Trial Outcomes & Findings for Nortriptyline for Idiopathic Gastroparesis (NCT NCT00765895)
NCT ID: NCT00765895
Last Updated: 2020-05-14
Results Overview
A decrease from the baseline Gastroparesis Cardinal Symptom Index (GCSI) score (sum of the 9 individual symptom scores) of at least 50% on any two consecutive follow-up visits during the 15 week treatment period with maximum tolerated study drug dose. The total score ranges from 0-45 with higher scores indicating greater symptom severity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
130 participants
Primary outcome timeframe
at end of treatment, 15 weeks from baseline assessment
Results posted on
2020-05-14
Participant Flow
Participant milestones
| Measure |
Nortriptyline
Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg
Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week
|
Placebo
No treatment
Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
65
|
|
Overall Study
COMPLETED
|
65
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nortriptyline for Idiopathic Gastroparesis
Baseline characteristics by cohort
| Measure |
Nortriptyline
n=65 Participants
Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg
Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week
|
Placebo
n=65 Participants
No treatment
Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 12 • n=99 Participants
|
40 years
STANDARD_DEVIATION 12 • n=107 Participants
|
41 years
STANDARD_DEVIATION 12 • n=206 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
116 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
115 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=99 Participants
|
65 participants
n=107 Participants
|
130 participants
n=206 Participants
|
|
Body mass index
|
27 kg/m^2
STANDARD_DEVIATION 5 • n=99 Participants
|
28 kg/m^2
STANDARD_DEVIATION 7 • n=107 Participants
|
27 kg/m^2
STANDARD_DEVIATION 6 • n=206 Participants
|
|
proton-pump inhibitor taken in last month
|
48 participants
n=99 Participants
|
49 participants
n=107 Participants
|
97 participants
n=206 Participants
|
|
benzodiazepine taken in last month
|
26 participants
n=99 Participants
|
14 participants
n=107 Participants
|
40 participants
n=206 Participants
|
|
prokinetic taken in last month
|
23 participants
n=99 Participants
|
25 participants
n=107 Participants
|
48 participants
n=206 Participants
|
|
antiemetics taken in last month
|
39 participants
n=99 Participants
|
33 participants
n=107 Participants
|
72 participants
n=206 Participants
|
|
selective serotonin reuptake inhibitor taken in last month
|
7 participants
n=99 Participants
|
11 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
GSCI total score
|
30.9 units on a scale
STANDARD_DEVIATION 6.1 • n=99 Participants
|
30.3 units on a scale
STANDARD_DEVIATION 6.5 • n=107 Participants
|
30.6 units on a scale
STANDARD_DEVIATION 6.3 • n=206 Participants
|
|
GSCI- nausea sub score
|
8.2 units on a scale
STANDARD_DEVIATION 3.6 • n=99 Participants
|
8.2 units on a scale
STANDARD_DEVIATION 4.2 • n=107 Participants
|
8.2 units on a scale
STANDARD_DEVIATION 3.9 • n=206 Participants
|
|
GSCI- satiety sub score
|
15.4 units on a scale
STANDARD_DEVIATION 3.4 • n=99 Participants
|
15.1 units on a scale
STANDARD_DEVIATION 4.1 • n=107 Participants
|
15.3 units on a scale
STANDARD_DEVIATION 3.7 • n=206 Participants
|
|
GSCI- bloating sub score
|
7.2 units on a scale
STANDARD_DEVIATION 2.9 • n=99 Participants
|
7.0 units on a scale
STANDARD_DEVIATION 2.7 • n=107 Participants
|
7.1 units on a scale
STANDARD_DEVIATION 2.8 • n=206 Participants
|
|
PAGI-SYM- upper abdominal pain sub score
|
6.8 units on a scale
STANDARD_DEVIATION 2.9 • n=99 Participants
|
6.5 units on a scale
STANDARD_DEVIATION 2.9 • n=107 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 2.9 • n=206 Participants
|
|
PAGI-SYM- lower abdominal pain sub score
|
4.7 units on a scale
STANDARD_DEVIATION 3.3 • n=99 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 3.3 • n=107 Participants
|
4.5 units on a scale
STANDARD_DEVIATION 3.3 • n=206 Participants
|
|
PAGI-SYM- GERD sub score
|
15.4 units on a scale
STANDARD_DEVIATION 9.4 • n=99 Participants
|
17.9 units on a scale
STANDARD_DEVIATION 10.5 • n=107 Participants
|
16.7 units on a scale
STANDARD_DEVIATION 10.7 • n=206 Participants
|
|
GI symptoms constipation sub score
|
2.8 units on a scale
STANDARD_DEVIATION 1.9 • n=99 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 1.7 • n=107 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 1.8 • n=206 Participants
|
|
GI symptom diarrhea sub score
|
1.8 units on a scale
STANDARD_DEVIATION 1.7 • n=99 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 1.8 • n=107 Participants
|
1.9 units on a scale
STANDARD_DEVIATION 1.8 • n=206 Participants
|
|
PAGI-SYM nausea/vomiting predominant symptom
|
27 participants
n=99 Participants
|
22 participants
n=107 Participants
|
49 participants
n=206 Participants
|
|
clinical global patient impression score
|
-0.7 units on a scale
STANDARD_DEVIATION 0.9 • n=99 Participants
|
-0.7 units on a scale
STANDARD_DEVIATION 1.2 • n=107 Participants
|
-0.7 units on a scale
STANDARD_DEVIATION 1.0 • n=206 Participants
|
|
Gastroparesis Symptom Rating Scale score
|
3.6 units on a scale
STANDARD_DEVIATION 1.1 • n=99 Participants
|
3.7 units on a scale
STANDARD_DEVIATION 1.2 • n=107 Participants
|
3.6 units on a scale
STANDARD_DEVIATION 1.2 • n=206 Participants
|
|
SF-36 Quality of Life - Physical component
|
35 units on a scale
STANDARD_DEVIATION 10 • n=99 Participants
|
36 units on a scale
STANDARD_DEVIATION 10 • n=107 Participants
|
35 units on a scale
STANDARD_DEVIATION 10 • n=206 Participants
|
|
SF-36 Quality of Life -Mental component
|
41 units on a scale
STANDARD_DEVIATION 13 • n=99 Participants
|
40 units on a scale
STANDARD_DEVIATION 13 • n=107 Participants
|
40 units on a scale
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Beck Depression Inventory- total score
|
17 units on a scale
STANDARD_DEVIATION 11 • n=99 Participants
|
18 units on a scale
STANDARD_DEVIATION 12 • n=107 Participants
|
17 units on a scale
STANDARD_DEVIATION 12 • n=206 Participants
|
|
Beck Depression Inventory- severe depression score
|
12 participants
n=99 Participants
|
15 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
Brief Pain Inventory- severity score
|
4.0 units on a scale
STANDARD_DEVIATION 2.5 • n=99 Participants
|
4.1 units on a scale
STANDARD_DEVIATION 2.7 • n=107 Participants
|
4.0 units on a scale
STANDARD_DEVIATION 2.6 • n=206 Participants
|
|
Brief Pain Inventory- interference score
|
4.2 units on a scale
STANDARD_DEVIATION 3.0 • n=99 Participants
|
4.1 units on a scale
STANDARD_DEVIATION 3.3 • n=107 Participants
|
4.1 units on a scale
STANDARD_DEVIATION 3.1 • n=206 Participants
|
|
State Trait Anxiety Inventory- State Anxiety score
|
42 units on a scale
STANDARD_DEVIATION 13 • n=99 Participants
|
41 units on a scale
STANDARD_DEVIATION 12 • n=107 Participants
|
42 units on a scale
STANDARD_DEVIATION 12 • n=206 Participants
|
|
State Trait Anxiety Inventory- Trait Anxiety score
|
43 units on a scale
STANDARD_DEVIATION 12 • n=99 Participants
|
43 units on a scale
STANDARD_DEVIATION 13 • n=107 Participants
|
43 units on a scale
STANDARD_DEVIATION 12 • n=206 Participants
|
|
Patient Health Questionnaire-15
|
14 units on a scale
STANDARD_DEVIATION 5 • n=99 Participants
|
14 units on a scale
STANDARD_DEVIATION 5 • n=107 Participants
|
14 units on a scale
STANDARD_DEVIATION 5 • n=206 Participants
|
PRIMARY outcome
Timeframe: at end of treatment, 15 weeks from baseline assessmentPopulation: intention to treat
A decrease from the baseline Gastroparesis Cardinal Symptom Index (GCSI) score (sum of the 9 individual symptom scores) of at least 50% on any two consecutive follow-up visits during the 15 week treatment period with maximum tolerated study drug dose. The total score ranges from 0-45 with higher scores indicating greater symptom severity.
Outcome measures
| Measure |
Nortriptyline
n=65 Participants
Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg
Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week
|
Placebo
n=65 Participants
No treatment
Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week
|
|---|---|---|
|
Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits
|
15 participants
Interval 13.5 to 35.2
|
14 participants
Interval 12.3 to 33.5
|
Adverse Events
Nortriptyline
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nortriptyline
n=65 participants at risk
Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg
Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week
|
Placebo
n=65 participants at risk
No treatment
Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week
|
|---|---|---|
|
General disorders
allergic reaction
|
1.5%
1/65 • Number of events 1 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
0.00%
0/65 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
|
Gastrointestinal disorders
vomiting
|
3.1%
2/65 • Number of events 2 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
0.00%
0/65 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
|
Gastrointestinal disorders
Nausea and vomiting
|
1.5%
1/65 • Number of events 1 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
0.00%
0/65 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
|
Cardiac disorders
cardiac event
|
1.5%
1/65 • Number of events 1 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
0.00%
0/65 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/65 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
1.5%
1/65 • Number of events 1 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
Other adverse events
| Measure |
Nortriptyline
n=65 participants at risk
Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg
Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week
|
Placebo
n=65 participants at risk
No treatment
Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week
|
|---|---|---|
|
Nervous system disorders
Nervous system
|
6.2%
4/65 • Number of events 5 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
3.1%
2/65 • Number of events 2 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
|
Gastrointestinal disorders
gastrointestinal events
|
4.6%
3/65 • Number of events 5 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
7.7%
5/65 • Number of events 6 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
|
Cardiac disorders
cardiac
|
7.7%
5/65 • Number of events 6 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
7.7%
5/65 • Number of events 5 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
|
Skin and subcutaneous tissue disorders
rash
|
1.5%
1/65 • Number of events 1 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
0.00%
0/65 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
|
Renal and urinary disorders
renal and urinary events
|
4.6%
3/65 • Number of events 3 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
0.00%
0/65 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
|
Eye disorders
ocular events
|
1.5%
1/65 • Number of events 1 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
0.00%
0/65 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
|
General disorders
swelling of hands and feet
|
1.5%
1/65 • Number of events 1 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
0.00%
0/65 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
|
Psychiatric disorders
psychiatric
|
0.00%
0/65 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
4.6%
3/65 • Number of events 5 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
|
Endocrine disorders
endocrine
|
0.00%
0/65 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
1.5%
1/65 • Number of events 1 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
|
Metabolism and nutrition disorders
weight gain/loss
|
0.00%
0/65 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
4.6%
3/65 • Number of events 3 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
|
General disorders
general disorders
|
0.00%
0/65 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
4.6%
3/65 • Number of events 3 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
|
General disorders
pain
|
0.00%
0/65 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
3.1%
2/65 • Number of events 2 • Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place