Primary outcomeNumber· Baseline and 12 weeks
Crohn's Disease Histologic Index of Severity (CDHIS)
| Group | Value (scores on a scale) |
|---|---|
| Growth Hormone Plus Corticosteroid (CTX) | 7 |
| Corticosteroid (CTX) | 8 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataTrial of Growth Hormone Therapy in Pediatric Crohn's Disease
NCTNCT00109473 (opens ClinicalTrials.gov in a new tab)Other idCCHMC IRB #: 04-12-06Other idIND # 71,344
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 22 participants (actual)
- Sponsor
- Children's Hospital Medical Center, Cincinnati · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Apr 2005
- Primary completion
- Jul 2009
- Completion
- Aug 2009
- First posted
- 29 Apr 2005 (estimated)
- Last update posted
- 30 Oct 2020
- Conditions
- Crohn's Disease
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200520062007200820092010
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to determine whether taking a growth hormone (GH) drug called somatropin causes the intestine of a person with Crohn's Disease (CD) to heal faster when compared to a person with Crohn's Disease that does not receive growth hormone drug.
Interventions
- growth hormoneDrug
- cortecosteroidDrug
Arms2
Experimental
Growth Hormone plus cortecosteroid
Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
Active comparator
Cortecosteroids alone
Cortecosteroid therapy as prescribed by the referring gastroenterologist
Primary outcomes1
Outcomes the sponsor listed as primary.
Crohn's Disease Histologic Index of Severity (CDHIS)
Time frame · Baseline and 12 weeks
Registry description
The CDHIS was developed and validated in order to determine the effect of therapies upon histologic disease activity in Crohn's Disease. It has been used to assess mucosal healing in response to infliximab and 6-MP/AZA.It contains eight items which reflect epithelial injury, mucosal inflammation, and the extent of involvement. Scores range from 0-16, with patients with moderate to severely active CD typically having scores of 6-12. It was computed by a GI pathologist. The higher the score indicates worsening of disease, the lowest score is 0 and highest possible is 16
Secondary outcomes(7)
Serum IGF-1 (Insulin-like Growth Factor 1)z Score
Time frame · Baseline, 12 weeks, 24 weeks
Registry description
Elevated serum IGF-1 levels have been implicated in the development of colorectal cancer, both in the general population and in patients with an excess of growth hormone production. The serum IGF-1 levels were monitored to maintain them in the physiologic range during growth hormone therapy to reduce the risk of tumorigenesis. The levels are reported as a z score, a statistical way of standardizing data. The standard deviation is the unit of measurement of the z-score. Each z score corresponds to a point in a normal distribution, describing how much a point deviates from a mean.
IMPACT III Score
Time frame · Baseline, 12 weeks, 24 weeks
Registry description
Health-related quality of life (QOL)was assessed using the IMPACT 111 questionnnaire. It is a self-administered 35 item questionnaire which typically takes 10-15 minutes to complete. Scores range from 0-350, with higher scores reflecting better perceived quality of life.
Pediatric Crohn's Disease Activity Index (PCDAI)
Time frame · Baseline, 12 and 24 weeks
Registry description
The PCDAI is a previously validated measure of clinical disease activity for children with CD. It contains three self-report items which reflect patient abdominal pain, diarrhea, and general well being; three laboratory values; height and weight velocity; and three physical examination parameters reflecting abdominal tenderness, perirectal disease, and extra-intestinal manifestations. Scores may range from 0-100. Remission is defined as 0-10, mild disease as 10-30, and moderate to severe disease as greater than 30.
Total Corticosteroid Use
Time frame · 12 weeks
Registry description
The total corticosteroid use over 12 weeks between groups, using the unpaired t test.
Crohn's Disease Endoscopic Index of Severity (CDEIS)
Time frame · Baseline and 12 weeks
Registry description
Measure of mucosal disease at baseline and week 12 obtained during colonoscopy. The CDEIS score generally ranges from 0-30. A higher score indicates more severe mucosal inflammation.
Height Velocity
Time frame · Baseline, week 12, 24 and 48
Registry description
Height velocity was computed every 12 weeks up to week 64 and then yearly during the Maintenance study. Since 40 to 80% of children with Crohn's disease have significant growth failure at diagnosis, height velocity is used to track for changes in height. It is calculated by measuring height at two points of time and then dividing the change by the amount of time.
Fecal Calprotectin
Time frame · At 24 and 64 weeks
Registry description
Fecal calprotectin is a previously validated stool marker of intestinal inflammation in Crohn's Disease.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline, 12 weeks, 24 weeks
Serum IGF-1 (Insulin-like Growth Factor 1)z Score
| Group | Value (Z score) | Spread |
|---|---|---|
| Growth Hormone Plus Corticosteroid (CTX) | -0.4 | 0.6 |
| Corticosteroid (CTX) | -0.7 | 0.3 |
Secondary outcomeMean· Baseline, 12 weeks, 24 weeks
IMPACT III Score
| Group | Value (Scores on a scale) |
|---|---|
| Growth Hormone Plus Corticosteroid (CTX) | 134 |
| Corticosteroid (CTX) | 132 |
Secondary outcomeMean· Baseline, 12 and 24 weeks
Pediatric Crohn's Disease Activity Index (PCDAI)
| Group | Value (Scores on a scale) |
|---|---|
| Growth Hormone Plus Corticosteroid (CTX) | 32 |
| Corticosteroid (CTX) | 33 |
Secondary outcomeMean· 12 weeks
Total Corticosteroid Use
| Group | Value (mg) | Spread |
|---|---|---|
| Growth Hormone Plus Cortecosteroid | 22 | 8 |
| Cortecosteroids Alone | 28 | 10 |
Secondary outcomeMean· Baseline and 12 weeks
Crohn's Disease Endoscopic Index of Severity (CDEIS)
| Group | Value (Scores on a scale) |
|---|---|
| Growth Hormone Plus Corticosteroid (CTX) | 9 |
| Corticosteroid (CTX) | 8 |
Secondary outcomeMean· Baseline, week 12, 24 and 48
Height Velocity
| Group | Value (cm/year) | Spread |
|---|---|---|
| Growth Hormone Plus Corticosteroid (CTX) | 5 | 1 |
| Corticosteroid (CTX) | 3 | 1 |
Secondary outcomeMean· At 24 and 64 weeks
Fecal Calprotectin
| Group | Value (micrograms per gram (microg/g)) |
|---|---|
| Growth Hormone Plus Corticosteroid (CTX) | 863 |
| Corticosteroid (CTX) | 904 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Growth Hormone Plus Corticosteroid (CTX)Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily) | – | 1 / 10 | 10 / 10 |
| Corticosteroid (CTX)Subjects took corticosteroid as recommended by their physician | – | 0 / 10 | 10 / 10 |
| Extension PhaseEligible subjects from both group A and group B continued on growth hormone in a 52 week extension phase | – | 2 / 17 | 17 / 17 |
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
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 5 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Ability to provide written informed consent
* Age ≥ 5 years.
* Diagnosis of Crohn's disease (CD) with ileo-colonic involvement as determined by standard clinical, radiological, and pathological criteria.
* Moderate to severely active CD as defined by a PCDAI (Pediatric Crohn's Disease Activity Index) ≥ 30.
* Currently taking Prednisone or Budesonide at starting dose (not tapering)
* May continue stable doses of AZA/6-MP, methotrexate, and/or mesalamine at entry.
* For the 52 week extension, baseline bone age ≤ 12 years for girls and ≤ 13 years for boys.
* For the 52 week extension phase, remission or mild Crohn's disease as determined by a PCDAI \< 30.
Exclusion Criteria:
* Acute critical illness
* Active neoplasia
* Diabetes mellitus
* History of intracranial lesion and/or neoplasia
* Severe disease requiring hospitalization for treatment
* Current therapy with infliximab as this may independently rapidly reduce clinical disease activity and promote mucosal healing
* Use of prednisone or budesonide and in tapering phase
* Family history of colorectal cancer before age 50
* Personal or familial history of familial polyposis syndrome
* Pregnancy (positive pregnancy test) prior to randomization
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Participation in another simultaneous medical investigation or trial other than the Pediatric IBD (Inflammatory Bowel Disease) registry
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