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NCT00357942
Local Administration of Morphine: An Evaluation of the Analgesic Effect at Stomatitis in Children
Phase 4 trial testing morphine solution for injection in Pain in 72 participants. Completed in 1 January 2014.
1 December 2013
Quick facts
| Lead sponsor | Danish University of Pharmaceutical Sciences |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 72 |
| Start date | 1 September 2006 |
| Primary completion | 1 December 2013 |
| Estimated completion | 1 January 2014 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- morphine solution for injection — full drug profile →
- Placebo
- morphine mouthwash — full drug profile →
- Placebo
Conditions studied
Sponsor
Danish University of Pharmaceutical Sciences
Who can join
Eligibility, any sex, with Pain or Mucositis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Use of supplemental analgesics
Time frame: 24 hours
Sponsor's own description
Stomatitis/oral mucositis is a common side effect to chemotherapy. Stomatitis is often associated with painful ulcers in the mouth. The study hypothesis is that morphine administrated as a mouthwash can relieve stomatitis-related pain by a local analgesic effect. The purpose of this study is to test the analgesic effect of a morphine mouthwash versus morphine injections or placebo (no active drug) in children/adolescents with stomatitis related to chemotherapy. Besides the investigational drugs (morphine mouthwash and morphine injections) the children/adolescents receive a standardized analgesic treatment for stomatitis-related pain.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Evaluation of topical morphine for treatment of oral mucositis in cancer patients.
Nielsen BN, Friis SM, Schmiegelow K, Henneberg S, et al · · 2021 · cited 3× · PMID 34840789 · DOI 10.1177/2049463720975061
Verify or expand the search:
- PubMed search for NCT00357942
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00357942 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Danish University of Pharmaceutical Sciences
- Last refreshed: 20 February 2014
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00357942.
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