Trial · Interventional

TerminatedPhase 2/3Results postedRegistry data

Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease

NCTNCT00511329Other idGA628132

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: PI left the institution

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2/3
Enrollment: 10 participants (actual)
Sponsor: Nationwide Children's Hospital · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Aug 2007
Primary completion: May 2010
Completion: May 2010
First posted: 3 Aug 2007 (estimated)
Last update posted: 12 Apr 2018
Conditions: Arthritis, Juvenile Rheumatoid · Crohn Disease

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20072008200920102011

Ph 2/3
Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease
NCT00511329
Aug 2007 to May 2010
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The investigators hypothesize that the anabolic effects of Genotropin (somatropin) will improve the height and weight of children with inflammatory based chronic illness who have failed to grow despite receiving adequate nutrition. The investigators will test the hypothesis by treating 32 chronically ill children (16 JRA and 16 Crohn's) with growth hormone (GH) for 12 months and comparing them to baseline.

Interventions

somatropin [rDNA origin] for injectionDrug

Arms1

Experimental
Somatropin

Primary outcomes1

Outcomes the sponsor listed as primary.

The Primary Outcome Variables Will be Height and Weight Z Score.
Time frame · 12 months

Secondary outcomes(1)

Secondary Outcome Variables Will Include Change in Lean Body Mass, Change in Bone Mineral Content, Change in Inflammatory Mediated Cytokine Levels and Change in Bone Turnover.
Time frame · 12 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· 12 months

The Primary Outcome Variables Will be Height and Weight Z Score.

Group	Value
Somatropin	not posted

Secondary and other outcome results(1)

Secondary outcome· 12 months

Secondary Outcome Variables Will Include Change in Lean Body Mass, Change in Bone Mineral Content, Change in Inflammatory Mediated Cytokine Levels and Change in Bone Turnover.

Group	Value
Somatropin	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Somatropinsomatropin \[rDNA origin\] for injection: Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages.	–	0 / 0	0 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2006

Growth hormone treatment improves growth and clinical status in prepubertal children with cystic fibrosis: results of a multicenter randomized controlled trial.

Hardin et al. 2006The Journal of clinical endocrinology and metabolismcited by 41

PMID 17018651DOI 10.1210/jc.2006-1101PUB-17018651

Rights unknown

Source link

Eligibility

Who could join, as posted.

Sex: All
Age: from 5 Years up to 17 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Referral for continued poor growth (growth velocity less than the 25th percentile) 2. Height less than the 10th percentile 3. Weight less than the 10th percentile compared to age and gender- matched normal values. Exclusion Criteria: 1. Previous diagnosis with diabetes, chronic fevers (temp \> 101.5) or chronic bacterial infection 2. Previous treatment with GH 3. Bone age \> 17

PepBank is a research reference. Talk to a doctor before you use any peptide.