N/A N=311

Non Interventional Study For Patients Treated With Somavert®

Acromegaly

Bottom Line

View on ClinicalTrials.gov: NCT00858143 ↗

Enrolled (actual)

311

Serious AEs

—

Results posted

Aug 2009

Primary outcome: Primary: Serious Adverse Events (SAE) and Adverse Events (AE) — 116; 197 participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Non Interventional Observation (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Jan 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Serious Adverse Events (SAE) and Adverse Events (AE)	116; 197	—
SECONDARY Change From Baseline Insulin-like Growth Factor I (IGF-I)	-200.3; -202.6; -273.7; -319.6; -296.6	—
SECONDARY IGF-I Values Within Normal Range	59; 156; 154; 108; 56; 14	—
SECONDARY IGF-I Values Above Normal Range	207; 105; 68; 39; 23; 7	—
SECONDARY Change From Baseline Hemoglobin A 1c (HbA 1c)	-0.3; -0.3; -0.3; -0.3; -0.0	—
SECONDARY HbA 1c Values Within Normal Range	104; 85; 78; 57; 30; 7	—
SECONDARY HbA 1c Values Below Normal Range	0; 1; 1; 1; 0; 0	—
SECONDARY HbA 1c Values Above Normal Range	69; 46; 48; 24; 13; 3	—
SECONDARY Change From Baseline Glucose (Fasting)	-11.6; -14.2; -19.7; -12.9; -10.5	—
SECONDARY Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)>	-1.5; -56.8; -61.3	—
SECONDARY Glucose Values Within Normal Range (Fasting)	116; 103; 93; 65; 25; 6	—
SECONDARY Glucose Values Below Normal Range (Fasting)	2; 3; 1; 1; 0; 0	—
SECONDARY Glucose Values Above Normal Range (Fasting)	54; 26; 23; 12; 10; 2	—
SECONDARY Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range	5; 3; 3; 3; 0; 0	—
SECONDARY Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range	2; 1; 0; 0; 0; 0	—
SECONDARY IGF-I Absolute Values	480.1; 277.2; 281.6; 240.6; 236.1; 241.8	—
SECONDARY Absolute Glucose Values (Fasting)	112.6; 104.5; 98.7; 95.2; 105.9; 107.5	—
SECONDARY Absolute Glucose Values (2h oGTT)	130.6; 145.3; 108.1; 112.6	—
SECONDARY Absolute Hemoglobin A 1c (HbA 1c) Values	6.2; 6.0; 6.1; 6.0; 6.1; 6.1	—
SECONDARY Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients	-207.5; -194.5; -274.6; -314.9; -90.5	—
SECONDARY Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients	478.8; 276.4; 293.2; 239.3; 242.5; 311.3	—
SECONDARY Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients	14; 41; 47; 35; 16; 3	—
SECONDARY Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients	67; 39; 27; 14; 10; 2	—
SECONDARY Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients	7.0; 6.6; 6.5; 6.6; 6.6; 6.6	—
SECONDARY Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients	-0.4; -0.5; -0.5; -0.6; -0.2	—
SECONDARY HbA 1c Values Within Normal Range in Diabetic Patients	24; 25; 24; 17; 10; 3	—
SECONDARY HbA 1c Values Below Normal Range in Diabetic Patients	0; 1; 1; 0; 0; 0	—
SECONDARY HbA 1c Values Above Normal Range in Diabetic Patients	48; 38; 37; 21; 12; 2	—
SECONDARY Glucose Change From Baseline in Diabetic Patients (Fasting)	-17.2; -24.9; -50.7; -14.8; -17.7	—
SECONDARY Absolute Glucose Values in Diabetic Patients (Fasting)	142.1; 131.0; 112.9; 101.9; 130.6; 120.7	—
SECONDARY Glucose Values Within Normal Range in Diabetic Patients (Fasting)	24; 28; 25; 18; 6; 2	—
SECONDARY Glucose Values Above Normal Range in Diabetic Patients (Fasting)	33; 19; 17; 7; 8; 1	—
SECONDARY Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)	-0.3; -0.4; -0.2; -0.7	—
SECONDARY Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)	-0.1; -0.4; -0.0; -0.8	—
SECONDARY Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)	-0.6; -0.2; 0.0; 0.6	—
SECONDARY Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)	0.2; -0.5; -0.4; -0.4	—
SECONDARY Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)	-0.6; -0.8; -0.8; -1.2	—
SECONDARY Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)	-0.7; -0.6; -0.6; -0.8	—
SECONDARY Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)	-0.6; -0.6; -0.6; -0.5	—
SECONDARY Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)	-2.3; -2.7; -2.0; -3.5	—
SECONDARY Mean Change From Baseline for Body Weight	0.0; 0.6; 2.1; 1.6; 3.0	—
SECONDARY Change From Baseline for Diastolic Blood Pressure (BP)	-1.0; -1.2; -1.5; 1.8; 2.5	—
SECONDARY Change From Baseline for Systolic Blood Pressure (BP)	-0.1; -2.9; -4.3; 2.1; 8.4	—
SECONDARY Change From Baseline in Ring Size	0.2; -0.8; -0.3; -6.1; 0.0	—
SECONDARY Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the Safety Population	16.8	—
SECONDARY Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the ITT Population	16.4	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00858143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.