Trial Outcomes & Findings for Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly (NCT NCT00372697)

NCT ID: NCT00372697

Last Updated: 2011-05-17

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 28 participants
• Primary outcome timeframe: Screening to end of study (Week 24)
• Results posted on: 2011-05-17

Participant Flow

Participant milestones

Measure	Octreotide 30 mg Every 21 Days Participants 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.	Octreotide 60 mg Every 28 Days Participants 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.
Overall Study STARTED	16	12
Overall Study COMPLETED	15	11
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Octreotide 30 mg Every 21 Days Participants 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.	Octreotide 60 mg Every 28 Days Participants 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.
Overall Study Protocol Violation	1	1

Baseline Characteristics

Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly

Baseline characteristics by cohort

Measure	Octreotide 30 mg Every 21 Days n=16 Participants Participants 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.	Octreotide 60 mg Every 28 Days n=12 Participants Participants 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.	Total n=28 Participants Total of all reporting groups
Age Continuous	51.3 years STANDARD_DEVIATION 12.1 • n=5 Participants	51.8 years STANDARD_DEVIATION 15.7 • n=7 Participants	51.5 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Screening to end of study (Week 24)

Population: Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and who had at least one post-baseline evaluation of the primary variable.

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.

Outcome measures

Measure	Octreotide 30 mg Every 21 Days n=15 Participants Participants 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.	Octreotide 60 mg Every 28 Days n=11 Participants Participants 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.
Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24)	-1.7 µg/L Standard Deviation 9.9	-2.1 µg/L Standard Deviation 3.6

PRIMARY outcome

Timeframe: Screening to end of study (Week 24)

Population: Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and who had at least one post-baseline evaluation of the primary variable.

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

Outcome measures

Measure	Octreotide 30 mg Every 21 Days n=15 Participants Participants 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.	Octreotide 60 mg Every 28 Days n=11 Participants Participants 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.
Change in Insulin-like Growth Factor 1 (IGF-1) Level From Screening to End of Study (Week 24)	-40.4 µg/L Standard Deviation 180.2	-135.0 µg/L Standard Deviation 170.9

SECONDARY outcome

Timeframe: Screening to end of study (Week 24)

Population: Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication and who had data for this outcome measure.

A pre-treatment magnetic resonance image (MRI) assessment of the pituitary area was required within 12 weeks prior to Screening as a baseline evaluation. A second MRI was performed at the end of the study (Week 24). All MRIs were performed according to protocol-defined guidelines. The tumor volume (mm^3) was calculated from measurements obtained in 3 axes from the MRI images.

Outcome measures

Measure	Octreotide 30 mg Every 21 Days n=14 Participants Participants 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.	Octreotide 60 mg Every 28 Days n=9 Participants Participants 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.
Change in Tumor Volume From Screening to End of Study (Week 24)	15.9 mm^3 Standard Deviation 91.8	-0.4 mm^3 Standard Deviation 21.0

SECONDARY outcome

Timeframe: Screening to end of study (Week 24)

Population: Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication and who had data for this outcome measure.

A pre-treatment magnetic resonance image (MRI) assessment of the pituitary area was required within 12 weeks prior to Screening as a baseline evaluation. A second MRI was performed at the end of the study (Week 24). All MRIs were performed according to protocol-defined guidelines. The tumor volume (mm^3) was calculated from measurements obtained in 3 axes from the MRI images.

Outcome measures

Measure	Octreotide 30 mg Every 21 Days n=14 Participants Participants 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.	Octreotide 60 mg Every 28 Days n=9 Participants Participants 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.
Percentage of Participants With > 20% Tumor Shrinkage From Screening to End of Study (Week 24)	14.3 Percentage of participants 6426	11.1 Percentage of participants 4211

SECONDARY outcome

Timeframe: Week 12 and end of study (Week 24)

Population: Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication.

The investigator asked the participant to score the following symptoms of acromegaly: Headache, perspiration, paresthesia, fatigue, osteoarthralgia, and carpal tunnel syndrome on a 5-point scale (0=absent; 1=mild; 2=moderate; 3=severe, but not disabling; 4=severe and disabling). The percentage of asymptomatic participants, ie, with a score of 0 for all symptoms, was calculated.

Outcome measures

Measure	Octreotide 30 mg Every 21 Days n=15 Participants Participants 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.	Octreotide 60 mg Every 28 Days n=11 Participants Participants 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.
Percentage of Participants Asymptomatic for Acromegaly Symptoms at Week 12 and End of Study (Week 24) Week 12	33.3 Percentage of participants	9.09 Percentage of participants
Percentage of Participants Asymptomatic for Acromegaly Symptoms at Week 12 and End of Study (Week 24) Week 24	20.0 Percentage of participants	9.09 Percentage of participants

SECONDARY outcome

Timeframe: End of study (Week 24)

Population: Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication.

The AcroQoL contains 8 items on Physical aspects. Participants were asked to rate each item on a 1-5 Likert scale measuring either the frequency of occurrence (always, most of the time, sometimes, rarely, or never) or the degree of agreement (completely agree, moderately agree, neither agree nor disagree, moderately disagree, completely disagree). The score on the physical scale can range from 8-40. A higher score indicates better Quality of Life.

Outcome measures

Measure	Octreotide 30 mg Every 21 Days n=15 Participants Participants 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.	Octreotide 60 mg Every 28 Days n=11 Participants Participants 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.
Acromegaly Quality of Life (AcroQoL) Questionnaire Physical Scale Score at End of Study (Week 24)	67.9 Percent of maximum score Standard Deviation 22.6	58.0 Percent of maximum score Standard Deviation 21.8

SECONDARY outcome

Timeframe: End of study (Week 24)

Population: Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication and who had data for this outcome measure.

The AcroQoL contains 14 items on Psychological aspects. Participants were asked to rate each item on a 1-5 Likert scale measuring either the frequency of occurrence (always, most of the time, sometimes, rarely, or never) or the degree of agreement (completely agree, moderately agree, neither agree nor disagree, moderately disagree, completely disagree). The score on the psychological scale ranges from 14-70. A higher score indicates better Quality of Life.

Outcome measures

Measure	Octreotide 30 mg Every 21 Days n=15 Participants Participants 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.	Octreotide 60 mg Every 28 Days n=10 Participants Participants 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.
Acromegaly Quality of Life (AcroQoL) Questionnaire Psychological Scale Score at End of Study (Week 24)	65.1 Percent of maximum score Standard Deviation 19.9	72.1 Percent of maximum score Standard Deviation 19.6

Adverse Events

Octreotide 30 mg Every 21 Days

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Octreotide 60 mg Every 28 Days

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Octreotide 30 mg Every 21 Days n=16 participants at risk Participants 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.	Octreotide 60 mg Every 28 Days n=12 participants at risk Participants 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.
Gastrointestinal disorders Diarrhoea	6.2% 1/16 • Number of events 1	16.7% 2/12 • Number of events 2
Gastrointestinal disorders Flatulence	12.5% 2/16 • Number of events 2	0.00% 0/12

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862 778-8300

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER