MedTrace Logo

Efficacy and Safety of C2L-OCT-01 PR in Acromegalic Patients

NCT00616551 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2008-10-08

No results posted yet for this study

Summary

The purpose of this study is to assess the biological safety and efficacy of using the drug, C2L-OCT-01 PR, 30 mg to treat acromegalic patients.

Conditions

Interventions

DRUG

C2L-OCT-01 PR, 30 mg

Administered by deep IM injection (gluteus) on days 1 and 42

DRUG

Octreotide acetate prolonged release, 30 mg

Administered by deep IM (gluteus) on Days 1, 28 and 56

Sponsors & Collaborators

  • Ambrilia Biopharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Raphael Naudin, M.D. · Ambrilia Biopharma, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • Belarus
  • Hungary
  • Romania
  • Serbia
  • Slovakia
  • Ukraine

Study Locations

More Related Trials

Entities

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 NCT00616551 on ClinicalTrials.gov