Trial record 4 of 114 for:    Acromegaly

Use of Somatostatin Analogue Therapy as Primary Medical Treatment of Acromegaly

This study has been completed.
Sponsor:
Information provided by:
Plymouth Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00225134
First received: September 21, 2005
Last updated: July 22, 2011
Last verified: September 2005
  Purpose

This study is designed to investigate the use of the somatostatin analogue- Somatuline Autogel in the primary medical treatment of the condition Acromegaly.

Primary Objective: To test the hypothesis that a twelve month period of primary medical treatment of acromegaly with Somatuline Autogel will produce clinically significant reductions in tumour size from Baseline to Month 12 as assessed using MRI.


Condition Intervention Phase
Acromegaly
Drug: Somatuline Autogel
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Somatostatin Analogue Therapy as Primary Medical Treatment of Acromegaly

Resource links provided by NLM:


Further study details as provided by Plymouth Hospitals NHS Trust:

Primary Outcome Measures:
  • Reductions in tumour size from Baseline to Month 12 as assessed using MRI. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the change in tumour size at Month 3 and Month 6 compared to baseline assessed using MRI. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To assess the change in the GH and IGF-1 levels at all assessment timepoints in comparison to the baseline visit. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To assess the change in visual fields at all assessment timepoints in comparison to baseline, as assessed using a Goldman Visual Fields Analyser. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To assess the change in patient symptom scores at all assessment timepoints in comparison to the baseline visit as assessed using numerical rating scales. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To assess the change in quality of life scores (as assessed using the SF-36 questionnaire) at all assessment timepoints in comparison to the baseline visit. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To determine the incidence of occurrence of new hormonal axes defects arising pre-operatively between baseline and Month 12. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To determine the proportion of patients requiring surgery during the twelve month study period (i.e. those with tumour progression or intolerable symptoms on medical therapy). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To evaluation the safety and tolerability of each dose of Somatuline Autogel, as assessed by: [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • To evaluate the maximum tolerated dose for each patient, [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • To evaluate the incidence of adverse events (including findings on liver and gallbladder ultrasound), [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • To evaluate changes in concomitant medication, [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • To evaluate the incidence of clinically significant changes in vital signs or ECG, [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • To evaluate the incidence of clinically significant laboratory or physical examination findings. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: November 2005
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Somatuline Autogel
single-arm study with historical control group, to assess the efficacy and safety of primary medical treatment of Acromegaly with Somatuline Autogel
Drug: Somatuline Autogel
Patients will be treated for 12 months with Somatuline Autogel which is administered by deep sub-cutaneous injection.Injections will be performed every 28 days. The first dose administered will be 60 mg, if this is tolerated 90 mg will be used for the second injection and again, if the dose is tolerated then 120 mg will be given for the third and all subsequent injections.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must satisfy all of the following entry criteria before they will be allowed to participate in the study:

  • The patient must give written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of their normal medical care.
  • The patient is over 18 years of age inclusive.
  • The patient has active acromegaly as diagnosed by oral glucose tolerance test and IGF-1 measurement. Acromegaly must be confirmed prior to study entry based on failure to suppress GH during an oral glucose tolerance test and IGF-1 above the normal range.
  • The patient has a pituitary adenoma tumour size greater than 5 mm along the longest axis on MRI.
  • The patient has a life expectancy of at least 2 years.
  • The patient is able and willing to comply with the requirements of the protocol.

Exclusion Criteria:

  • The patient is considered unfit for surgery due to comorbidity that is unlikely to resolve with control of acromegaly.
  • The patient has a significant visual field defect thought to be due to optic chiasm compression at the time of presentation where the risk of visual loss is considered too great to delay surgery. (Note: Not all patients with visual field defects will be excluded - this decision will be made at the joint pituitary clinic). Following informed discussion with the individual medical therapy will be offered with close monitoring of visual fields as per protocol. If visual field assessment shows a further deterioration then surgery will be offered at that point. The available literature strongly supports the view that further tumour growth is unlikely during somatostatin analogue therapy.
  • The patient has a pituitary adenoma tumour of 5 mm or less along the longest axis, with margins clearly defined within pituitary fossa.
  • The patient has had any prior pituitary surgery (adenectomy).
  • The patient has received pituitary radiotherapy within one year prior to screening.
  • The patient has been previously treated with a GH antagonist or a somatostatin analogue.
  • The patient has clinically significant renal or hepatic abnormalities.
  • The patient has a known allergy or hypersensitivity to any of the test compounds or materials.
  • The patient is pregnant or lactating (female patients of child-bearing potential (i.e. who are not surgically sterile or at least 1 year post-last menstrual period) must have a negative urine pregnancy test at the baseline visit).
  • The patient is a female at risk of pregnancy during the study, not taking adequate precautions against pregnancy.
  • The patient has received any investigational drug therapy within 30 days prior to the study, or is scheduled to receive such a drug during the study period.
  • The patient has previously entered this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225134

Locations
United Kingdom
Dr D Flanagan
Plymouth, Devon, United Kingdom, PL6 8DH
Sponsors and Collaborators
Plymouth Hospitals NHS Trust
Investigators
Principal Investigator: Daniel E Flanagan, MD Plymouth Hospitals NHS Trust
  More Information

No publications provided

Responsible Party: Dr. Lisa Vickers, R&D Dept, Plymouth Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT00225134     History of Changes
Other Study ID Numbers: Sponsor Protocol no. AcMed 01
Study First Received: September 21, 2005
Last Updated: July 22, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by Plymouth Hospitals NHS Trust:
Acromegaly

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Somatostatin
Angiopeptin
Lanreotide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 24, 2014