Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus

Helsinn Healthcare

Status and phase: Completed; Phase 2

Conditions: Ileus

Treatments: Drug: placebo; Drug: Ipamorelin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00672074

ST-IPAM-201

Details and patient eligibility

About

The purpose of this study is to determine if ipamorelin is safe and effective in the management of post-operative ileus.

Full description

The safety and efficacy of ipamorelin in the management of post-operative ileus

Enrollment: 117 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• willing to comply with protocol
• undergoing bowel resection surgery
• ASA Class I-III
• Females must not be pregnant
• Body weight 40-150 kg

Exclusion criteria

• mentally incompetent or unable to provide informed consent
• clinically unstable
• significant liver disease
• clinically significant lab or EKG abnormalities
• alcohol or illicit drug abuse
• history of or current surgery that would prevent proper evaluation of safety or efficacy of drug

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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117 participants in 2 patient groups, including a placebo group

1 Ipamorelin

Active Comparator group

Treatment:

Drug: Ipamorelin

2 Placebo

Placebo Comparator group

Treatment:

Drug: placebo