CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 70 enrolled
Drug / intervention
Sandostatin LAR +2 moredrug
Likely dose
Sandostatin LAR 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01278342
NCT01278342Phase 4Completed
CompareCT.gov

An Open-label, Two-step, Multicenter European Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients Not Adequately Controlled by Conventional Regimen

Novartis Pharmaceuticals·interventional·Posted Jan 17, 2011·Updated Mar 3, 2017

In Brief

A Phase 4 clinical trial evaluating Sandostatin LAR, pegvisomant, and 1 other intervention for Acromegaly. Completed, enrolled 70 participants across 20 sites in 5 countries.

Detailed Summary

This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone antagonist or dopamine agonist to control biochemical parameters (GH and insulin-like growth factor I \[IGF I\]) of acromegalic patients not achieving biochemical normalization at conventional regimen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcromegaly
CountriesFrance, Italy, Poland, Portugal, Switzerland
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 17, 2011
Enrollment StartSep 1, 2006
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 15.5 years ago

Interventions

Sandostatin LARdrug

40 mg intramuscular (i.m.) every 28 days for 3 months

pegvisomantdrug

Weekly doses of pegvisomant 70 mg subcutaneously (s.c.) for 4 months given with Sandostatin LAR 40 mg intramuscular (i.m.) every 28 days for 4 months

cabergolinedrug

Weekly cabergoline for 4 months, with weekly doses of Sandostatin LAR 40 mg intramuscular (i.m.) every 28 days for 4 months. Cabergoline doses as follows: 1. st week: 0.25 mg twice a week (0.50 mg/week) 2. nd week: 0.50 mg/week twice a week (1 mg/week) 3. rd week: 0.50 mg four times a week (2 mg/week) 4. th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)