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Completed

NCT Number: NCT00199290

A Phase2 Clinical Trial of Trafermin in Patients With Marginal Periodontitis in Japan

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kaken Investigational Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trafermin (genetical recombination)

Drug

Primary outcomes

  1. rate of increase in alveolar bone height

    Time frame: 36 weeks after administration

Secondary outcomes

  1. clinical attachment level regained

    Time frame: 36 weeks after administration

  2. time course of increase rate in alveolar bone height

    Time frame: within 36 weeks after administration

  3. time course of clinical attachment level regained

    Time frame: within 36 weeks after administration

  4. occurrence and level of adverse reaction

    Time frame: within 36 weeks after administration

  5. serum anti-Trafermin antibody level

    Time frame: within 4 weeks

  6. serum Trafermin level

    Time frame: within 24 hours

Sponsors and collaborators

Lead sponsor

Kaken Pharmaceutical

Industry

Registry information

Official study title

A Phase 2, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and the Safety of Trafermin in Patients With Marginal Periodontitis in Japan

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Feb 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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