Pelvic PainNCT02523794
Study of Electro-kinetically Modified Water for the Treatment of Pain Associated With Endometriosis
A study testing Electro-kinetically Modified Water in people with Pelvic Pain, run by Revalesio Corporation at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of electro-kinetically modified water (EMW) beverage, consumed twice daily (BID) for 3 months in the management of endometriosis associated pain, and to evaluate the effect of EMW consumption on analgesic use for endometriosis associated pain. Read more about this study
- Who is it for?
- Ages 16 to 49 years, women only
- Conditions the study is for
- Pelvic Pain
- What is being tested?
- Electro-kinetically Modified Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Premenopausal women, 16 to 49 years of age
- Diagnosed with endometriosis by means of documented surgical visualization (laparoscopy or laparotomy) within 10 years of study entry
- No endometriosis-related surgical procedures within a month of starting study agent
- Has at least 2 days of moderate or severe pain scores for dysmenorrhea (E-diary NRS > 5 of 10) and non-menstrual pelvic pain (E-diary NRS > 5 of 10) during the month prior to starting study agent
- Must have had a menstrual cycle of interval 24-35 days within 3 months of starting study agent
- BMI 18 to 39
- Able to provide written informed consent and able to comply with study procedures for the entire length of the study
Who cannot join
- Pregnant or breastfeeding or planning pregnancy in the next 12 months
- Has been pregnant within 3 months of starting study agent
- Has had a hysterectomy or bilateral oophorectomy
- Has chronic pelvic pain not caused by endometriosis (i.e. inflammatory bowl disease, irritable bowel syndrome, adenomyosis, interstitial cystitis, pelvic adhesive disease, pelvic inflammatory disease) that requires chronic analgesic or narcotic use which would interfere with assessment of endometriosis associated pain
- Current history of undiagnosed abnormal uterine bleeding
- Currently receiving Gonadotropin-releasing hormone (GnRH) agonist or GnRH antagonist or have received any of these types of medications within 6 months of starting study agent
Show all 12Show fewer
- Currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or i.m. medroxyprogesterone acetate (DMPA-IM) or have received any of these within the last 3 months of enrollment
- Currently has an intrauterine device in place
- Use of steroids or immunosuppressive medications on a regular basis within 3 months of enrollment
- Has an unstable medical condition, chronic disease or psychiatric disorder that is deemed by the investigator to be incompatible with participation in the study
- Treatment with any other investigational drug/interventions within 3 months of starting study agent
- History of drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
Official title: A Double Blind, Placebo-controlled Study Evaluating an Electro-kinetically Modified Water for the Treatment of Pain Associated With Endometriosis
The purpose of this study is to evaluate the efficacy of electro-kinetically modified water (EMW) beverage, consumed twice daily (BID) for 3 months in the management of endometriosis associated pain, and to evaluate the effect of EMW consumption on analgesic use for endometriosis associated pain.
Read the detailed description
This is a single center, double-blind, placebo controlled, randomized study to assess the efficacy of EMW versus placebo in the treatment of premenopausal women (16-49 years of age) with endometriosis associated pain. Approximately 40 subjects with endometriosis will be enrolled at Madigan Army Medical Center (MAMC). Subjects will be asked to consume EMW (or placebo) for three months. Subjects will record daily pain levels and other symptoms associated with endometriosis in an electronic diary. In addition to standard of care for this condition, the investigator will monitor the subjects at baseline, Month 1, and Month 3 visits, which will consist of patient questionnaires, blood sampling, and Adverse Events monitoring.
- Conditions
- Pelvic Pain
- Being tested
- Electro-kinetically Modified Water, Placebo
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro-kinetically Modified WaterOther
Subjects assigned to this arm will receive the EMW
PlaceboOther
Purified Drinking Water
| Study group | Role | What they receive |
|---|---|---|
| Electro-kinetically Modified Water | Experimental | Subjects will drink 2 to 3 500 mL bottles of EMW daily for 3 months Receives: Other: Electro-kinetically Modified Water |
| Placebo | Placebo comparator | Subjects will drink 2 to 3 500 mL bottles of purified drinking water daily for 3 months Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endometriosis symptoms using the Composite Pelvic Signs and Symptoms Scale (CPSSS) total composite score.
Measured: 3 Months
Secondary outcomes (7)
Change in dysmenorrhea score on the CPSSS.
Measured: 3 months
Change in non-menstrual pelvic pain score on the CPSSS.
Measured: 3 month
Change in dyspareunia score on the CPSSS.
Measured: 3 months
Change in premenstrual spotting from baseline on a numerical rating scale (NRS)
Measured: 3 month
Change in use of rescue analgesia
Measured: 3 months
Change in endometrioma size as measured by TVUS
Measured: 3 months
Change in endometriosis symptoms using the Endometriosis Health Profile (EHP-30) questionnaire.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revalesio Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Geneva Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523794
- Sponsor's protocol ID
- 14.1.1.H1
- Status last verified
- Jan 2018
- First submitted
- 6 Aug 2015
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo-controlled Study Evaluating an Electro-kinetically Modified Water for the Treatment of Pain Associated With Endometriosis
- ClinicalTrials.gov ID
- NCT02523794
- Acronym / sponsor ID
- 14.1.1.H1
- Conditions
- Pelvic Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Revalesio CorporationIndustry (pharma, biotech, devices)
- Collaborators
- The Geneva Foundation
- Study start
- Aug 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of electro-kinetically modified water (EMW) beverage, consumed twice daily (BID) for 3 months in the management of endometriosis associated pain, and to evaluate the effect of EMW consumption on analgesic use for endometriosis associated pain.
Detailed description
This is a single center, double-blind, placebo controlled, randomized study to assess the efficacy of EMW versus placebo in the treatment of premenopausal women (16-49 years of age) with endometriosis associated pain. Approximately 40 subjects with endometriosis will be enrolled at Madigan Army Medical Center (MAMC). Subjects will be asked to consume EMW (or placebo) for three months. Subjects will record daily pain levels and other symptoms associated with endometriosis in an electronic diary. In addition to standard of care for this condition, the investigator will monitor the subjects at baseline, Month 1, and Month 3 visits, which will consist of patient questionnaires, blood sampling, and Adverse Events monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electro-kinetically Modified Water | Experimental | Other: Electro-kinetically Modified WaterSubjects will drink 2 to 3 500 mL bottles of EMW daily for 3 months |
| Placebo | Placebo comparator | Other: PlaceboSubjects will drink 2 to 3 500 mL bottles of purified drinking water daily for 3 months |
Who may qualify
- Ages
- 16 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Premenopausal women, 16 to 49 years of age
- Diagnosed with endometriosis by means of documented surgical visualization (laparoscopy or laparotomy) within 10 years of study entry
- No endometriosis-related surgical procedures within a month of starting study agent
- Has at least 2 days of moderate or severe pain scores for dysmenorrhea (E-diary NRS > 5 of 10) and non-menstrual pelvic pain (E-diary NRS > 5 of 10) during the month prior to starting study agent
- Must have had a menstrual cycle of interval 24-35 days within 3 months of starting study agent
Key exclusion criteria (12 listed)
- Pregnant or breastfeeding or planning pregnancy in the next 12 months
- Has been pregnant within 3 months of starting study agent
- Has had a hysterectomy or bilateral oophorectomy
- Has chronic pelvic pain not caused by endometriosis (i.e. inflammatory bowl disease, irritable bowel syndrome, adenomyosis, interstitial cystitis, pelvic adhesive disease, pelvic inflammatory disease) that requires chronic analgesic or narcotic use which would interfere with assessment of endometriosis associated pain
- Current history of undiagnosed abnormal uterine bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electro-kinetically Modified WaterSubjects assigned to this arm will receive the EMW | Other | Electro-kinetically Modified Water |
| PlaceboPurified Drinking Water | Other | Placebo |
Primary outcome
Change in endometriosis symptoms using the Composite Pelvic Signs and Symptoms Scale (CPSSS) total composite score.
Time frame: 3 Months
7 secondary outcomes
Change in dysmenorrhea score on the CPSSS.
Time frame: 3 months
Change in non-menstrual pelvic pain score on the CPSSS.
Time frame: 3 month
Change in dyspareunia score on the CPSSS.
Time frame: 3 months
Change in premenstrual spotting from baseline on a numerical rating scale (NRS)
Time frame: 3 month
Change in use of rescue analgesia
Time frame: 3 months
Change in endometrioma size as measured by TVUS
Time frame: 3 months
Change in endometriosis symptoms using the Endometriosis Health Profile (EHP-30) questionnaire.
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electro-kinetically Modified Water in people with Pelvic Pain, run by Revalesio Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in endometriosis symptoms using the Composite Pelvic Signs and Symptoms Scale (CPSSS) total composite score. (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.