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NCT01195233: BioXtra
Comparison Study of BioXtra Spray and Mouth Rinse in Patient With Radiation-induced Xerostomia
Phase 2 trial testing bioxtra in Radiation-Induced Xerostomia in 20 participants. Completed in 1 September 2010.
1 August 2010
Quick facts
| Lead sponsor | Qazvin University Of Medical Sciences |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 20 |
| Start date | 1 July 2010 |
| Primary completion | 1 August 2010 |
| Estimated completion | 1 September 2010 |
| Sites | 1 location across Iran |
Drugs / interventions tested
- bioxtra — full drug profile →
Conditions studied
- Radiation-Induced Xerostomia — all drugs for Radiation-Induced Xerostomia →
Sponsor
Qazvin University Of Medical Sciences
Who can join
18 and older, any sex, with Radiation-Induced Xerostomia. 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.
-
improvement of xerostomia
Time frame: 2 weeks
change of symptoms of xerostomia is measured by Visual Analogue Scale and Dichotomos questionnaire\[ Time Frame: baseline compared with measures on day 14
Sponsor's own description
The present study compared the efficacy of BioXtra spray and mouth rinse in the relief of radiotherapy-induced xerostomia in patients referred to Cancer Institute, Tehran Imam Khomeini Hospital.
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 NCT01195233
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT01195233 (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 Qazvin University Of Medical Sciences
- Last refreshed: 18 April 2011
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/NCT01195233.
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