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A Phase I Study For the Reduction of Scar Tissue in Adult Females Undergoing Surgery for an Ectopic Pregnancy

Information source: AdeTherapeutics Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pelvic Adhesions

Intervention: Amino Acid (Drug); Saline (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: AdeTherapeutics Inc.

Official(s) and/or principal investigator(s):
Donna Chizen, MD, FRCSC, Principal Investigator, Affiliation: University of Saskatchewan

Overall contact:
Dominique C Singh, RN, Phone: (306) 292-7756, Email: dominique.singh@usask.ca

Summary

The purpose of this study is to determine whether an amino acid is an effective treatment to prevent abdominal/pelvic scar tissue.

Clinical Details

Official title: A Randomized, Double-Blind, Placebo Controlled Phase I Study of an Amino Acid For the Reduction of Peritoneal Adhesions in Adult Females Undergoing a Laparoscopic Salpingostomy for the Removal of an Ectopic Pregnancy

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

Primary outcome: Adhesion Reduction

Secondary outcome: Adverse events in patients from dose administration to 8-week follow up

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Subjects are female

- Subjects are 18 years of age or older at the time of consent

- Subjects have a BMI between 17 and 35

- Subjects or subject's legal representative must have signed informed consent form

- Subjects have a preoperative diagnosis of an ectopic pregnancy with ultrasonographic

confirmation of absence of an intrauterine ectopic pregnancy Exclusion Criteria:

- Subjects whose BMI is outside the range of 17 - 35

- Subjects participating in another clinical trial with a drug or a device

- Subjects who have participated in a clinical trial with a drug or device within 30

days prior to this study

- Subjects with suspected or diagnosed co-existing intrauterine pregnancy

- Subjects with suspected intraabdominal infection

- Subjects who are immunocompromised

- Subjects diagnosed with cancer

- Subjects treated with hemostatic agents (e. g. fibrin sealant, collagen, oxidized

cellulose)

- Subjects treated with adhesion prevention agents other than the Anti-Adhesion Product

(APP) (e. g. IntergelĀ® Adhesion Prevention Solution, SeprafilmĀ® Membrane)

- Subjects taking anti-epileptic medications

- Subjects who have been treated with Methotrexate or other chemotherapeutic agents

Locations and Contacts

Dominique C Singh, RN, Phone: (306) 292-7756, Email: dominique.singh@usask.ca

Saskatoon Health Region, Saskatoon, Saskatchewan, Canada; Recruiting
Dominique C Singh, RN, Phone: (306) 292-7756, Email: dominique.singh@usask.ca
Donna Chizen, MD, FRCSC, Principal Investigator
Additional Information

Starting date: October 2012
Last updated: October 3, 2012

Page last updated: August 23, 2015

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