MedDataX Logo

Treatment of Adults With Growth Hormone Deficiency

NCT ID: NCT00596037

Last Updated: 2012-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this rollover study is to evaluate the long term (1 year) safety of a new weekly administered growth hormone preparation in adults with growth hormone deficiency who were treated with the same experimental preparation in study BPLG-005. In addition, further change in efficacy endpoints of BPLG-005 by prolonged treatment will be evaluated. Additional efficacy and safety data of the experimental preparation will be obtained from the switch-over patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pituitary Disorders Adult Growth Hormone Deficiency

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Growth hormone Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LB03002 throughout

administered LB03002 for preceding 26 weeks

Group Type EXPERIMENTAL

Growth hormone - LB03002

Intervention Type DRUG

Switched to LB03002

administered placebo for preceding 26 weeks

Group Type EXPERIMENTAL

Growth hormone - LB03002

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Growth hormone - LB03002

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients (male and female) who have completed the Visit 8 of preceding main study (BPLG-005) and are willing to continue their participation in an extension study
* If female, women of child-bearing potential who are using a reliable method of contraception and be willing to use it throughout the study. A negative urine pregnancy test at Visit 0 is required for females of child-bearing potential
* Written informed consent of the patient

Exclusion Criteria

* Evidence of active malignancy or growth of a previously stable tumor
* Benign intracranial hypertension
* Clinically significant respiratory, cardiac, hepatic, renal, neuromuscular disease
* Non-compliance with medications, un-cooperativeness or drug abuse during the BPLG-005 study
* Patients who are not able to comply with the study protocol for any reason
Minimum Eligible Age

23 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

BioPartners GmbH

INDUSTRY

Sponsor Role collaborator

LG Life Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

HJ Ji, PhD

Role: STUDY_CHAIR

LG Life Sciences

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BPLG-005-RO

Identifier Type: -

Identifier Source: org_study_id