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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.
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
  Purpose

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


Condition Intervention Phase
Pelvic Adhesions
 Drug: Amino Acid
Drug: Saline
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AdeTherapeutics Inc.:

Primary Outcome Measures:
  • Adhesion Reduction [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events in patients from dose administration to 8-week follow up [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 38
Study Start Date: October 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline
1g/kg of body weight, 1 time intra-abdominal administration at time of surgery
 Drug: Saline
Placebo Comparator
Experimental: Amino Acid
1g/kg of body weight, 1 time intra-abdominal administration at time of surgery
 Drug: Amino Acid
Dipeptide

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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. Intergel® Adhesion Prevention Solution, Seprafilm® Membrane)
  • Subjects taking anti-epileptic medications
  • Subjects who have been treated with Methotrexate or other chemotherapeutic agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701193

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

Locations
Canada, Saskatchewan
Saskatoon Health Region Recruiting
Saskatoon, Saskatchewan, Canada
Contact: Dominique C Singh, RN     (306) 292-7756     dominique.singh@usask.ca    
Principal Investigator: Donna Chizen, MD, FRCSC            
Sponsors and Collaborators
AdeTherapeutics Inc.
University of Saskatchewan
Investigators
Principal Investigator: Donna Chizen, MD, FRCSC University of Saskatchewan
  More Information

No publications provided

Responsible Party: AdeTherapeutics Inc.
ClinicalTrials.gov Identifier: NCT01701193     History of Changes
Other Study ID Numbers: ADE001-2011
Study First Received: October 3, 2012
Last Updated: October 3, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Tissue Adhesions
Pregnancy, Ectopic
Cicatrix
 Fibrosis
Pathologic Processes
Pregnancy Complications

ClinicalTrials.gov processed this record on May 23, 2013