Short Bowel Syndrome and Teduglutide Versus Placebo

NCT02099084 | Completed Phase 4 Results

• 2 other identifiers: 13-004866UL1TR000135
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This research study was done to see what the effects are of Teduglutide on people with short bowel syndrome (SBS). Teduglutide is a synthetic medication administered as an injection, which has shown to increase intestinal blood flow, inhibit gastric secretion, increase growth of intestinal cells and increase absorption of nutrients. Teduglutide has demonstrated to decrease Total Parenteral Nutrition (TPN) requirements by 20%. Teduglutide is approved by the Food and Drug Administration (FDA) for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. The primary hypotheses for this study were 1) that Teduglutide significantly increases the gastric emptying half time of solids when compared to placebo. 2) Teduglutide will significantly decrease the intestinal permeability and urinary excretion of lactulose when compared to placebo.

Conditions

Short Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

• Gastric Emptying Half-Time (T1/2)

  The time for half of the ingested solids or liquids to leave the stomach.

  approximately 2 hours after radiolabeled meal is ingested

• Overall Gut Transit

  Given the variable extent of the residual length of the small intestine and colon, the proportion emptied from the body at 6 hours was assessed as an overall estimate of the whole gut transit. The 6-hour values for intra-abdominal counts were then compared with the 100% reference values of counts (at time zero, which is immediately after ingestion of the radiolabeled meal) to determine the percentage of isotope retained in the abdomen. 100% minus the percentage of retained isotope reflected the amount emptied from the GI tract.

  baseline, approximately 6 hours after ingestion of radiolabeled meal

Secondary Outcomes (3)

• Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Mannitol

  baseline, approximately 2 hours and 8 hours after ingestion of radiolabeled meal

• Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Lactulose at 2 Hours

  baseline, approximately 2 hours after ingestion of radiolabeled meal

• Change in Small Intestinal and Colonic Permeability as Measured by Lactulose/Mannitol Ratio at 2 Hours

  baseline, approximately 2 hours after ingestion of radiolabeled meal

Other Outcomes (2)

• Stool Weight at 8 Hours

  approximately 8 hours after ingestion of radiolabeled meal

• Urine Volume at 8 Hours

  Start of the ingestion of the radiolabeled meal until 8 hours after the meal

Study Arms (2)

Teduglutide First, then Placebo

EXPERIMENTAL

Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days, followed by a 14-day washout period, and placebo administered subcutaneously for 7 days.

Drug: Teduglutide; Drug: Placebo

Placebo First, then Teduglutide

PLACEBO COMPARATOR

Placebo administered subcutaneously for 7 days, followed by a 14-day washout period, and Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days.

Drug: Teduglutide; Drug: Placebo

Interventions

Teduglutide DRUG

Participants will receive Teduglutide 0.05 mg/kg/d administered subcutaneously.

Also known as: Gattex, Revestive

Placebo First, then Teduglutide; Teduglutide First, then Placebo

Placebo DRUG

Participants will receive placebo matching study drug, administered subcutaneously.

Placebo First, then Teduglutide; Teduglutide First, then Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Short bowel syndrome
• Dependent on parenteral nutrition

You may not qualify if:

• Pregnant, trying to become pregnant or lactating
• Diabetes
• Alcohol or drug abuse within the last year by history
• Active Crohn's disease as evaluated by standard procedures employed by the investigator
• History of radiation enteritis, scleroderma, celiac disease, tropical sprue, diabetes, chronic pseudo-obstruction or malignancies
• Previous use of Teduglutide or potential allergies to Teduglutide or its constituents
• Any hospitalization within 1 month before screening
• Use of Octreotide, intravenous glutamine growth hormone or growth factors such as native Glucagon-like Peptide 2 (GLP-2) within the last 12 weeks
• Infliximab or other biological agents, Azathioprine, Methotrexate, Cyclosporine, Tacrolimus, Sirolimus, should be stable for at least 8 weeks prior to baseline and remain stable during the study
• \- Any investigational drug within last 30 days
• Diuretics and oral rehydration solutions will be required to be stable for ≥4 weeks prior to baseline evaluations and remain stable during the study
• Change in dose of antimotility or secretory agents from 2 days prior to, and throughout the two phases and washout periods of the study
• Use of tobacco products within the prior 1 month (since nicotine can affect permeability)
• Use of NSAIDS or aspirin within the past week
• Use of oral corticosteroids within the previous 6 weeks

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Iturrino J, Camilleri M, Acosta A, O'Neill J, Burton D, Edakkanambeth Varayil J, Carlson PJ, Zinsmeister AR, Hurt R. Acute Effects of a Glucagon-Like Peptide 2 Analogue, Teduglutide, on Gastrointestinal Motor Function and Permeability in Adult Patients With Short Bowel Syndrome on Home Parenteral Nutrition. JPEN J Parenter Enteral Nutr. 2016 Nov;40(8):1089-1095. doi: 10.1177/0148607115597644. Epub 2015 Jul 28.

  PMID: 26223941 RESULT

MeSH Terms

Conditions

Short Bowel Syndrome

Interventions

teduglutide; ALX-0600

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Michael Camilleri
• Organization: Mayo Clinic

camilleri.michael@mayo.edu

507-284-6218

Study Officials

• Michael Camilleri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: March 28, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: February 22, 2016
• Results First Posted: February 22, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)