Trial · Observational

CompletedPhase not statedResults postedRegistry data

Non Interventional Study For Patients Treated With Somavert®

Short name GPOS

NCTNCT00858143Other idA6291014

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Measures Pegvisomant, does not give it. It appears in an outcome measure.

Overview

Status: Completed
Phase: Phase not stated
Enrollment: 311 participants (actual)
Sponsor: Pfizer · Industry
Design: Not stated
Countries: Not stated
Start: Jan 2004
Primary completion: Jan 2008
Completion: Jan 2008
First posted: 9 Mar 2009 (estimated)
Last update posted: 2 Sept 2009 (estimated)
Conditions: Acromegaly

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200420052006200720082009

Ph –
GPOS
NCT00858143
Jan 2004 to Jan 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study was performed in order to examine the efficacy and safety of Somavert® in treatment of subjects with acromegaly and its effects on acromegaly related co-morbidities.

Interventions

Non Interventional ObservationOther

Arms1

Other
1

Primary outcomes1

Outcomes the sponsor listed as primary.

Serious Adverse Events (SAE) and Adverse Events (AE)
Time frame · Baseline up to 5 years
Registry description
Long term safety of Somavert in treatment of patients with acromegaly

Secondary outcomes(20)

Change From Baseline Insulin-like Growth Factor I (IGF-I)
Time frame · Baseline, Follow-up 1 (FUP 1) at ~6 months , Follow-up 2 (FUP 2) at ~12 months, Follow-up 3 (FUP 3) at ~ 24 months, Follow-up 4 (FUP 4) at ~ 36 months, Follow-up 5 (FUP 5) at ~ 48 months, Follow-up 6 (FUP 6)at ~60 months
Registry description
Change: IGF-I concentration at observation minus IGF-I concentration at baseline (local laboratory, different assay).
IGF-I Values Within Normal Range
Time frame · Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Registry description
Number of participants who have IGF-I values within normal range (local laboratory, different assay).
IGF-I Values Above Normal Range
Time frame · Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Registry description
Number of participants who have IGF-I values above normal range (local laboratory, different assay).
Change From Baseline Hemoglobin A 1c (HbA 1c)
Time frame · Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Registry description
Change: HbA 1c at observation minus HbA 1c at baseline.
HbA 1c Values Within Normal Range
Time frame · Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Registry description
Number of participants who have HbA 1c values within normal range.
HbA 1c Values Below Normal Range
Time frame · Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5), 60 months (FUP 6)
Registry description
Number of participants who have HbA 1c values below normal range.
HbA 1c Values Above Normal Range
Time frame · Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Registry description
Number of participants with HbA 1c values above normal range.
Change From Baseline Glucose (Fasting)
Time frame · Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Registry description
Change: glucose at observation minus glucose at baseline.
Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)>
Time frame · Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3)
Registry description
Change: glucose 2h oGTT at observation minus glucose 2h oGTT at baseline.
Glucose Values Within Normal Range (Fasting)
Time frame · Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Registry description
Number of participants who have glucose values within normal range (fasting).
Glucose Values Below Normal Range (Fasting)
Time frame · Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Registry description
Number of participants with glucose values below normal range (fasting).
Glucose Values Above Normal Range (Fasting)
Time frame · Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Registry description
Number of participants with glucose values above normal range (fasting).
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range
Time frame · Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Registry description
Number of participants with glucose values (2h oGTT) within normal range.
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range
Time frame · Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Registry description
Number of participants with glucose values (2h oGTT) above normal range.
IGF-I Absolute Values
Time frame · Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Registry description
IGF-I absolute values (local laboratory, different assay).
Absolute Glucose Values (Fasting)
Time frame · Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Registry description
Absolute Glucose values (fasting)
Absolute Glucose Values (2h oGTT)
Time frame · Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Registry description
Absolute Glucose values - 2 Hour Oral Glucose Tolerance Test (2h oGTT).
Absolute Hemoglobin A 1c (HbA 1c) Values
Time frame · Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Registry description
Absolute value Hemoglobin A 1c (HbA 1c)
Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
Time frame · Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Registry description
Change: IGF-I concentration at observation minus IGF-I concentration at baseline. (local laboratory, different assay).
Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
Time frame · Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Registry description
Absolute values Insulin-Like Growth Factor I (IGF-I) in Patients with Diabetes (local laboratory, different assay).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Secondary and other outcome results(8)

Secondary outcomeMean· Baseline, Follow-up 1 (FUP 1) at ~6 months , Follow-up 2 (FUP 2) at ~12 months, Follow-up 3 (FUP 3) at ~ 24 months, Follow-up 4 (FUP 4) at ~ 36 months, Follow-up 5 (FUP 5) at ~ 48 months, Follow-up 6 (FUP 6)at ~60 months

Change From Baseline Insulin-like Growth Factor I (IGF-I)

Group	Value (micrograms per liter (ug/l))	Spread
Somavert®	-200.3	239.1

Secondary outcomeNumber· Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

IGF-I Values Within Normal Range

Group	Value (participant)
Somavert®	59

Secondary outcomeNumber· Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

IGF-I Values Above Normal Range

Group	Value (participant)
Somavert®	207

Secondary outcomeMean· Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Change From Baseline Hemoglobin A 1c (HbA 1c)

Group	Value (percent (%))	Spread
Somavert®	-0.3	0.9

Secondary outcomeNumber· Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

HbA 1c Values Within Normal Range

Group	Value (participant)
Somavert®	104

Secondary outcomeNumber· Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5), 60 months (FUP 6)

HbA 1c Values Below Normal Range

Group	Value (participants)
Somavert®	0

Secondary outcomeNumber· Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

HbA 1c Values Above Normal Range

Group	Value (participants)
Somavert®	69

Secondary outcomeMean· Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Change From Baseline Glucose (Fasting)

Group	Value (milligram per deciliter (mg/dl))	Spread
Somavert®	-11.6	39.6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Somavert®Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)	–	116 / ?	197 / ?

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Subjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study. Exclusion Criteria: * Subjects treated with an investigational drug for treatment of acromegaly. * Subjects with symptoms such visual field loss, cranial nerve palsies or intracranial hypertension, indicating need for surgery. * Women who were pregnant or lactating.

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