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A Proof of Concept Study of L-Alanyl-L-Glutamine for the Reduction of Peritoneal Adhesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250467
Recruitment Status : Completed
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Temple Therapeutics BV

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.

Condition or disease Intervention/treatment Phase
Adhesion; Peritoneum Drug: L-Alanyl/L-Glutamine Drug: Physiologic saline Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Proof of Concept Study of L-Alanyl-L-Glutamine for the Reduction of Peritoneal Adhesions in Adult Females Undergoing Myomectomy
Actual Study Start Date : February 15, 2015
Actual Primary Completion Date : October 20, 2016
Actual Study Completion Date : October 20, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine

Arm Intervention/treatment
Experimental: L-Alanyl-L-Glutamine
Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of myomectomy.
Drug: L-Alanyl/L-Glutamine
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.
Other Name: Evitar

Placebo Comparator: Placebo-Physiological Saline
Participants receiving intraperitoneal administration of physiological saline at the time of myomectomy.
Drug: Physiologic saline
Other Name: Placebo




Primary Outcome Measures :
  1. Efficacy of L-Alanyl-L-Glutamine [ Time Frame: 6-8 weeks ]
    A statistically significant reduction in the incidence, extent and severity of adhesions observed in the L-Alanyl-L-Glutamine treated group compared to the saline control group using the American Fertility Society grading system.


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by clinical blood work abnormalities and physical examination. [ Time Frame: 8 weeks ]
    Adverse events, adverse drug reactions and clinical laboratory abnormalities will be analyzed be using the chi-square test or Fisher's Exact test. Any continuous measurement in physical examination and clinical laboratory will be analyzed by t-test or Wilcoxon rank test.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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 17-40
  • 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

Exclusion Criteria:

  • 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
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Responsible Party: Temple Therapeutics BV
ClinicalTrials.gov Identifier: NCT04250467    
Other Study ID Numbers: ADE002
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Temple Therapeutics BV:
Adhesions
Postoperative
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes