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Clinical trial

A Single-arm Open Label Exploratory Clinical Trial to Evaluate Dichloroacetate (DCA) as a Possible Treatment for Endometriosis-associated Pain

ID
Name
AC18127
Description
This is a single-arm open label exploratory clinical trial to evaluate dichloroacetate (DCA) as a possible treatment for treatment of endometriosis-associated pain
Trial arms
Trial start
2019-11-19
Estimated PCD
2021-09-30
Trial end
2021-09-30
Status
Completed
Treatment
Dichloroacetate
6.25 mg/kg BD for 6 weeks increasing to 12.5 mg/kg BD for 6 weeks
Arms:
Dichloroacetate
Other names:
DCA
Size
30
Primary endpoint
To determine whether it is possible to achieve acceptable recruitment and retention rates within defined inclusion/exclusion criteria.
Screening
To determine whether it is possible to achieve acceptable recruitment and retention rates within defined inclusion/exclusion criteria.
Screening
To determine whether it is possible to achieve acceptable recruitment and retention rates within defined inclusion/exclusion criteria.
Throughout the treatment (Week 1- 12)
Eligibility criteria
Inclusion Criteria: * Women aged 18 or over * Weight between 50 and 100kg * Pre-menopausal * Superficial peritoneal endometriosis (ASRM Stage I or II) at laparoscopy, performed within the last three years (and \>2 weeks from surgery) * Pelvic pain for longer than six months * Average pain score of ≥ 4 over the four weeks prior to treatment * Willing to comply with the treatment * Willing to use contraception throughout the trial * Willing and able to complete informed consent Exclusion Criteria: * Evidence of ovarian endometrioma or deep endometriosis (based upon current surgical staging or most recent imaging) * Women who are pregnant or actively trying to get pregnant * Known allergy or hypersensitivity to any excipient of DCA * Breastfeeding * Clinical evidence of pre-existing neuropathy * Diabetes * History of liver disease * History of kidney disease * Taking part in a CTIMP or other interventional non-CTIMP studies * Patient on combination antiretroviral therapy * History of malabsorption syndrome or substantial amount of small bowels or stomach removed
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2024-06-13

1 organization

1 product

1 indication

Organization
University of Edinburgh
Product
Dichloroacetate
Indication
Endometriosis