A Phase2 Clinical Trial of Trafermin in Patients With Mar... | NCT00199290

Status Module

Record Verification Date

Feb 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Jul 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2008

Last Update Posted Date

Feb 5, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is designed to evaluate the efficacy and the safety of Trafermin(recombinant human basic fibroblast growth factor: rhbFGF) in Japanese patients with marginal periodontitis, in order to verify the superiority of Trafermin to placebo, and to determine the recommended therapeutic dose.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

267Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
P	Placebo Comparator		Drug: Trafermin (genetical recombination)
L	Experimental	low dose (0.2 %)	Drug: Trafermin (genetical recombination)
M	Experimental	medium dose (0.3 %)	Drug: Trafermin (genetical recombination)
H	Experimental	high dose (0.4 %)	Drug: Trafermin (genetical recombination)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trafermin (genetical recombination)	Drug		H L M P

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rate of increase in alveolar bone height		36 weeks after administration

Secondary Outcomes

Measure	Description	Time Frame
clinical attachment level regained		36 weeks after administration
time course of increase rate in alveolar bone height		within 36 weeks after administration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patient with marginal periodontitis intend to conduct a flap operation(modified Widman) must meet the following criteria:

Alveolar bone defect diagnosed by radiography.
Mobility of teeth must be <=2 and the width of attached gingiva is suitable for GTR(guided tissue regeneration) method.
Males and females, >=20 years of age.

Exclusion Criteria:

Patients will be excluded from the study if any of the following conditions are present:

Concomitant administration of adrenal cortical steroid within 4weeks of treatment in the trial.
Current or previous history of gingival overgrowth by drugs.
Current or previous history of cancer or malignant tumour.
Presence of diabetes mellitus(HbA1c>=6.5%)
Presence of malnutrition(serum albumin<=2g/dL)
Pregnancy or lactation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Makoto Tamura, Ph.D	Kaken Pharmaceutical Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaken Investigational Site		Nagoya	Aichi-ken	464-8651	Japan
Kaken Investigational Site

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases