AcromegalyGPOSNCT00858143
Non Interventional Study For Patients Treated With Somavert®
An observational study of Acromegaly, run by Pfizer.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Non Interventional Observation
- How many people
- 311 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Jan 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study.
Who may be able to join
- Subjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study.
Who cannot join
- 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.
About this study
Official title: German Non Interventional Study For Patients Treated With Somavert®
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.
Read the detailed description
Non probability samples
- Conditions
- Acromegaly
- Being tested
- Non Interventional Observation
- Keywords
- Open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Interventional ObservationOther
Post marketing surveillance study = prospective, non-interventional observation of the use of Somavert®
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Other: Non Interventional Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events (SAE) and Adverse Events (AE)
Long term safety of Somavert in treatment of patients with acromegaly
Measured: Baseline up to 5 years
Secondary outcomes (45)
Change From Baseline Insulin-like Growth Factor I (IGF-I)
Change: IGF-I concentration at observation minus IGF-I concentration at baseline (local laboratory, different assay).
Measured: 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
IGF-I Values Within Normal Range
Number of participants who have IGF-I values within normal range (local laboratory, different assay).
Measured: 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
Number of participants who have IGF-I values above normal range (local laboratory, different assay).
Measured: 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)
Change: HbA 1c at observation minus HbA 1c at baseline.
Measured: 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
Number of participants who have HbA 1c values within normal range.
Measured: 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 Below Normal Range
Number of participants who have HbA 1c values below normal range.
Measured: 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 Above Normal Range
Number of participants with HbA 1c values above normal range.
Measured: 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)
Change: glucose at observation minus glucose at baseline.
Measured: 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 <(2 Hour Oral Glucose Tolerance Test (2h oGTT)>
Change: glucose 2h oGTT at observation minus glucose 2h oGTT at baseline.
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3)
Glucose Values Within Normal Range (Fasting)
Number of participants who have glucose values within normal range (fasting).
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Glucose Values Below Normal Range (Fasting)
Number of participants with glucose values below normal range (fasting).
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Glucose Values Above Normal Range (Fasting)
Number of participants with glucose values above normal range (fasting).
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range
Number of participants with glucose values (2h oGTT) within normal range.
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range
Number of participants with glucose values (2h oGTT) above normal range.
Measured: 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 Absolute Values
IGF-I absolute values (local laboratory, different assay).
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Absolute Glucose Values (Fasting)
Absolute Glucose values (fasting)
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Absolute Glucose Values (2h oGTT)
Absolute Glucose values - 2 Hour Oral Glucose Tolerance Test (2h oGTT).
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Absolute Hemoglobin A 1c (HbA 1c) Values
Absolute value Hemoglobin A 1c (HbA 1c)
Measured: 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 Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
Change: IGF-I concentration at observation minus IGF-I concentration at baseline. (local laboratory, different assay).
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
Absolute values Insulin-Like Growth Factor I (IGF-I) in Patients with Diabetes (local laboratory, different assay).
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients
Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Within Normal Range (local laboratory, different assay).
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients
Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Above Normal Range (local laboratory, different assay).
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients
Absolute Values for Hemoglobin A 1c (HbA 1c) in Patients with Diabetes
Measured: 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) in Diabetic Patients
Change: HbA 1c at observation minus HbA 1c at baseline.
Measured: 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 in Diabetic Patients
Number of Diabetic Patients with HbA 1c Values Within Normal Range.
Measured: 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 Below Normal Range in Diabetic Patients
Number of Diabetic Patients with HbA 1c Values Below Normal Range
Measured: 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 in Diabetic Patients
Number of Diabetic Patients with HbA 1c Values Above Normal Range
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Glucose Change From Baseline in Diabetic Patients (Fasting)
Change: glucose at observation minus glucose at baseline
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Absolute Glucose Values in Diabetic Patients (Fasting)
Absolute Glucose Values in Patients with Diabetes (fasting)
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Glucose Values Within Normal Range in Diabetic Patients (Fasting)
Number of Diabetic Patients (fasting) with Glucose Values Within Normal Range
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Glucose Values Above Normal Range in Diabetic Patients (Fasting)
Number of Diabetic Patients (fasting) with Glucose Values Above Normal Range
Measured: 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 in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Change: score at observation minus score at baseline. Headache symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Change: score at observation minus score at baseline. Excessive sweating symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Change: score at observation minus score at baseline. Joint pain symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Change: score at observation minus score at baseline. Fatigue symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Change: score at observation minus score at baseline. Soft tissue swelling symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Change: score at observation minus score at baseline. Numbness or tingling of limbs symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Change: score at observation minus score at baseline. General physical condition symptom in PASQ: disease-specific questionnaire based on the previous 6 questions which evaluated headache, excessive sweating, joint pain, fatigue, soft tissue swelling and numbness or tingling of limbs. Scoring 0-10 (0 = worst and 10 = best possible).
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Total PASQ score: total score calculated as sum of items 1-6; range is 0-48. Change from baseline calculated as total score at observation minus total score at baseline. PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Mean Change From Baseline for Body Weight
Change: body weight at observation minus body weight at baseline
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
Change From Baseline for Diastolic Blood Pressure (BP)
Change: diastolic blood pressure at observation minus diastolic blood pressure at baseline
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
Change From Baseline for Systolic Blood Pressure (BP)
Change: systolic blood pressure at observation minus systolic blood pressure at baseline
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
Change From Baseline in Ring Size
Change from baseline: ring size at observation minus ring size at baseline
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the Safety Population
Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender.
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the ITT Population
Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender.
Measured: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startJan 2004
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858143
- Sponsor's protocol ID
- A6291014
- Acronym
- GPOS
- Status last verified
- Mar 2009
- First submitted
- 6 Mar 2009
- Last updated
- 2 Sep 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German Non Interventional Study For Patients Treated With Somavert®
- ClinicalTrials.gov ID
- NCT00858143
- Acronym / sponsor ID
- GPOS / A6291014
- Conditions
- Acromegaly
- Keywords
- Open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 9 Mar 2009 (estimated)
- Results
- Posted 12 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Non probability samples
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Non Interventional Observation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study.
Key inclusion criteria (1 listed)
- Subjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non Interventional ObservationPost marketing surveillance study = prospective, non-interventional observation of the use of Somavert® | Other | 1 |
Primary outcome
Serious Adverse Events (SAE) and Adverse Events (AE)
Time frame: Baseline up to 5 years
Long term safety of Somavert in treatment of patients with acromegaly
45 secondary outcomes
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range 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)
Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range 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)
Absolute Values for Hemoglobin A 1c (HbA 1c) 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)
Change From Baseline Hemoglobin A 1c (HbA 1c) 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)
HbA 1c Values Within Normal Range 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)
HbA 1c Values Below Normal Range 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)
HbA 1c Values Above Normal Range 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)
Glucose Change From Baseline in Diabetic Patients (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)
Absolute Glucose Values in Diabetic Patients (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)
Glucose Values Within Normal Range in Diabetic Patients (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)
Glucose Values Above Normal Range in Diabetic Patients (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)
Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Mean Change From Baseline for Body Weight
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (SAE) and Adverse Events (AE) (time frame: Baseline up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2009.