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
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