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NCT02457429
A Validation Study of the Dx-pH Probe in Children for the Detection of Extra-oesophageal Reflux
NA trial testing Experiemental diagnostic procedure: Dx-pH measurement system in Gastro-oesophageal Reflux in 16 participants. Completed in 28 April 2017.
28 April 2017
Quick facts
| Lead sponsor | Manchester University NHS Foundation Trust |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 16 |
| Start date | 22 March 2013 |
| Primary completion | 28 April 2017 |
| Estimated completion | 28 April 2017 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Experiemental diagnostic procedure: Dx-pH measurement system
- Peptest assay
- GORD symptom questionnaire
Conditions studied
- Gastro-oesophageal Reflux — all drugs for Gastro-oesophageal Reflux →
Sponsor
Manchester University NHS Foundation Trust
Who can join
Adults 1 to 16, any sex, with Gastro-oesophageal Reflux. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Gastro-oesophageal reflux (GORD) and its extraoesophageal manifestations present with a variety of symptoms in both adult and paediatric populations. In children the effects of refluxate above the upper oesophageal sphincter (UES) has been implicated as a contributory factor in the underlying pathological processes of a number of conditions including apnoea, asthma, chronic cough, subglottic stenosis, chronic rhinosinusitis and otitis media. The absence of typical symptoms in addition to the inability to obtain a formal symptom history from a young paediatric population contributes to the difficulty in establishing a diagnosis. At present there are no studies or data directly measuring extraoesophageal reflux and its correlation to oesophageal pH monitoring in children. The use of twenty-four hour oesophageal pH monitoring is regarded as the established technique for diagnosis of GORD, however this technique has been less reliable for detecting extra-oesophageal reflux. The investigators intend to use the Dx-pH Measurement system, a sensitive and minimally invasive transnasal device, to assess the feasibility and validate its use in a paediatric population.
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 NCT02457429
- Europe PMC full search
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Related trials
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Currently open trials in the same condition.
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Other Manchester University NHS Foundation Trust trials
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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 NCT02457429 (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 Manchester University NHS Foundation Trust
- Last refreshed: 18 January 2019
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/NCT02457429.
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