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A Prospective Non-Interventional Study Protocol With Primary Data Collection - Assessment Of The Long Term Treatment Outcomes Of Genotropin Treatment In Growth Hormone Deficiency (GHD) Patients

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Growth Hormone Deficiency

Intervention: Non Interventional Study (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021


The purpose of this study is to assess the long term treatment outcomes of Growth Hormone treatment in patients who are prescribed and treated with Genotropin. Also, plan to determine the relationships between clinical status, dosage schedule and response to Genotropin treatment. This study will also contribute to our knowledge of adult Growth Hormone Deficiency, including transition period in Childhood Onset Growth Hormone Deficiency and its treatment.

Clinical Details

Official title: Swegho- A Prospective Non Interventional Study Protocol With Primary Data Collection -Assessment Of The Long Term Treatment Outcomes Of Genotropin Treatment In Ghd Patients In Sweden

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: This Non-Interventional study does not include pre-specified endpoints, but collects information from adult subjects recieving Genotropin treatment in a real world clinic setting.

Detailed description: Patients within inclusion criteria are asked to participate in the study.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Adult patients of 18 years of age and above and fulfilling one of the three

alternatives a-c below; 1. Newly diagnosed with GHD according to the current medical standard. 2. Diagnosed with GHD before 2013 and previously treated with Genotropin and followed in KIMS®. 3. Transition patients diagnosed with CO-GHD before 2013.

- Prescribed Genotropin at the time of inclusion.

- Evidence of a personally signed and dated informed consent document indicating that

the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Exclusion Criteria:

- Patients who participate in any concurrent clinical interventional trial where a

non-authorized or authorized study medication is used, during their participation in Swedish KIMS® Xtended. Concurrent studies which do not include any study interventional items (whether medications or devices) are allowed.

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Höglandssjukhuset, Eksjö SE-575 81, Sweden; Not yet recruiting

Landstinget Dalarna, Falun 791 82, Sweden; Recruiting

Sahlgrenska University hospital, Goteborg 413 45, Sweden; Recruiting

Landstinget i Kalmar Lan, Kalmar 392 85, Sweden; Recruiting

Central Hospital/ Department of Medicine, Kristianstad 291 85, Sweden; Recruiting

Universitetssjukhuset, EM-kliniken, Linköping 581 85, Sweden; Recruiting

Ljungby Lasarettet, Ljungby 341 82, Sweden; Recruiting

University Hospital SUS, Malmo 205 02, Sweden; Recruiting

Karolinska Universitetssjukhuset, Kliniken for Endokrinologi, Stockholm 171 76, Sweden; Recruiting

Landstinget i Stockholms Lan, Stockholm 118 83, Sweden; Not yet recruiting

Akademiska sjukhuset / Medicincentrum, Diabetes- och Endokrinsektionen, Uppsala 751 85, Sweden; Recruiting

Medicinkliniken, Centrallasarettet Vaxjo, Vaxjo 351 85, Sweden; Recruiting

Vastra Gotalands Regionen, Skovde, Skaraborg 541 85, Sweden; Recruiting

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: November 2013
Last updated: August 5, 2015

Page last updated: August 20, 2015

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