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NCT04330547
Use of Analgesic Treatment to Reduce Signs of Pain in Patients With Disorders of Consciousness.
Phase 1 trial testing Analgesic administration in Disorders of Consciousness in 19 participants. Completed in 28 April 2021.
19 February 2019
Quick facts
| Lead sponsor | University of Liege |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | supportive care |
| Enrollment | 19 |
| Start date | 21 February 2018 |
| Primary completion | 19 February 2019 |
| Estimated completion | 28 April 2021 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Analgesic administration — full drug profile →
- Placebo administration — full drug profile →
Conditions studied
- Disorders of Consciousness — all drugs for Disorders of Consciousness →
- Severe Brain Injury — all drugs for Severe Brain Injury →
- Post-comatose Non-communicative Patients — all drugs for Post-comatose Non-communicative Patients →
- Vegetative State — all drugs for Vegetative State →
Sponsor
University of Liege
Who can join
Adults 16 to 99, any sex, with Disorders of Consciousness or Severe Brain Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to characterize and improve pain and nociception management in patients with disorders of consciousness (DOC). This project is divided into two phases, a first phase to evaluate pain level and a second phase which consist of a clinical trial to evalute pain medication efficacy. The main aim is to evaluate the use of the Nociception Coma Scale-Revised (NCS-R) and its cut-off score (i.e., 5) as an assessment and management tool to define guidelines for managing pain in patients with DOC. In this double-blind, placebo-controlled clinical study, we will evaluate the use of analgesic treatments in reducing pain in subacute/chronic patients. The project will also allow us to validate the NCS-R cut-off score defined previously.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04330547
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Disorders of Consciousness
Currently open trials in the same condition.
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- NCT06851156 — Transcranial Temporal Interference Stimulation In Severely Brain Injured Patients With Disorders of Consciousness · NA · recruiting
- NCT06464549 — Spontaneous Eye Blinking Evaluation for Cognitive Assessment of Individuals With Severe Acquired Brain Injury · active not recruiting
- NCT07284732 — Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Patients With Disorders of Consciousness · NA · recruiting
Other University of Liege trials
Trials by the same sponsor.
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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 NCT04330547 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Liege
- Last refreshed: 3 May 2021
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/NCT04330547.
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