - CHU NANCY

    Nancy

Other trials in France

About this study

Official title: Evaluation of Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy

Patients with Head \& Neck Squamous Cell Carcinoma often need a gastrostomy. It can be performed with a radiological approach. This procedure is usually not performed under general anesthesia, but local anesthesia is not sufficient to counteract pain due to gastric insufflation and incision of the abdominal wall. Standard analgesic treatments are usually not well-fitted due to onset of action or route of administration. An alternative solution could be fentanyl nasal spray, a treatment with a fast onset of action and with easy use allowing repetition if needed, during the procedure.

The purpose of this study is to compare analgesic efficacy of nasal instillation of PECFENT® to usually administered morphinic analgesic treatment with fast onset of action (ORAMORPH®), in radiologic percutaneous gastrostomy tube placement:

Read more
  • during the procedure
  • following the procedure (measured by Visual Analog Scale (VAS) for Pain at 15 min, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 12 hours after procedure).

Secondary purposes are to compare easiness of 2 treatments and their adverse effects.

Being tested
Fentanyl, Morphine Sulfate, Fentanyl placebo, Morphine Sulfate placebo, Gastrostomy
Medical subject headings
Breakthrough Pain, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FentanylDrug

    Also called PECFENT®

  • Morphine SulfateDrug

    Also called ORAMORPH®

  • Fentanyl placeboDrug

  • Morphine Sulfate placeboDrug

  • GastrostomyProcedure or surgery

Study groups in NCT02869321
Study groupRoleWhat they receive
FentanylExperimentalAdministration of Morphine Sulfate Placebo and Fentanyl 1. Morphine Sulfate Placebo: oral solution administered through nasogastric tube, 10% of daily dose of morphine of background treatment, 1 hour before gastrostomy + 2. Fentanyl: nasal spray solution, 100 µg pulverisation, 15 min before gastrostomy, if not efficacy second dose after 15 min during gastrostomy Administration 1+2 if pain after 4 hours from gastrostomy
Receives: Drug: Fentanyl; Drug: Morphine Sulfate placebo; Procedure: Gastrostomy
Morphine SulfatePlacebo comparatorAdministration of Morphine Sulfate and Fentanyl Placebo 1. Morphine Sulfate: oral solution administered through nasogastric tube, 10% of daily dose of morphine of background treatment, 1 hour before gastrostomy + 2. Fentanyl Placebo: nasal spray solution, 100 µg pulverisation, 15 min before gastrostomy, if not efficacy second dose after 15 min during gastrostomy Administration 1+2 if pain after 4 hours from gastrostomy
Receives: Drug: Morphine Sulfate; Drug: Fentanyl placebo; Procedure: Gastrostomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intensity of breakthrough pain during the gastrostomy

    Pain measured by VAS

    Measured: during gastrostomy

  2. Intensity of pain following the gastrostomy

    Pain measured by VAS

    Measured: 15 min after gastrostomy

  3. Intensity of pain following the gastrostomy

    Pain measured by VAS

    Measured: 30 min after gastrostomy

  4. Intensity of pain following the gastrostomy

    Pain measured by VAS

    Measured: 1 hour after gastrostomy

  5. Intensity of pain following the gastrostomy

    Pain measured by VAS

    Measured: 2 hours after gastrostomy

  6. Intensity of pain following the gastrostomy

    Pain measured by VAS

    Measured: 3 hours after gastrostomy

  7. Intensity of pain following the gastrostomy

    Pain measured by VAS

    Measured: 4 hours after gastrostomy

  8. Intensity of pain following the gastrostomy

    Pain measured by VAS

    Measured: 6 hours after gastrostomy

  9. Intensity of pain following the gastrostomy

    Pain measured by VAS

    Measured: 12 hours after gastrostomy

  10. Necessity of a second analgesic treatment after gastrostomy

    in case of Pain VAS >4

    Measured: up to 12 hours from gastrostomy

Secondary outcomes (4)

  1. Evaluation of satisfaction of patient with analgesic efficacy

    Questionnaire

    Measured: up to 1 day from gastrostomy

  2. Evaluation of satisfaction of staff with analgesic efficacy and easiness to use of treatments

    Questionnaire

    Measured: up to 1 day from gastrostomy

  3. Compliance of times of administration of treatments with the procedure

    Measured: day 0

  4. Comparison of adverse effects of administered drugs

    Measured: up to 24 hours post gastrostomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2016 (estimated)
  2. Study startMay 2015
  3. Primary completionMay 2018
  4. Study completionMay 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02869321
Sponsor's protocol ID
2014-003352-32
Other IDs
2014
Acronym
ANTALGIP
Status last verified
May 2018
First submitted
8 Aug 2016
Last updated
13 May 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fentanyl, Morphine Sulfate and Gastrostomy in people with Gastrostomy and Breakthrough Pain, run by Central Hospital, Nancy, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intensity of breakthrough pain during the gastrostomy (time frame: during gastrostomy). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02869321.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.

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