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Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease

NCT00072839 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-05-25

No results posted yet for this study

Summary

The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.

Conditions

Interventions

DRUG

ALX-0600

teduglutide

DRUG

placebo

placebo solution injected subcutaneously

DRUG

teduglutide 0.05

0.05 mg/jg/d subcutaneous daily injection into thigh or abdomen

DRUG

teduglutide 0.2 mg

0.2 mg/kg/d subcutaneously injected into thigh or abdomen

DRUG

Teduglutide 0.05 dose

0.05 mg/kg/d subcutaneous daily injection into thigh or abdomen

DRUG

teduglutide 0.1 mg dose

0.1 mg/kg/d daily subcutaneous injection into thigh or abdomen

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-12
Primary Completion
2005-07-28
Completion
2005-07-28

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00072839 on ClinicalTrials.gov