Trial Outcomes & Findings for Lanreotide in the Treatment of Small Bowel Motility Disorders (NCT NCT03012594)
NCT ID: NCT03012594
Last Updated: 2021-01-15
Results Overview
If the small bowel transit time, as measured by wireless capsule endoscopy, is decreased to \< 6hrs, then patient would be considered a responder and that lanreotide is efficacious.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
3 months
Results posted on
2021-01-15
Participant Flow
First subject was enrolled on 5/11/2017 and the last subject was enrolled on 7/19/2018. All study visits were performed either at a medical clinic or gastroenterology unit. There were also phone follow-ups.
This is an open label non-randomized study. All enrolled participants were checked to see if they meet all the screening requirements to participate. All willing and qualified participants received the study mediation.
Participant milestones
| Measure |
Lanreotide
Open label
Lanreotide: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lanreotide in the Treatment of Small Bowel Motility Disorders
Baseline characteristics by cohort
| Measure |
Lanreotide
n=9 Participants
Open label
Lanreotide: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart
|
|---|---|
|
Age, Continuous
|
46.78 years
STANDARD_DEVIATION 13.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
|
BMI
|
27.11 kg/m^2
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Heart rate
|
70.67 beats/sec
STANDARD_DEVIATION 10.91 • n=5 Participants
|
|
Systolic Blood pressure
|
120 mmHg
STANDARD_DEVIATION 19 • n=5 Participants
|
|
Diastolic blood pressure
|
77 mmHg
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Blood Glucose
|
118 mg/dL
STANDARD_DEVIATION 75 • n=5 Participants
|
|
Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index_Heartburn/regurgitation
|
1.73 units on a scale
STANDARD_DEVIATION 1.85 • n=5 Participants
|
|
Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index_Nausea/vomiting
|
1.85 units on a scale
STANDARD_DEVIATION 2.07 • n=5 Participants
|
|
Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index_Fullness/early satiety
|
3.22 units on a scale
STANDARD_DEVIATION 1.84 • n=5 Participants
|
|
Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index_Bloating
|
3.67 units on a scale
STANDARD_DEVIATION 1.57 • n=5 Participants
|
|
Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index_Upper abdominal pain
|
2.5 units on a scale
STANDARD_DEVIATION 1.86 • n=5 Participants
|
|
Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index_Lower abdominal pain
|
2.83 units on a scale
STANDARD_DEVIATION 1.62 • n=5 Participants
|
|
Gastric emptying time
|
323 minutes
STANDARD_DEVIATION 232 • n=5 Participants
|
|
Small bowel transit time
|
505 minutes
STANDARD_DEVIATION 159 • n=5 Participants
|
|
Colonic transit time
|
2503 minutes
STANDARD_DEVIATION 1592 • n=5 Participants
|
|
Small bowel and colonic transit time
|
2835 minutes
STANDARD_DEVIATION 1556 • n=5 Participants
|
|
Whole gut transit time
|
3160 minutes
STANDARD_DEVIATION 1533 • n=5 Participants
|
|
Stomach Contractions
|
2.06 Contractions/min
STANDARD_DEVIATION 1.02 • n=5 Participants
|
|
Stomach Mean Pressure
|
4.44 mm Hg
STANDARD_DEVIATION 3.31 • n=5 Participants
|
|
Stomach High Pressure
|
313.82 mmHg
STANDARD_DEVIATION 53.86 • n=5 Participants
|
|
Stomach Low pH
|
0 pH
STANDARD_DEVIATION 3.84 • n=5 Participants
|
|
Stomach Median pH
|
2.21 pH
STANDARD_DEVIATION 1.21 • n=5 Participants
|
|
Stomach High pH
|
7.48 pH
STANDARD_DEVIATION 3.22 • n=5 Participants
|
|
Gastric Antrum Motility Index
|
17.68 index
STANDARD_DEVIATION 22.7 • n=5 Participants
|
|
Antrum Contractions
|
2.4 Contractions/min
STANDARD_DEVIATION 2.09 • n=5 Participants
|
|
Antrum Mean Pressure
|
4.89 mmHg
STANDARD_DEVIATION 3.88 • n=5 Participants
|
|
Antrum High Pressure
|
271.94 mmHg
STANDARD_DEVIATION 104.4 • n=5 Participants
|
|
Antrum Low pH
|
0.76 pH
STANDARD_DEVIATION 0.49 • n=5 Participants
|
|
Antrum Median pH
|
1.13 pH
STANDARD_DEVIATION 0.87 • n=5 Participants
|
|
Antrum High pH
|
4.67 pH
STANDARD_DEVIATION 1.81 • n=5 Participants
|
|
Duodenum Motility Index
|
16.84 index
STANDARD_DEVIATION 22.36 • n=5 Participants
|
|
Duodenum Contractions
|
3.13 Contractions/min
STANDARD_DEVIATION 2.99 • n=5 Participants
|
|
Duodenum Mean Pressure
|
3.52 mmHg
STANDARD_DEVIATION 1.85 • n=5 Participants
|
|
Duodenum High Pressure
|
87.07 mmHg
STANDARD_DEVIATION 59.38 • n=5 Participants
|
|
Duodenum Low pH
|
2.33 pH
STANDARD_DEVIATION 1.83 • n=5 Participants
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|
Duodenum Median pH
|
6.30 pH
STANDARD_DEVIATION 0.64 • n=5 Participants
|
|
Duodenum High pH
|
7.07 pH
STANDARD_DEVIATION 0.60 • n=5 Participants
|
|
Small Bowel Contractions
|
3.88 Contractions/min
STANDARD_DEVIATION 2.05 • n=5 Participants
|
|
Small Bowel Mean Pressure
|
4.03 mmHg
STANDARD_DEVIATION 1.71 • n=5 Participants
|
|
Small Bowel High Pressure
|
143.67 mmHg
STANDARD_DEVIATION 88.35 • n=5 Participants
|
|
Small Bowel Low pH
|
2.32 pH
STANDARD_DEVIATION 1.87 • n=5 Participants
|
|
Small Bowel Median pH
|
7.36 pH
STANDARD_DEVIATION 0.15 • n=5 Participants
|
|
Small Bowel High pH
|
7.89 pH
STANDARD_DEVIATION 0.30 • n=5 Participants
|
|
Colon Contractions
|
2.10 Contractions/min
STANDARD_DEVIATION 0.78 • n=5 Participants
|
|
Colon Mean Pressure
|
4.29 mmHg
STANDARD_DEVIATION 1.21 • n=5 Participants
|
|
Colon High Pressure
|
177.84 mmHg
STANDARD_DEVIATION 108.54 • n=5 Participants
|
|
Colon Low pH
|
5.19 pH
STANDARD_DEVIATION 0.37 • n=5 Participants
|
|
Colon Median pH
|
6.44 pH
STANDARD_DEVIATION 0.41 • n=5 Participants
|
|
Colon High pH
|
8.41 pH
STANDARD_DEVIATION 0.38 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsIf the small bowel transit time, as measured by wireless capsule endoscopy, is decreased to \< 6hrs, then patient would be considered a responder and that lanreotide is efficacious.
Outcome measures
| Measure |
Lanreotide
n=9 Participants
Open label
Lanreotide: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart
|
|---|---|
|
Effect of Lanreotide on Gastrointestinal Motility as Measured by Smart Pill
Gastric emptying time
|
371.52 minutes
Standard Error 45.18
|
|
Effect of Lanreotide on Gastrointestinal Motility as Measured by Smart Pill
Small bowel transit time
|
392 minutes
Standard Error 47.51
|
|
Effect of Lanreotide on Gastrointestinal Motility as Measured by Smart Pill
Colonic transit time
|
4767 minutes
Standard Error 1286
|
|
Effect of Lanreotide on Gastrointestinal Motility as Measured by Smart Pill
Small bowel and Colonic transit time
|
5159 minutes
Standard Error 1284
|
|
Effect of Lanreotide on Gastrointestinal Motility as Measured by Smart Pill
Whole gut transit time
|
5530 minutes
Standard Error 1322
|
SECONDARY outcome
Timeframe: 3 monthsImprovement in symptoms assessed by improvement in Patient Assessment of Gastrointestinal Disorders Symptom Severity Index(PAGI-SYM) scores. If the PAGI-Sym scores were decreased by at least 0.7 points at 3 months when compared to baseline/pre treatment, then it will be considered that Lanreotide has significantly improved the symptom severity. Higher values represent worse symptoms. The participant rated each of the measured gastrointestinal symptom severity as described 0=No symptom, 1=Very Mild Symptom, 2= Mild Symptoms, 3= Moderate symptom, 4=Severe symptom, 5= Very Severe symptom. PAGI-SYM is a brief (20-items with 6 sub scales) symptom severity questionnaire that captures information on common upper gastrointestinal symptoms which include including Heartburn/regurgitation, Nausea/vomiting, Fullness/early satiety, bloating, Upper abdominal pain, and Lower abdominal pain. The presented data is an average of each sub scale.
Outcome measures
| Measure |
Lanreotide
n=9 Participants
Open label
Lanreotide: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart
|
|---|---|
|
Improvement in Symptoms as Accessed by "Patient Assessment of Upper GastroIntestinal Symptom Severity Index"
Heartburn/regurgitation
|
1.48 score on a scale
Standard Error 0.27
|
|
Improvement in Symptoms as Accessed by "Patient Assessment of Upper GastroIntestinal Symptom Severity Index"
Nausea/vomiting
|
1.00 score on a scale
Standard Error 0.35
|
|
Improvement in Symptoms as Accessed by "Patient Assessment of Upper GastroIntestinal Symptom Severity Index"
Fullness/early satiety
|
2.36 score on a scale
Standard Error 0.4
|
|
Improvement in Symptoms as Accessed by "Patient Assessment of Upper GastroIntestinal Symptom Severity Index"
Bloating
|
2.43 score on a scale
Standard Error 0.47
|
|
Improvement in Symptoms as Accessed by "Patient Assessment of Upper GastroIntestinal Symptom Severity Index"
Upper abdominal pain
|
2.14 score on a scale
Standard Error 0.62
|
|
Improvement in Symptoms as Accessed by "Patient Assessment of Upper GastroIntestinal Symptom Severity Index"
Lower abdominal pain
|
2.00 score on a scale
Standard Error 0.51
|
Adverse Events
Lanreotide
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lanreotide
n=9 participants at risk
Open label
Lanreotide: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart
|
|---|---|
|
Investigations
Difficulty swallowing wireless motility capsule pill
|
11.1%
1/9 • Number of events 9 • 1 month after last dose, up to 4 months from the start for each subject.
|
|
Investigations
Unable to acknowledge the passage of the wireless motility capsule through the feces
|
11.1%
1/9 • Number of events 9 • 1 month after last dose, up to 4 months from the start for each subject.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place