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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01278342
Other study ID # CSMS995BIC03
Secondary ID 2005-005852-42
Status Completed
Phase Phase 4
First received January 14, 2011
Last updated February 28, 2017
Start date September 2006
Est. completion date November 2009

Study information

Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date November 2009
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

• Patient with a biochemically documented active acromegaly, not adequately controlled by somatostatin-analogues at conventional regimen as follow : mean 1-hour GH > 2.5 ng/mL and elevated IGF-1 (adjusted for age and gender)

- Patient with reduction of either mean fasting GH at least 50% or IGF-1 at least 25% from any medical pretreatment level

- Patient currently receiving somatostatin-analogues at conventional regimen (maximum registered dose) for at least 6 months before inclusion

Exclusion Criteria:

- Newly diagnosed or previously medically untreated acromegalic patient

- Concomitant treatment with GH-receptor antagonist

- Concomitant treatment with dopamine-agonist

- Symptomatic cholelithiasis or choledocolithiasis

- Liver transaminases (ALT, AST) elevated, but > 3 times upper normal limit (according to local laboratory)

- Previous gamma-knife radiotherapy for treatment of acromegaly

- Compression of the optic chiasm causing visual field defect

- Any medical conditions contraindicated in the Summary of Product Characteristic (SPC) of all drugs

Other protocol-defined inclusion/exclusion criteria may apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sandostatin LAR
40 mg intramuscular (i.m.) every 28 days for 3 months
pegvisomant
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
cabergoline
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: st week: 0.25 mg twice a week (0.50 mg/week) nd week: 0.50 mg/week twice a week (1 mg/week) rd week: 0.50 mg four times a week (2 mg/week) th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)

Locations

Country Name City State
France Novartis Investigative Site Brest Cedex
France Novartis Investigative Site Bron Cedex
France Novartis Investigative Site Kremlin-Bicetre
France Novartis Investigative Site Nice
France Novartis Investigative Site Nimes
France Novartis Investigative Site Pessac
France Novartis Investigative Site Toulouse
Italy Novartis Investigative Site Genova
Italy Novarts Investigative Site Naples
Italy Novartis Investigative Site Napoli
Italy Novartis Investigative Site Padova
Italy Novartis Investigative Site Perugia
Italy Novartis Investigative Site Pisa
Italy Novartis Investigative Site Torino
Poland Novartis Investigative Site Lodz
Poland Novartis Investigative Site Warszawa
Poland Novartis Investigative Site Wroclaw
Poland Novartis Investigative Site Zabrze
Portugal Novartis Investigative Site Porto
Switzerland Novartis Investigative Site Lausanne

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

France,  Italy,  Poland,  Portugal,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Percentage of Participants With Complete Response (CR) at 8 Months A patient was classified as a Complete Responder (CR) if both biochemical parameters were controlled at the end of 8 months of treatment:
Mean 1 hour GH < 2.5µg/L (according to Central Laboratory); and
IGF-I within the Central Laboratory Normal Range (for age and gender).
From Baseline to 8 months
Secondary The Percentage of Participants With Complete Response (CR) At 3 Months A patient was classified as CR if both biochemical parameters were controlled at the end of 3 months of treatment:
Mean 1 hour GH < 2.5µg/L (according to Central Laboratory); and
IGF-I within the Central Laboratory Normal Range (for age and gender)
From Baseline to 3 months
Secondary The Percentage of Participants With Partial Response (PR) at 8 Months Patients who met one of the following criteria at the end of 8 months of treatment were defined as Partial Responders, regardless of the treatment.
Mean 1 hour GH > 2.5 µg/L and < 5 µg/L and either a decrease in IGF-I of at least 50% compared to baseline or IGF-I within normal range.
Mean 1 hour GH < 2.5 µg/L and a decrease in IGF-I of at least 50% compared to baseline and IGF-I outside normal range.
From Baseline to 8 months
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