A Clinical Study of Alanyl-Glutamine for Reduction of Post-Myomectomy Adhesions

NCT01701193 | Completed Phase 1 Results

• 1 other identifier: Ade002
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates whether L-Alanyl-L-Glutamine can reduce the incidence, extent and severity of adhesions after myomectomy. Half of the participants will receive L-Alanyl-L-Glutamine and the other half of participants will receive a saline placebo at the time of myomectomy.

Conditions

Pelvic Adhesions

Outcome Measures

Primary Outcomes (1)

• Number of Participants in Which Adhesions Were Prevented.

  The American Fertility Society (AFS) grading system for adhesions was used to assess incidence of adhesions. Adhesion prevention was determined through grading of adhesions at the time of myomectomy (initial surgery) and at the time of second look surgery and compared.

  6-8 weeks

Secondary Outcomes (1)

• Adverse Events, Adverse Drug Reactions and Clinical Laboratory Abnormalities.

  8 weeks

Study Arms (4)

Physiological saline- Laparoscopic

PLACEBO COMPARATOR

Participants receiving intraperitoneal administration of physiological saline at the time of laparoscopic myomectomy.

Drug: Physiologic saline

L-Alanyl/L-Glutamine- Laparoscopic

EXPERIMENTAL

Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of laparoscopic myomectomy.

Drug: L-Alanyl/L-Glutamine

Physiological saline- Laparotomy

PLACEBO COMPARATOR

Participants receiving intraperitoneal administration of physiological saline at the time of myomectomy (laparotomy).

Drug: Physiologic saline

L-Alanyl/L-Glutamine- Laparotomy

EXPERIMENTAL

Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of myomectomy (laparotomy).

Drug: L-Alanyl/L-Glutamine

Interventions

L-Alanyl/L-Glutamine DRUG

Sterile solution of L-Alanyl-L-Glutamine, 400mg/mL in water for injection. It is dosed at 1g/kg of body weight and is instilled into the peritoneum at the time of surgery. The active ingredient, glutamine, is a conditionally essential amino acid component of nutritional supplements.

Also known as: Evitar

L-Alanyl/L-Glutamine- Laparoscopic; L-Alanyl/L-Glutamine- Laparotomy

Physiologic saline DRUG

Placebo

Physiological saline- Laparoscopic; Physiological saline- Laparotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are female
• Subjects are 18 years of age or older at the time of consent
• Subjects have a BMI between 17-40
• Subjects must have signed informed consent form
• Subjects have a preoperative diagnosis of uterine fibroids and plan to have a myomectomy completed surgically as part of their standard of care
• Subjects must have a physical examination and compliance assessment

You may not qualify if:

• Subjects whose BMI is outside the range of 17-40
• Subjects participating in another clinical trial with a drug or 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 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 medication
• Subjects who have been treated with Methotrexate or other chemotherapeutics agents
• Subjects with an American Fertility Society score of Stage D at the time of myomectomy as determined by the surgeon
• Positive viral serology screening results for hepatitis B surface antigen, antibodies to hepatitis C virus or human immunodeficiency

Sponsors & Collaborators

• Temple Therapeutics BV: lead

Study Sites (1)

8Surgery and Endoscopy Department of Kharkiv Medical Academy of Postgraduate Education Kharkiv City Clinical Multi-field Hospital

Kharkiv, Ukraine

Location

MeSH Terms

Interventions

alanylglutamine

Limitations and Caveats

There were no limitations and caveats to the trial that would impact the integrity, analysis or interpretation of the trial results. Dropouts were accounted for in the study design and those excluded did not impact the statistics and/or the power of the trial.

Results Point of Contact

• Title: Roger Pierson, PhD
• Organization: University of Saskatchewan

roger.pierson@usask.ca

306-884-1059

Study Officials

• Donna Chizen, MD, FRCSC

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: October 5, 2012
• Study Start: February 15, 2015
• Primary Completion: October 20, 2016
• Study Completion: October 20, 2016
• Last Updated: May 7, 2021
• Results First Posted: May 7, 2021

Record last verified: 2021-03

Locations

UA (1)