Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229424
Status:
COMPLETED
Last Update Posted:
2011-07-07
First Post:
2005-09-28
Brief Title:
Verification Study on Lafutidine in Mild Reflux Oesophagitis - Double Blind Controlled Study With Famotidine -
Sponsor:
Taiho Pharmaceutical Co Ltd
Organization:
Taiho Pharmaceutical Co Ltd
Study Overview
Official Title:
Verification Study on Lafutidine in Mild Reflux Oesophagitis - Double Blind Controlled Study With Famotidine -
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 mgday treatment group the famotidine 40 mgday treatment group and the placebo treatment group in 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 mgday treatment group the famotidine 40 mgday treatment group and the placebo treatment group in patients with mild reflux oesophagitis
Detailed Description:
In Japan it is reported that many patients with reflux oesophagitis are relatively mild and do not usually require strong treatment and even H2 receptor antagonists are considered to demonstrate sufficient healing effects Haruma thinks that the first choice should be PPI in principle which has the best therapeutic effect as the medical guideline if a patient has a strong reflux symptom such as heartburn or is diagnosed with severe reflux oesophagitis Grade C or D according to the Los Angels Classification as a result of the upper gastrointestinal endoscopic test Later after healing is confirmed at 8 weeks of treatment or after the subjective symptoms have been improved the dose of PPI should be reduced to half to transfer to maintenance therapy On the other hand if a patient has mild subjective symptoms or develops mild reflux oesophagitis Grade A or B according to the Los Angels Classification as a result of the upper gastrointestinal endoscopic test only about 10 of such patients aggravate in the long-run and some patients heal in the natural course Therefore considering that Japanese gastric-acid secretion is lower than Westerners they recommend that antacids such as H2 receptor antagonists or sodium alginates is used to treat symptoms as they appear along with the improvement in the lifestyle As mentioned above lafutidine that strongly suppresses acid secretion during the daytime from the initial phase of treatment is expected to demonstrate sufficient effect in treatment of mild reflux oesophagitis similar to the conventional H2 receptor antagonists
Based on above the clinical trial is planned with the objective to confirmedly demonstrate the efficacy of lafutidine in mild reflux oesophagitis
Comparisons The endoscopic healing rate of lafutidine in the patients with mild reflux oesophagitis is compared to the rate of placebo and it is also compared to the rate of famotidine
Based on above the clinical trial is planned with the objective to confirmedly demonstrate the efficacy of lafutidine in mild reflux oesophagitis
Comparisons The endoscopic healing rate of lafutidine in the patients with mild reflux oesophagitis is compared to the rate of placebo and it is also compared to the rate of famotidine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LAFGER3D1FN01 | None | None | None |