The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease (LDN-Ped)
|
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: NCT00715117 |
|
Recruitment Status :
Completed
First Posted : July 15, 2008
Results First Posted : May 30, 2013
Last Update Posted : September 6, 2018
|
Sponsor:
Milton S. Hershey Medical Center
Information provided by (Responsible Party):
Milton S. Hershey Medical Center
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Crohn's Disease |
| Interventions |
Drug: Naltrexone Other: Placebo, sugar pill |
| Enrollment | 14 |
Participant Flow
| Recruitment Details | 14 subjects were enrolled in this pilot trial and 2 were screen failures and not randomized or treated |
| Pre-assignment Details | The 2 subjects who were screen failures had PCDAI scores less than 30. |
| Arm/Group Title | A: Placebo Then Naltrexone | B: Naltrexone Then Naltrexone |
|---|---|---|
 Arm/Group Description |
Subjects will receive placebo for for the first 8weeks then be crossed over to active drug naltrexone for the last 8 weeks | Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 8 weeks followed by the same treatment for an additional 8 weeks |
| Period Title: Overall Study | ||
| Started | 6 | 6 |
| Completion fo 8 Week Study | 6 | 6 |
| Completed | 6 | 5 [1] |
| Not Completed | 0 | 1 |
| Reason Not Completed | ||
| Crohn's flare and rescue with steroids | 0 | 1 |
|
[1]
One subject flared and was rescued with steroids
|
||
Baseline Characteristics
| Arm/Group Title | A: Placebo Control Group | B: Naltrexone, Active Drug Group | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
Subjects will receive placebo for for the first 8weeks then be crossed over to active drug for the last 8 weeks | Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 16 weeks | Total of all reporting groups | |
| Overall Number of Baseline Participants | 6 | 6 | 12 | |
|
Baseline Analysis Population Description |
[Not Specified]
|
|||
|
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 6 participants | 6 participants | 12 participants | |
| <=18 years |
6 100.0%
|
6 100.0%
|
12 100.0%
|
|
| Between 18 and 65 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
| >=65 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
| Number Analyzed | 6 participants | 6 participants | 12 participants | |
| 12.2 (3.31) | 13 (3.22) | 12.5 (3.2) | ||
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 6 participants | 6 participants | 12 participants | |
| Female |
2 33.3%
|
5 83.3%
|
7 58.3%
|
|
| Male |
4 66.7%
|
1 16.7%
|
5 41.7%
|
|
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 6 participants | 6 participants | 12 participants | |
| Female |
2 33.3%
|
5 83.3%
|
7 58.3%
|
|
| Male |
4 66.7%
|
1 16.7%
|
5 41.7%
|
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||||
| United States | Number Analyzed | 6 participants | 6 participants | 12 participants |
| 6 | 6 | 12 | ||
|
Pediatric Crohn's Disease Activity Index (PCDAI) score
[1] Mean (Full Range) Unit of measure: Score |
||||
| Number Analyzed | 6 participants | 6 participants | 12 participants | |
|
45
(35 to 52.5)
|
38.3
(30 to 57)
|
41.7
(30 to 57)
|
||
|
[1]
Measure Description: The PCDAI score is a number unit that is calculated from symptoms scores by the subject over a 7-day period prior to the visit, laboratory values, height & weight, and physical exam findings. A score of 10 and under denotes "remission". Mild disease (score of 11-30); moderate disease (score of 31-45), a severe disease (scores greater than 45. A decline of 10 points or more is considered "response to therapy". The score can range from 0 to >60 Patient must have a PCDAI score of equal or greater than 30 to qualify for this study (i.e., moderate to severe disease).
|
||||
Outcome Measures
Adverse Events
Limitations and Caveats
This was a pseudo-crossover trial where 6 subjects received placebo for 8 wks then were crossed over to active drug for 8 wks to increase the N treated with active drug. A smaller cohort of subjects on placebo were for safety & toxicity comparison.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
No restrictions by the sponsor. The PI may disclose results after the manuscript has been published.
Results Point of Contact
| Name/Title: | Jill P Smith, MD Professor Emeritus of medicine |
| Organization: | Pennsylvania State University |
| Phone: | 717-531-3694 |
| EMail: | jsmith2@psu.edu |
Other Publications:
| Responsible Party: | Milton S. Hershey Medical Center |
| ClinicalTrials.gov Identifier: | NCT00715117 |
| Other Study ID Numbers: |
PSU-IRB-27793 |
| First Submitted: | July 14, 2008 |
| First Posted: | July 15, 2008 |
| Results First Submitted: | August 4, 2011 |
| Results First Posted: | May 30, 2013 |
| Last Update Posted: | September 6, 2018 |