Effect of Lanreotide on Gastrointestinal Motility as Measured by Smart Pill
| Group | Value (minutes) | Spread |
|---|---|---|
| Lanreotide | 371.52 | 45.18 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a human research study looking at the effectiveness of Lanreotide (study medication) in treating small bowel motility disorders. It is similar to a natural hormone somatostatin that is produced in the body in the stomach, duodenum, pancreas and brain. Somatostatin is a growth hormone-inhibiting hormone. Lanreotide is a man made hormone and is a long acting medication that is given once a month. It is marketed with a trade name "Somatuline Depot". It is given deep subcutaneously (deep within the layers of the skin) in the superior external quadrant of the buttock. Injection site will be alternated on subsequent injections.
Experimental
Lanreotide
Open label
Outcomes the sponsor listed as primary.
Effect of Lanreotide on Gastrointestinal Motility as Measured by Smart Pill
Time frame · 3 months
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.
Improvement in Symptoms as Accessed by "Patient Assessment of Upper GastroIntestinal Symptom Severity Index"
Time frame · 3 months
Improvement 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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (minutes) | Spread |
|---|---|---|
| Lanreotide | 371.52 | 45.18 |
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Lanreotide | 1.48 | 0.27 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| LanreotideOpen label Lanreotide: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart | 0 / 9 | 0 / 9 | 2 / 9 |
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
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 1997
Lamrani et al. 1997British journal of clinical pharmacologycited by 12
PMID 9056054DOI 10.1111/j.1365-2125.1997.tb00034.xPUB-09056054
3 studies on this page
Indexing hint: Case report · 2014
Lybaert et al. 2014Case reports in oncologycited by 1
PMID 24575015PMC3934784DOI 10.1159/000358124PUB-24575015
PubMed tag: none · 1998
Edmunds et al. 1998Alimentary pharmacology & therapeuticscited by 30
PMID 9692691DOI 10.1046/j.1365-2036.1998.00289.xPUB-09692691
PubMed tag: none · 1991
Soudah et al. 1991The New England journal of medicinecited by 262
PMID 1944424DOI 10.1056/nejm199111213252102PUB-01944424
Who could join, as posted.
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