Trial Outcomes & Findings for The Effects of Naltrexone on Active Crohn's Disease (NCT NCT00663117)
NCT ID: NCT00663117
Last Updated: 2018-10-02
Results Overview
The CDAI score is a number which consists of information collected from a 7-day diary from the patient regarding symptoms. It also includes objective information from the physical exam, weight and hemotocrit. Remission is considered a score of 150 or less. Active disease is considered 220 or greater. A response to therapy is considered a decline in the CDAI score of 70-points from baseline.
COMPLETED
PHASE2
40 participants
3 months
2018-10-02
Participant Flow
This prospective, double blind, randomized placebo-controlled trial, undertaken between September 2006 and September 2009 at the Pennsylvania State University College of Medicine.
Participant milestones
| Measure |
Placebo Then Naltrexone 4.5 mg Daily
Subjects will receive placebo for 3 months then be crossed over to active drug for an additional 3 months
|
Naltrexone Then Naltrexone 4.5 mg po Daily
Group 2 will receive naltrexone 4.5 mg by mouth once a day for 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo Then Naltrexone 4.5 mg Daily
Subjects will receive placebo for 3 months then be crossed over to active drug for an additional 3 months
|
Naltrexone Then Naltrexone 4.5 mg po Daily
Group 2 will receive naltrexone 4.5 mg by mouth once a day for 6 months
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
Baseline Characteristics
The Effects of Naltrexone on Active Crohn's Disease
Baseline characteristics by cohort
| Measure |
Placebo Daily
n=20 Participants
Subjects will receive placebo for 3 months then be crossed over to active drug for an additional 3 months
|
Naltrexone 4.5 mg po Daily
n=20 Participants
Group 2 will receive naltrexone 4.5 mg by mouth once a day for 6 months
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
44.8 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
40.5 years
STANDARD_DEVIATION 2.4 • n=7 Participants
|
42.3 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Crohn's Disease Activity Index (CDAI) score
|
327 CDAI score
STANDARD_DEVIATION 19 • n=5 Participants
|
365 CDAI score
STANDARD_DEVIATION 16 • n=7 Participants
|
346 CDAI score
STANDARD_DEVIATION 17.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThe CDAI score is a number which consists of information collected from a 7-day diary from the patient regarding symptoms. It also includes objective information from the physical exam, weight and hemotocrit. Remission is considered a score of 150 or less. Active disease is considered 220 or greater. A response to therapy is considered a decline in the CDAI score of 70-points from baseline.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo treated subjects for 12 weeks were analyzed for the percentage that achieved the primary outcome of a 70-point decline in the CDAI score from Baseline values
|
Naltrexone 4.5 mg po Daily
n=20 Participants
Naltrexone treated subjects for 12 weeks were analyzed for the percentage that achieved the primary outcome of a 70-point decline in the CDAI score from Baseline values
|
|---|---|---|
|
Percentage of Subjects Achieving a 70-point Decline in CDAI Scores (Crohn's Disease Activity Index) Scores;
|
40 percentage of pts
|
88 percentage of pts
|
SECONDARY outcome
Timeframe: Between baseline and 3 monthsPopulation: Same as sample size calculation
IBDQ (Inflammatory bowel Disease questionnaire) contains questions about health ranging from a score of poor (i.e., 32) to excellent (i.e., 224) an increase from baseline indicates improvement in quality of life.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo treated subjects for 12 weeks were analyzed for the percentage that achieved the primary outcome of a 70-point decline in the CDAI score from Baseline values
|
Naltrexone 4.5 mg po Daily
n=20 Participants
Naltrexone treated subjects for 12 weeks were analyzed for the percentage that achieved the primary outcome of a 70-point decline in the CDAI score from Baseline values
|
|---|---|---|
|
Percentage Change From Baseline of Quality of Life IBDQ (Inflammatory Bowel Disease Quality of Life Survey)
|
18 percentage of change
Standard Error 4
|
28 percentage of change
Standard Error 5
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Sample size was calculated under the assumption that at least 60% of the naltrexone-treated patients, and no more than 10% of the placebo-treated patients, would respond with at least a 70-point decline in CDAI scores. With a 10% withdrawal rate, 40 subjects yields an 86% power using a two-sided, 0.05-significance level Fisher's exact test.
A secondary outcome was the appearance of the colonic mucosa on endoscopy using the Crohn's Disease Endoscopic Index of Severity (CDEIS) score described by Mary et al. Gut 1989;30:983-989.This score ranges from 0-44 based upon the extent and severity of inflammation and ulcers seen during endoscopy of the colon. A response is a drop of \> 5 points from baseline. Endoscopic remission is a score of \< 6 and Complete endoscopic remission is a score of \> 3.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo treated subjects for 12 weeks were analyzed for the percentage that achieved the primary outcome of a 70-point decline in the CDAI score from Baseline values
|
Naltrexone 4.5 mg po Daily
n=20 Participants
Naltrexone treated subjects for 12 weeks were analyzed for the percentage that achieved the primary outcome of a 70-point decline in the CDAI score from Baseline values
|
|---|---|---|
|
Percentage of Patients With a 5 Point Drop in CDEIS Score by Endoscopy
|
28 percentage of patients
Interval 0.0 to 100.0
|
78 percentage of patients
.05 • Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Tissue was removed by biopsy in those undergoing colonoscopy
Histology scores to assess microscopic inflammation and structural architecture were determined at baseline and after 12 weeks of either naltrexone therapy or placebo by mucosal biopsy samples obtained during colonoscopies.The pathology specimens were reviewed and scored by a Pathologist blinded to the treatment. The mean scores at baseline were the same between both groups.Differences between naltrexone and placebo treated subjects was assessed.The range in scores could be 0-25, with 0 representing no inflammation and 25 being maximum or severe inflammation..
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo treated subjects for 12 weeks were analyzed for the percentage that achieved the primary outcome of a 70-point decline in the CDAI score from Baseline values
|
Naltrexone 4.5 mg po Daily
n=20 Participants
Naltrexone treated subjects for 12 weeks were analyzed for the percentage that achieved the primary outcome of a 70-point decline in the CDAI score from Baseline values
|
|---|---|---|
|
Histology Inflammatory Score by Colon Biopsies
|
17.5 units on a scale
Standard Error 4.5
|
5.2 units on a scale
Standard Error 2.3
|
Adverse Events
Placebo
Naltrexone 4.5 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=20 participants at risk
Participants who received placebo for the first 12 weeks.
|
Naltrexone 4.5 mg
n=40 participants at risk
All participants who received naltrexone either for 12 or 24 weeks.
|
|---|---|---|
|
Nervous system disorders
insomnia
|
25.0%
5/20 • Number of events 5
|
12.5%
5/40 • Number of events 5
|
|
General disorders
Fatigue
|
15.0%
3/20 • Number of events 3
|
0.00%
0/40
|
Additional Information
Jill P Smith, MD Professor of Medicine, Gastroenterology Division
Pennsylvania State University, College of Medicine Hershey, PA 17033
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place