A proof-of-concept, dose finding, controlled, single-senter, randomized, cross-over, double-blind, fixed dose phase 2 trial with ZP1848 in patients with Short Bowel Syndrome

Phase 1

Conditions: Short Bowel Syndrome (SBS)
MedDRA version: 18.1Level: PTClassification code 10049416Term: Short-bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2015-002826-38-DK

Lead Sponsor: Zealand Pharma A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. 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.
2. Age 18 years and 90 years
3. Stable SBS patients with intestinal insufficiency or failure, where the last surgical
resection of gut tissue was performed at least 1 year ago
4. A stable PS volume ( < 25% change in volume or energy content) for four weeks prior to
randomization for patients requiring PS
5. 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.
6. Stable body weight (<5% weight deviance in the three months prior to screening)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

8. Patients with known or suspected intestinal strictures of clinical relevance as judged by
the Investigator
11. Active inflammatory bowel disease (IBD) or fistula during the screening period as judged
by conventional means of the Investigator.
12. Crohn’s disease patients not being in clinical remission for the last 12 weeks prior to
randomization
13. 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
15. 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)
20. eGFR (by the MDRD formula) <30 mL/min/1.73 m2
21. Clinically meaningful renal disease as judged by the Investigator