NCT00372697

Brief Summary

This study evaluated the safety and efficacy of an increased frequency of octreotide acetate injections or an increase in dose in partially responsive acromegalic patients with persistently uncontrolled disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

May 17, 2011

Completed
Last Updated

May 17, 2011

Status Verified

April 1, 2011

Enrollment Period

1.8 years

First QC Date

September 6, 2006

Results QC Date

January 12, 2011

Last Update Submit

April 19, 2011

Conditions

Acromegaly

Keywords

acromegalyoctreotide acetatepartial responder patients

Outcome Measures

Primary Outcomes (2)

  • Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24)

    Growth hormone (GH) level was the average value measured in 3 blood samples collected at 15 minute intervals at each visit. GH was measured with an automated immunometric assay in a central laboratory.

    Screening to end of study (Week 24)

  • Change in Insulin-like Growth Factor 1 (IGF-1) Level From Screening to End of Study (Week 24)

    Insulin-like growth factor 1 (IGF-1) level was measured in a blood sample with an automated immunometric assay in a central laboratory.

    Screening to end of study (Week 24)

Secondary Outcomes (5)

  • Change in Tumor Volume From Screening to End of Study (Week 24)

    Screening to end of study (Week 24)

  • Percentage of Participants With > 20% Tumor Shrinkage From Screening to End of Study (Week 24)

    Screening to end of study (Week 24)

  • Percentage of Participants Asymptomatic for Acromegaly Symptoms at Week 12 and End of Study (Week 24)

    Week 12 and end of study (Week 24)

  • Acromegaly Quality of Life (AcroQoL) Questionnaire Physical Scale Score at End of Study (Week 24)

    End of study (Week 24)

  • Acromegaly Quality of Life (AcroQoL) Questionnaire Psychological Scale Score at End of Study (Week 24)

    End of study (Week 24)

Study Arms (2)

Octreotide 30 mg every 21 days

EXPERIMENTAL

Patients received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.

Drug: Octreotide acetate 30 mg suspension

Octreotide 60 mg every 28 days

EXPERIMENTAL

Patients received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.

Drug: Octreotide acetate 30 mg suspension

Interventions

Octreotide acetate 30 mg suspensionDRUG

Each vial of study medication contained octreotide acetate 30 mg in a microencapsulated biodegradable polymer, poly (DL-lactide-co-glycolide) (D-(+)glucose), with 17% w/w mannitol in an approximate octreotide:polymer ratio of 1:20. The vehicle contained 0.5% sodium carboxymethylcellulose.

Also known as: Sandostatin LAR
Octreotide 30 mg every 21 daysOctreotide 60 mg every 28 days

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written voluntary informed consent.
  • Patients with biochemically documented active acromegaly who are currently receiving somatostatin-analogues in a conventional treatment regimen (octreotide up to 30 mg/28 days; lanreotide up to 120 mg/28 days) for at least 6 months.
  • Patients with uncontrolled disease defined as patients with a decrease of baseline levels of growth hormone (GH) ≥ 50% during treatment with somatostatin-analogues in a conventional regimen (sandostatin up to 30 mg/28 days; lanreotide up to 120 mg/28 days) for at least 6 months.
  • Baseline (mean of 3 samples) GH level \> 2 µg/L.
  • Insulin-like Growth Factor I (IGF-I) levels above the upper limits of normal for age and gender.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Brescia, Italy

Location

Related Publications (1)

  • Mazziotti G, Porcelli T, Bogazzi F, Bugari G, Cannavo S, Colao A, Cozzi R, De Marinis L, degli Uberti E, Grottoli S, Minuto F, Montini M, Spinello M, Giustina A. Effects of high-dose octreotide LAR on glucose metabolism in patients with acromegaly inadequately controlled by conventional somatostatin analog therapy. Eur J Endocrinol. 2011 Mar;164(3):341-7. doi: 10.1530/EJE-10-0811. Epub 2011 Jan 6.

    PMID: 21212103DERIVED

MeSH Terms

Conditions

Acromegaly

Interventions

OctreotideSuspensions

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862 778-8300

Study Officials

  • Novartis

    Novartis

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 7, 2006

Study Start

December 1, 2005

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

May 17, 2011

Results First Posted

May 17, 2011

Record last verified: 2011-04

Locations

IT(1)