Short Bowel Syndrome
Conditions
Brief summary
A proof-of-concept, dose finding, controlled, single-center, randomized, double-blind, fixed dose phase 2 trial with ZP1848 in patients with Short Bowel Syndrome.
Interventions
DRUGZP1848
Sponsors
Larix A/S
Zealand Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Following receipt of verbal and written information about the trial, the patient must provide signed informed consent before any trial related activity is carried out. * Age ≥ 18 years and ≤ 90 years * Stable SBS patients with intestinal insufficiency or failure, where the last surgical resection of gut tissue was performed at least 1 year ago * A stable PS volume ( \< 25% change in volume or energy content) for four weeks prior to randomization for patients requiring PS * Wet weight of fecal excretion ≥ 1500 g/day demonstrated during a hospital stay prior to screening or during at least one day of the first baseline balance study. * Stable body weight (\<5% weight deviance in the three months prior to screening)
Exclusion criteria
* Patients with known or suspected intestinal strictures of clinical relevance as judged by the Investigator * Active inflammatory bowel disease (IBD) or fistula during the screening period as judged by conventional means of the Investigator. * Crohn's disease patients not being in clinical remission for the last 12 weeks prior to randomization * Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months prior to screening * History of cancer (except resected cutaneous basal or squamous cell carcinoma and except in situ cervical cancer) unless it can be documented that the patient has been in a disease-free state for at least 5 years (except colon cancer: patients with a history of colon cancer generally have to be excluded) * eGFR (by the MDRD formula) \<30 mL/min/1.73 m2 * Clinically meaningful renal disease as judged by the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary endpoint is the absolute change from baseline to the end of three week treatment periods of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods. | 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods | 3 weeks |
| Relative change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods | 3 weeks |
| Absolute change from baseline to the end of treatment of wet weight absorption measured separately over each of the two treatment periods | 3 weeks |
| Relative change from baseline to the end of treatment of wet weight absorption measured separately over each of the two treatment periods | 3 weeks |
| Absolute change from baseline to the end of treatment of the intestinal absorption of electrolytes measured separately over each of the two treatment periods | 3 weeks |
| Relative change from baseline to the end of treatment of the intestinal absorption of electrolytes measured separately over each of the two treatment periods | 3 weeks |
| Relative change from baseline to the end of treatment of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods | 3 weeks |
| Relative change from baseline to the end of treatment of the intestinal absorption of macronutrients measured separately over each of the two treatment periods | 3 weeks |
| Change in SF-36 score | 3 weeks |
| Incidence of Adverse Events | 15 weeks |
| Incidence of Anti Drug Antibodies | 15 weeks |
| Absolute change from baseline to the end of treatment of urine weight minus oral intake measured separately over each of the two treatment periods | 3 weeks |
| Relative change from baseline to the end of treatment of urine weight minus oral intake measured separately over each of the two treatment periods | 3 weeks |
| Absolute change from baseline to the end of treatment of the intestinal absorption of macronutrients measured separately over each of the two treatment periods | 3 weeks |
Countries
Denmark
Outcome results
None listed