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Completed

NCT Number: NCT00635765

Open Label Extension Study Evaluating Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients

The purpose of this study is to assess the safety profile of C2L-OCT-01 PR for up to an additional 96-week period in acromegalic patients who completed the C2L-OCT-01 PR-301 study.

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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Republican Centre for Medical Rehabilitation and Water-therapy, Minsk, Belarus

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

•Subjects who have completed the 24-week C2L-OCT-01 PR-301 study

Exclusion criteria

  • Women of childbearing potential who are not taking adequate contraception or who are pregnant or lactating
  • Subjects who have experienced any clinically significant adverse event related to study medication in C2L-OCT-01 PR-301 study
  • Subjects with uncontrolled Diabetes type II
  • Subjects with signs or symptoms related to a tumor compression of the optical chiasm
  • Subjects with symptomatic cholelithiasis

Treatment and study plan

C2L-OCT-01 PR 30 mg

Drug

Administered by deep IM (gluteus) on Day 1. Beginning on Day 42, drug injection frequency (6, 5 or 4 weeks) and dose modification/adjustment will be allowed for every 3 drug injections based on the mean serum GH and clinical symptoms obtained at the last visit of study C2L-OCT-01 PR-301 and during the course of this study.

Primary outcomes

  1. Assess, for up to an additional 96 weeks, the safety profile of C2L-OCT-01 PR administered intra muscularly every 6, 5 or 4 weeks in patients who have completed the C2L-OCT-01 PR-301 study.

    Time frame: Up to 96 weeks

Secondary outcomes

  1. To determine the percentage of patients who remain with controlled mean GH and normal (gender- and age-matched values) IGF-1 serum concentrations.

    Time frame: Up to 96 weeks

  2. Compare plasma concentrations of C2L-OCT-01 PR.

    Time frame: First 6 months

Sponsors and collaborators

Lead sponsor

Ambrilia Biopharma, Inc.

Industry

Registry information

Official study title

Open Label Extension Study Evaluating the Safety and Biological Activity of a New Prolonged Release Formulation of Octreotide Acetate, C2L-OCT-01 PR, Administered Intra Muscularly Every 6, 5 or 4 Weeks in Acromegalic Patients

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 14, 2008
Registry last updated
Jun 4, 2009

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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