Ulimorelin Study of Efficacy & Safety (ULISES 008)

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

See also
Status	Clinical Trial	Phase
Completed	`NCT01285570` - Ulimorelin Study of Efficacy and Safety (ULISES 007)	Phase 3
Withdrawn	`NCT04872452` - Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders	N/A
Completed	`NCT04880538` - Enteric Neural Precursor Cells (ENPC) in the Human Gut
Completed	`NCT01280344` - Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal Function	Phase 2

See also

Status

Clinical Trial

Phase

Completed

NCT01285570 - Ulimorelin Study of Efficacy and Safety (ULISES 007)

Phase 3

Withdrawn

NCT04872452 - Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders

N/A

Completed

NCT04880538 - Enteric Neural Precursor Cells (ENPC) in the Human Gut

Completed

NCT01280344 - Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal Function

Phase 2

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT01296620
Study type	Interventional
Source	Tranzyme, Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	February 2011
Completion date	March 2012

Ulimorelin Study of Efficacy and Safety (ULISES 008)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms