Last reviewed · How we verify
NCT00229424
Verification Study on Lafutidine in Mild Reflux Oesophagitis - Double Blind Controlled Study With Famotidine -
Phase 3 trial testing Lafutidine in Gastroesophageal Reflux in 325 participants. Completed in 1 January 2007.
1 October 2006
Quick facts
| Lead sponsor | Taiho Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 325 |
| Start date | 1 April 2005 |
| Primary completion | 1 October 2006 |
| Estimated completion | 1 January 2007 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- Lafutidine (LAFUTIDINE) — full drug profile →
- Famotidine (famotidine) — full drug profile →
- Placebo
Conditions studied
- Gastroesophageal Reflux — all drugs for Gastroesophageal Reflux →
Sponsor
Taiho Pharmaceutical Co., Ltd. — full company profile →
Who can join
20 and older, any sex, with Gastroesophageal Reflux. 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.
-
Endoscopic healing rate
Time frame: At the eighth week after treatment
Sponsor's own description
The purpose of the study is to verify superiority of the lafutidine group over the placebo group and non-inferiority to the famotidine group in terms of endoscopic healing rate of the patients with mild reflux oesophagitis. Furthermore, the followings are compared: The improvement effect in heartburn and other subjective symptoms, and dosing frequency of MALFA ® suspension (neutralizer) as well as incidence of adverse events among the lafutidine 20 mg/day treatment group, the famotidine 40 mg/day treatment group and the placebo treatment group in patients with mild reflux oesophagitis.
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 NCT00229424
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Lafutidine
Trials testing the same drug.
- NCT02759224 — A Study to Compare the Pharmacokinetics of Lafutidine and Irsogladine Maleate Tablet · Phase 1 · completed
Other recruiting trials for Gastroesophageal Reflux
Currently open trials in the same condition.
- NCT07291700 — Study on Hydrotalcite for Relief of Acid Symptoms Due to Acid Rebound After Stopping Long-Term PPI Therapy · recruiting
- NCT06255886 — Treatment of Gastroesophageal Reflux Disease in Infants · Phase 4 · recruiting
- NCT06534359 — Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia · NA · recruiting
- NCT06687603 — Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms · NA · recruiting
- NCT06339801 — Role of Mucosal Impedance Measurement for the Diagnosis of Gastroesophageal Reflux Disease · recruiting
Other Taiho Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT05691660 — A Study of TAS3731 in Healthy Adults · Phase 1 · completed
- NCT05621447 — A Mass Balance Study of [14C] TAS-303 in Healthy Adult Male Subjects · Phase 1 · completed
- NCT05335499 — A Phase 2a Study of TAS5315 in Patients With Chronic Spontaneous Urticaria · Phase 2 · completed
- NCT04825431 — Mass Balance Study of [14C] TAS-205 in Healthy Volunteers · Phase 1 · completed
- NCT04512053 — A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence · Phase 2 · completed
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 NCT00229424 (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 Taiho Pharmaceutical Co., Ltd.
- Last refreshed: 6 July 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/NCT00229424.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing