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A Survey Collecting Data on Adult Height in Patients With Achondroplasia Treated With Somatropin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01435629
Recruitment Status : Completed
First Posted : September 16, 2011
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date September 14, 2011
First Posted Date September 16, 2011
Last Update Posted Date May 5, 2017
Actual Study Start Date November 22, 2012
Actual Primary Completion Date December 4, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 15, 2011)
To collect change data of adult height (cm) of patients treated with Norditropin® and evaluate the long-term efficacy [ Time Frame: At year 1, 2, 3, 4, and 5 after the patient has reached adult height or is 18 of age ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01435629 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 15, 2011)
To monitor the patients to see if they undergo lower limb lengthening [ Time Frame: At year 1, 2, 3, 4, and 5 after the patient has reached adult height or is 18 of age ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Survey Collecting Data on Adult Height in Patients With Achondroplasia Treated With Somatropin
Official Title Open-label, Multicenter, Observational, Non-intervention Study to Retrospectively Evaluate the Efficacy of Norditropin® (Adult Height) in Patients With Achondroplasia/Hypochondroplasia Enrolled in the GH-1941 Study [Follow-up Survey]
Brief Summary This study is conducted in Japan. The aim of the study is to evaluate the efficacy of somatropin (Norditropin®) on adult height (cm) in patients with achondroplasia / hypochondroplasia enrolled in the GH-1941 study (NCT01516229).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients enrolled in the GH-1941 study (NCT01516229) expected to achieve the adult height by 2015 and available for follow-up by the investigator
Condition
  • Genetic Disorder
  • Achondroplasia
Intervention Drug: somatropin
Dosage and administration to be prescribed by the physician as a result of a normal clinical practice.
Study Groups/Cohorts Norditropin®
Intervention: Drug: somatropin
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 Completed
Actual Enrollment
 (submitted: November 24, 2016)
81
Original Estimated Enrollment
 (submitted: September 15, 2011)
300
Actual Study Completion Date December 4, 2015
Actual Primary Completion Date December 4, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients who were enrolled in the GH-1941 study (1997 to 2006) and expected to theoretically reach the adult height within the study period
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01435629
Other Study ID Numbers GH-3907
U1111-1121-7729 ( Other Identifier: WHO )
JapicCTI-111622 ( Other Identifier: JAPIC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor Novo Nordisk A/S
Collaborators Not Provided
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date May 2017