Trial Outcomes & Findings for Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease (NCT NCT00511329)

NCT ID: NCT00511329

Last Updated: 2018-04-12

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

10 participants

Primary outcome timeframe

12 months

Results posted on

2018-04-12

Participant Flow

PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.

Participant milestones

Participant milestones
Measure
Somatropin
somatropin \[rDNA origin\] 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.
Overall Study
STARTED
0
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 12 months

Population: PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.

Outcome measures

Outcome data not reported

Adverse Events

Somatropin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julie Rice, RN

Nationwide Children's Hospital

Phone: 6143553142

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place