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A Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas

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ClinicalTrials.gov Identifier: NCT03309319
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Zhaoyun Zhang, Huashan Hospital

Tracking Information
First Submitted Date  ICMJE October 2, 2017
First Posted Date  ICMJE October 13, 2017
Last Update Posted Date October 13, 2017
Actual Study Start Date  ICMJE October 16, 2016
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2017)
  • Growth hormone(GH) [ Time Frame: 6 months ]
    the decrease of growth hormone(GH)
  • insulin like factor 1(IGF-1) [ Time Frame: 6 months ]
    the decrease of insulin like factor 1(IGF-1)
  • tumor volume [ Time Frame: 6 months ]
    the change of tumor volume
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas
Official Title  ICMJE A Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas
Brief Summary Growth hormone secreting pituitary adenomas(GHomas) produce excessive GH, stimulating excessive insulin like growth factor 1(IGF-1) synthesis in the liver, thus causing multiple systemic complications. The life expectancy of patients with untreated GHomas is shortened by ten years. The treatment goal of GHomas is to shrink the tumor volume and normalize GH and IGF-1. Under current treatment, only 50-70% of patients get remission. Rosiglitazone is a widely used oral antidiabetic medicine. The investigator's preliminary data showed that rosiglitazone decreased the synthesis of GH and IGF-1 in rat pituitary tumor cells GH3 and hepatocytes respectively. The investigator plan to investigate the efficacy of rosiglitazone in the treatment of patients with GHomas who have not been alleviated by other therapies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pituitary Tumor
Intervention  ICMJE Drug: Rosiglitazone
rosiglitazone is added to the primary treatment
Study Arms  ICMJE Experimental: Ros
Rosiglitazone:2 times a day, 4mg each time(4mgBid)
Intervention: Drug: Rosiglitazone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2017)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with GHomas confirmed by surgery
  • Patients who did not get biochemical remission: GH nadir after oral glucose tolerance test(OGTT)>1.0ug/L or IGF-1 exceeds age matched normal range

Exclusion Criteria:

  • Patients who were allergic to rosiglitazone
  • Patients with liver or kidney dysfunction, respiratory failure
  • Patients with heart failure
  • Patients with edema
  • Patients with severe hyperlipidemia
  • Patients with osteoporosis or a history of non traumatic fractures
  • Patients with pregnancy and lactation
  • Patients who had received radiation therapy within 3 years
  • Patients who had participated in other clinical trials within 3 months
  • Patients with other neoplastic diseases
  • Patients with mental and neurological disorders
  • Patients with other conditions which were believed not appropriate to take part in the clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03309319
Other Study ID Numbers  ICMJE KY2016-360
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhaoyun Zhang, Huashan Hospital
Study Sponsor  ICMJE Zhaoyun Zhang
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Huashan Hospital
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP