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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00635765

Enrollment

Registered

2008-03-14

Start date

2007-10-31

Completion date

2009-06-30

Last updated

2009-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

Keywords

Acromegaly

Brief summary

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.

Interventions

DRUGC2L-OCT-01 PR 30 mg

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.	Up to 96 weeks

Secondary

Measure	Time frame
To determine the percentage of patients who remain with controlled mean GH and normal (gender- and age-matched values) IGF-1 serum concentrations.	Up to 96 weeks
Compare plasma concentrations of C2L-OCT-01 PR.	First 6 months

Countries

Belarus, Hungary, Romania, Serbia, Slovakia, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026