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NCT01426295: Caphosol
Pharmaco-economic Cost-effective Prospective Randomized Trial Evaluating the Open Interest Caphosol ® Mouthwashes in the Prevention and Treatment of Severe Oral Mucositis in Patients Receiving High-dose Chemotherapy in Hematology
Phase 2 trial testing Caphosol in Hematologic Disease in 92 participants. Completed in 1 April 2014.
1 April 2013
Quick facts
| Lead sponsor | Nantes University Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Enrollment | 92 |
| Start date | 1 April 2011 |
| Primary completion | 1 April 2013 |
| Estimated completion | 1 April 2014 |
| Sites | 1 location across France |
Drugs / interventions tested
- Caphosol — full drug profile →
- Bicarbonate de sodium — full drug profile →
Conditions studied
- Hematologic Disease — all drugs for Hematologic Disease →
Sponsor
Nantes University Hospital
Who can join
18 and older, any sex, with Hematologic Disease. 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.
-
assess the cost-effectiveness ratio is the number of days with severe mucositis won.
Time frame: up to 28 days
Sponsor's own description
The purpose of the study is to determine whether the use of mouthwashes Caphosol ™ in addition to standard oral care (strategy A) is cost-effective in the prevention and treatment of severe mucositis in adult patients with auto or allograft packaging without ICT versus mouthwashes standard bicarbonates with an antiseptic (strategy B).
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 NCT01426295
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Caphosol
Trials testing the same drug.
- NCT02807337 — Supersaturated Calcium Phosphate Oral Rinse (Caphosol®) For the Prevention of Oral Mucositis in Children Undergoing Chem · Phase 2 · completed
- NCT02589145 — Lenalidomide Combined With Vorinostat/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Diffus · Phase 1, PHASE2 · terminated
- NCT01809756 — The Effect of Caphosol® on the Development of Esophagitis in (N)SCLC Patients Treated With Concurrent Chemo/Radiotherapy · NA · terminated
- NCT01983969 — Aza-SAHA-GBM With AutoSCT for Refractory Lymphoma · Phase 1, PHASE2 · completed
Other recruiting trials for Hematologic Disease
Currently open trials in the same condition.
- NCT06849921 — Precise Design of Cell Therapy for Relapsed and Refractory Hematological Tumors · NA · active not recruiting
- NCT06809712 — Human Leukocyte Antigen (HLA) Mismatched Unrelated Allogeneic Hematopoietic Stem Cell Transplantation · Phase 1 · recruiting
Other Nantes University Hospital trials
Trials by the same sponsor.
- NCT07278661 — Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery. · Phase 2 · recruiting
- NCT06681363 — Creation of a Biocollection of Patients With Acute Myeloid Leukemia (AML) or Lymphoid Leukemia (ALL) or High-risk Myelod · not yet recruiting
- NCT07467382 — GOAT (Gait Observation of Achilles Tendon) · not yet recruiting
- NCT07490379 — Comparison of the Efficacy of Transcranial Direct Current Stimulation at Home Versus in Hospital Settings in Patients Wi · NA · not yet recruiting
- NCT07423481 — Weight Trajectories and Predictive Factors After Semaglutide in Patients With Grade 3 and Complicated Obesity · not yet recruiting
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 NCT01426295 (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 Nantes University Hospital
- Last refreshed: 2 May 2016
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/NCT01426295.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing