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Pain, BreakthroughPhase 1/2NCT05037539

Efficacy of Injectable Fentanyl in Sublingual Route Versus Oral Morphine Syrup for Breakthrough Pain

A Phase 1/2 study testing Fentanyl Citrate 50Mcg/Ml Inj_#1 and Morphine in people with Pain, Breakthrough, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.

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

Randomized control trial that to comparison the efficacy of injectable fentanyl in sublingual route versus oral morphine syrup for breakthrough pain in gynecologic cancer patients with chronic cancer pain Primary outcome : to measure pain score after drug is given Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Pain, Breakthrough
What is being tested?
Fentanyl Citrate 50Mcg/Ml Inj_#1 and Morphine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteThailand
Study dates
15 Jun 2021to 30 Jun 2022
Phase
Phase 1/2
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Gynecologic cancer patients with chronic cancer pain that use opioid drug for basal pain

Who cannot join

  • allergy in fentanyl or morphine
  • abnormal cognitive function patient

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Rajavithi Hospital

    Bangkok

Other trials in Thailand

About this study

Official title: Efficacy of Injectable Fentanyl in Sublingual Route Versus Oral Morphine Syrup for Breakthrough Pain in Gynecologic Cancer Patients With Chronic Cancer Pain : A Randomized Double Blind Controlled Trial

Randomized control trial that to comparison the efficacy of injectable fentanyl in sublingual route versus oral morphine syrup for breakthrough pain in gynecologic cancer patients with chronic cancer pain Primary outcome : to measure pain score after drug is given

Read the detailed description

objective; To comparison the efficacy of injectable fentanyl in sublingual route versus oral morphine syrup for breakthrough pain in gynecologic cancer patients with chronic cancer pain Population : gynecologic cancer patients with chronic cancer pain that use opioid drug for basal pain and had experienced of breakthrough pain cancer in Rajavithi hospital sample size : 20 person/group Method ; Randomized control trial , Prospective Intervention : group A : injectable fentanyl in sublingual , group B : oral morphine syrup Primary outcome : to measure pain score after drug is given at 5, 15, 30, 45, 60 and 120 min secondary outcome : to record side effect of drug is given at 5, 15, 30, 45, 60 and 120 min Statistical method

  • Categorical data = Chi-square test or Fishers' exact test
  • Continuous data : comparison with Student t-test in normal deviation data and Man-Whitney U- test in abnormal deviation data • Analytical data with Pearson's correlation, Linear regression or Binary Logistic regression, Repeated Measures ANOVA with OR (95%CI) and p-value <0.05
Being tested
Fentanyl Citrate 50Mcg/Ml Inj_#1, Morphine
Keywords
breakthrough pain, Injectable Fentanyl in Sublingual Route, gynecologic cancer
Medical subject headings
Breakthrough Pain

What participants receive

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

  • Fentanyl Citrate 50Mcg/Ml Inj_#1Drug

    Also called Fentanyl

    Injectable Fentanyl in Sublingual Route 50 mcg

  • MorphineDrug

    Also called morphine syrup

    Oral Morphine Syrup 2.5 ml ( 5 mg)

Study groups in NCT05037539
Study groupRoleWhat they receive
Injectable Fentanyl in Sublingual RouteExperimentalInjectable Fentanyl in Sublingual Route that given after the first time Breakthrough Pain is occurred 50 mcg in sublingual route
Receives: Drug: Fentanyl Citrate 50Mcg/Ml Inj_#1
Oral Morphine SyrupActive comparatorOral Morphine Syrup 2.5 ml ( 5 mg) in oral router that first time given after Breakthrough Pain is occurred
Receives: Drug: Morphine

What is being measured

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

  1. Pain score

    measure with numeric score from 0-10 point (maximum pain= 10 point)

    Measured: after drug is given at 5 minutes

Secondary outcomes (3)

  1. Neausea and vomiting

    measure by asking symptom from patient

    Measured: after drug is given at 5 minutes

  2. Ithching

    measure by asking symptom from patient

    Measured: after drug is given at 5 minutes

  3. Respiratory distress

    measure by respiratory rate parametor

    Measured: after drug is given at 5 minutes

Timeline

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

  1. First posted8 Sep 2021
  2. Study start15 Jun 2021
  3. Primary completion30 Dec 2021
  4. Study completion30 Jun 2022

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 1/2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05037539
Sponsor's protocol ID
090/2564
Status last verified
Aug 2021
First submitted
24 May 2021
Last updated
31 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lennernas B, Hedner T, Holmberg M, Bredenberg S, Nystrom C, Lennernas H. Pharmacokinetics and tolerability of different doses of fentanyl following sublingual administration of a rapidly dissolving tablet to cancer patients: a new approach to treatment of incident pain. Br J Clin Pharmacol. 2005 Feb;59(2):249-53. doi: 10.1111/j.1365-2125.2004.02264.x.

    PubMed 15676050

  • Portenoy RK, Payne D, Jacobsen P. Breakthrough pain: characteristics and impact in patients with cancer pain. Pain. 1999 May;81(1-2):129-34. doi: 10.1016/s0304-3959(99)00006-8.

    PubMed 10353500

  • Zeppetella G. Opioids for cancer breakthrough pain: a pilot study reporting patient assessment of time to meaningful pain relief. J Pain Symptom Manage. 2008 May;35(5):563-7. doi: 10.1016/j.jpainsymman.2007.06.012. Epub 2008 Feb 6.

    PubMed 18258412

  • Mercadante S. The use of rapid onset opioids for breakthrough cancer pain: the challenge of its dosing. Crit Rev Oncol Hematol. 2011 Dec;80(3):460-5. doi: 10.1016/j.critrevonc.2010.12.002. Epub 2011 Jan 6.

    PubMed 21215653

  • Jandhyala R, Fullarton JR, Bennett MI. Efficacy of rapid-onset oral fentanyl formulations vs. oral morphine for cancer-related breakthrough pain: a meta-analysis of comparative trials. J Pain Symptom Manage. 2013 Oct;46(4):573-80. doi: 10.1016/j.jpainsymman.2012.09.009. Epub 2013 Feb 4.

    PubMed 23380337

  • Velazquez Rivera I, Munoz Garrido JC, Garcia Velasco P, Espana Ximenez de Enciso I, Velazquez Clavarana L. Efficacy of sublingual fentanyl vs. oral morphine for cancer-related breakthrough pain. Adv Ther. 2014 Jan;31(1):107-17. doi: 10.1007/s12325-013-0086-4. Epub 2014 Jan 3.

    PubMed 24385406

  • Bushnaq M, Al-Shoubaki M, Milhem M. The feasibility of using intravenous fentanyl as sublingual drops in the treatment of incidental pain in patients with cancer. J Palliat Med. 2009 Jun;12(6):511-4. doi: 10.1089/jpm.2009.9618. No abstract available.

    PubMed 19508134

  • Thantiprechapong T, Tilagul T, Vasikasin V. Efficacy of reconstituted intravenous fentanyl to sublingual solution versus oral morphine syrup for breakthrough pain among patients with chronic gynecologic cancer pain: A randomized, double-blind, placebo-controlled trial. J Obstet Gynaecol Res. 2023 Jul;49(7):1815-1820. doi: 10.1111/jog.15674. Epub 2023 May 11.

    PubMed 37170709

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Fentanyl Citrate 50Mcg/Ml Inj_#1 and Morphine in people with Pain, Breakthrough, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.

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 1 inclusion and 2 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 31 Aug 2022. 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 Thailand. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Pain score (time frame: after drug is given at 5 minutes). 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 NCT05037539, which also lists 8 linked publications.

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 31 Aug 2022.

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