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Trial record 2 of 4 for:    Somapacitan | Child

A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day

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ClinicalTrials.gov Identifier: NCT03878446
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe).

Participants will either get somapacitan or Norditropin® - which treatment is decided by chance. Both participants and the study doctor will know which treatment the participants get. The study will last for 4 years. Participants will take either an injection once every week or once every day. Participants will have 9 clinic visits and will be in the study for 1 year. The follow-up period is at least 30 days.


Condition or disease Intervention/treatment Phase
Short Stature Children Born Small for Gestational Age (SGA) Drug: somapacitan Drug: Norditropin® Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Dose-finding Trial Evaluating the Effect and Safety of Once-weekly Treatment of Somapacitan Compared to Daily Norditropin® in Children With Short Stature Born Small for Gestational Age With no Catch-up Growth by 2 Years of Age or Older
Actual Study Start Date : July 4, 2019
Estimated Primary Completion Date : June 8, 2020
Estimated Study Completion Date : April 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dwarfism

Arm Intervention/treatment
Experimental: 0.24 mg/kg somapacitan
Same treatment in main period (13 weeks) and extension period (39 weeks)
Drug: somapacitan
Somapacitan injected under the skin once a week for a total of 52 weeks

Experimental: 0.20 mg/kg somapacitan
Same treatment in main period (13 weeks) and extension period (39 weeks)
Drug: somapacitan
Somapacitan injected under the skin once a week for a total of 52 weeks

Experimental: 0.16 mg/kg somapacitan
Same treatment in main period (13 weeks) and extension period (39 weeks)
Drug: somapacitan
Somapacitan injected under the skin once a week for a total of 52 weeks

Active Comparator: 0.035 mg/kg Norditropin®
Same treatment in main period (13 weeks) and extension period (39 weeks)
Drug: Norditropin®
Norditropin® injected under the skin once a day for a total of 52 weeks

Active Comparator: 0.067 mg/kg Norditropin®
Same treatment in main period (13 weeks) and extension period (39 weeks)
Drug: Norditropin®
Norditropin® injected under the skin once a day for a total of 52 weeks




Primary Outcome Measures :
  1. Height velocity [ Time Frame: From baseline (week 0) to week 26 ]
    cm/year


Secondary Outcome Measures :
  1. Change in bone age [ Time Frame: From baseline (week 0) to week 52 ]
    years

  2. Change in height standard deviation score (SDS) [ Time Frame: From baseline (week 0) to week 26 ]
    -10 to +10

  3. Change in height velocity SDS [ Time Frame: From baseline (week 0) to week 26 ]
    -10 to +10

  4. Change in fasting plasma glucose [ Time Frame: From screening (visit 1) to week 26 ]
    mmol/l

  5. Change in homeostatic model assessment (HOMA) [ Time Frame: From screening (visit 1) to week 26 ]
    Percent

  6. Change in glycated haemoglobin (HbA1c) [ Time Frame: From screening (visit 1) to week 26 ]
    Percentage points

  7. Change in insulin-like growth factor I (IGF-I) SDS [ Time Frame: From screening (visit 1) to week 26 ]
    -10 to +10

  8. Change in insulin-like growth factor binding protein 3 (IGFBP-3) SDS [ Time Frame: From screening (visit 1) to week 26 ]
    -10 to +10



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pre-pubertal children, boys:

    1. age between 2.5 and 11.0 years at screening.
    2. testes volume below 4 ml.
  • Pre-pubertal children, girls:

    1. age between 2.5 and 10.0 years at screening.
    2. Tanner stage 1 for breast development (no palpable glandular breast tissue).
  • Born small for gestational age (birth length and/or weight below -2 standard deviation scores) (according to national standards).
  • Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and gender at screening according to the standards of Centers for Disease Control and Prevention at screening.
  • Impaired height velocity defined as annualised height velocity below the 50th percentile for chronological age and gender according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening.
  • No prior exposure to growth hormone therapy or Insulin-like Growth Factor-I (IGF-I) treatment.

Exclusion Criteria:

  • Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements.
  • Children with hormonal deficiencies including suspected or confirmed growth hormone deficiency according to local practise.
  • Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening.
  • Children requiring inhaled glucocorticoid therapy at a dose of greater than 400 μg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening.
  • Concomitant administration of other treatments that may have an effect on growth, e.g but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder.
  • Diagnosis of attention deficit hyperactivity disorder.
  • Prior history or presence of malignancy including intracranial tumours.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878446


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure 1452 Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03878446     History of Changes
Other Study ID Numbers: NN8640-4245
U1111-1207-9741 ( Other Identifier: World Health Organization (WHO) )
2018-000232-10 ( EudraCT Number )
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases