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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by AdeTherapeutics Inc.
Sponsor:
Collaborator:
University of Saskatchewan
Information provided by (Responsible Party):
AdeTherapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01701193
First received: October 3, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted

October 3, 2012
October 3, 2012
October 2012
October 2013   (final data collection date for primary outcome measure)
Adhesion Reduction [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Adverse events in patients from dose administration to 8-week follow up [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Phase I Study For the Reduction of Scar Tissue in Adult Females Undergoing Surgery for an Ectopic Pregnancy
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Pelvic Adhesions
  • Drug: Amino Acid
    Dipeptide
  • Drug: Saline
    Placebo Comparator
  • Placebo Comparator: Saline
    1g/kg of body weight, 1 time intra-abdominal administration at time of surgery
    Intervention: Drug: Saline
  • Experimental: Amino Acid
    1g/kg of body weight, 1 time intra-abdominal administration at time of surgery
    Intervention: Drug: Amino Acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
38
October 2013
October 2013   (final data collection date for primary outcome measure)

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. Intergel® Adhesion Prevention Solution, Seprafilm® Membrane)
  • Subjects taking anti-epileptic medications
  • Subjects who have been treated with Methotrexate or other chemotherapeutic agents
Female
18 Years to 50 Years
No
Contact: Dominique C Singh, RN (306) 292-7756 dominique.singh@usask.ca
Canada
 
NCT01701193
ADE001-2011
Yes
AdeTherapeutics Inc.
AdeTherapeutics Inc.
University of Saskatchewan
Principal Investigator: Donna Chizen, MD, FRCSC University of Saskatchewan
AdeTherapeutics Inc.
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP