Clinical Trials Logo
  1. Home
  2. Functional Constipation
  3. NCT02649062
  4. Details
NCT02649062 Clinical Trial

Study of NGM282 in Subjects With Functional Constipation and Healthy Individuals

Functional Constipation Clinical Trial

Official title:
Study of the Pharmacodynamics of NGM282 on Colonic Transit, Bile Acid Homeostasis, and Fecal Fat in Subjects With Functional Constipation and Healthy Individuals

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02649062
Other study ID # 15-0107
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received January 4, 2016
Last updated March 28, 2018
Start date December 2015
Est. completion date January 2017

Study information
Verified date March 2018
Source NGM Biopharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of NGM282 on colonic transit, bile acid homeostasis, and fecal fat in subjects with functional constipation and healthy individuals.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Functional constipation confirmed by modified Rome III criteria or Healthy Volunteer

Exclusion Criteria:

- Structural or metabolic diseases/conditions that affect the GI system

- Diagnosis of dyspepsia, IBS, or significant gastrointestinal symptoms

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• NGM282

Other:
• Placebo

Locations
Country Name City State
United States NGM Clinical Study Site 1 Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
NGM Biopharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effect on Colon Transit, as measured by the movement of food through the colon 9 days
Secondary Clinical Laboratory Assessments 14 days
See also
  Status Clinical Trial Phase
Completed NCT04506801 - The Effect of Probiotics on Functional Constipation in the Elderly N/A
Completed NCT04620161 - A Proof of Concept Study of Pradigastat in Patients With Functional Constipation Phase 2
Active, not recruiting NCT02361749 - Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation Phase 4
Completed NCT03054805 - The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation Phase 4
Not yet recruiting NCT01913665 - The Effect of Bifidobacterium Lactis and Inulin on Functional Constipation N/A
Completed NCT01348152 - Effect of TU-100 in Patients With Functional Constipation Phase 2
Completed NCT01622972 - Mode of Action of Moviprep Phase 4
Completed NCT01212146 - Probiotic-enriched Artichoke in Functional Constipation N/A
Completed NCT04231162 - Effect of an 8-week Bifidobacterium Lactis HN019 Supplementation on Functional Constipation N/A
Not yet recruiting NCT03639142 - Dried Plums (Prunes) vs. Polyethylene Glycol 4000 for Treatment of Functional Constipation in Children Phase 3
Recruiting NCT04918329 - Functional Digestive Disorders Observatory
Completed NCT02592200 - Effect of Lactobacillus Gasseri DSM 27123 on Functional Constipation in Healthy Women N/A
Completed NCT03707002 - Effect of scFOS on Increase in Stool Frequency in Constipated People N/A
Recruiting NCT06083311 - The Efficacy of a Probiotic for Functional Constipation (FC) N/A
Completed NCT04110145 - Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation Phase 2
Recruiting NCT06196073 - Visceral Osteopathy in Functional Constipation N/A
Completed NCT04026113 - Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC) Phase 3
Completed NCT02359396 - A Randomized, Open-label, Three-arm Study of MZRW on Tolerability, Exposure and Pharmacokinetics Phase 1
Completed NCT01847950 - Effects of scFOS on Stool Frequency in People With Functionnal Constipation N/A
Recruiting NCT01274793 - Trial for Quantity-Effect Relationship of Acupuncture With Two-ways Regulation to Treat Functional Enteropathy Phase 1