EndometriosisPhase 2NCT06834997
Dronabinol As an Adjunct for Reducing Pain (DARP)-Texas Children's Hospital
A Phase 2 study testing Dronabinol Capsules in people with Endometriosis and Endometriosis Related Pain, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
This exploratory, proof-of-concept study is a double-blind (participants and investigators will be blinded), placebo-controlled, randomized, two-arm clinical trial of Marinol [dronabinol, synthetic Δ9-tetrahydrocannabinol (THC)] for e endometriosis-associated chronic pelvic pain (endo-CPP) with a 2:1 allocation ratio. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Endometriosis, Endometriosis Related Pain, Endometriosis, Pain
- What is being tested?
- Dronabinol Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2026to 30 Dec 2028
- Phase
- Phase 2
- 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 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Ability to take oral medication per protocol.
- Female, aged 18-64 years.
- Females aged ≥ 18 years clinically diagnosed with endometriosis meeting one of the following criteria: a. Patients with previous surgical confirmation of endometriosis and a high suspicion of recurrence b. Patients with imaging (MRI or ultrasonography) findings highly suggestive of endometriosis and confirmed after surgery.
- Has chronic endometriosis pain that has persisted at least 3 months and has resulted in pain as determined by the Endometriosis Health Profile Questionnaire (EHP-30).
Show all 11Show fewer
- For females of reproductive potential: currently practicing an effective form of two types of birth control, which are defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, for at least 1 month prior to screening and agrees to use such a method during study participation and for an additional 4 weeks after the end of study medication administration unless she is surgically sterile, partner is surgically sterile, or she is postmenopausal (one year): a. contraceptive sponge, b. patch, c. double barrier (diaphragm/spermicidal or condom/spermicidal), d. intrauterine contraceptive system, e etonogestrel implant, f. medroxyprogesterone acetate contraceptive injection, g. complete abstinence from sexual intercourse, and/or hormonal vaginal contraceptive ring.
- Patients using oral contraceptives, vaginal ring for contraception and/or management of endometriosis, can be included if both they and their primary provider agree to stopping their medication and transitioning to dronabinol (THC) as the primary treatment of endometriosis throughout the study period
- Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration.
- On a stable pain treatment (pharmacological or otherwise) for ≥3 months at the time of the screening and agree to refrain from adding new analgesic medications or increasing their current dose of analgesic medications for the duration of the study.
- Due to the inability to translate patient facing documents into various languages the investigators will only recruit English speaking participants
Who cannot join
- Current and unwilling to stop use of cannabis/marijuana and any other cannabinoids (CBD), including over the counter CBD products.
- Known allergic reactions to cannabis, CBD, THC, or components of the study interventions.
- Have Blood Urea Nitrogen or Creatinine levels outside the normal range, or other clinically significant laboratory abnormalities
- Current use of automated external defibrillator (AED)
- Chronic daily opioid use and any chronic pain or frequently reoccurring pain condition, other than endometriosis, that is treated with opioids for > 14 days per month
- Women with a BMI > 35 kg/m2
Show all 27Show fewer
- Current use of barbiturates, benzodiazepines, ethanol, lithium, buspirone, muscle relaxants which in the opinion of the P.I. and/or the admitting clinician would preclude the safe and/or successful completion of the study.
- Current use of amphetamines, other sympathomimetic agents, atropine, amoxapine, scopolamine, antihistamines, other anticholinergic agents, amitriptyline, or desipramine, within 3 months of randomization
- Treatment with another investigational drug or other intervention within 3 months of the screening visit.
- Pregnancy, plans to become pregnant, or lactation.
- Any interventional pain procedures within 6 weeks prior to screening or at any point during study enrollment.
- Surgical intervention or introduction/increased dose of an opioid or analgesic regimen at any point during study enrollment
- Implanted spinal cord or dorsal root ganglion stimulator for pain treatment.
- Meets DSM-V criteria for a current major psychiatric illness, such as bipolar disorder, or psychosis which in the opinion of the P.I. and/or the admitting clinician would preclude the safe and/or successful completion of the study.
- Have a history of substance abuse or dependence which in the opinion of the P.I. and/or the admitting clinician would preclude the safe and/or successful completion of the study.
- Have an increased risk of suicide that necessitates inpatient treatment or warrants therapy excluded by the protocol, and/or current suicidal plan, per investigator clinical judgement, based on interview and defined on the Columbia Suicidality Severity Rating Scale (C-SSRS).
- Have a history of seizures which in the opinion of the P.I. and/or the admitting clinician would preclude the safe and/or successful completion of the study.
- Have uncontrolled renal, hepatic, or other systemic disorders that in the opinion of the clinician may jeopardize the patient's safe participation in this study.
- Have a history of cardiac disorders which in the opinion of the P.I. and/or the admitting clinician would preclude the safe and/or successful completion of the study.
- Myocardial infarction or stroke in the previous 6 months.
- Resting heart rate of > 120 or Systolic blood pressure > 140 mm Hg, or diastolic blood pressure > 90 mm Hg.
- Any uncontrolled communicable disease (e.g., HIV/AIDS, tuberculosis, COVID, etc.) which in the opinion of the P.I. and/or the admitting clinician would preclude the safe and/or successful completion of the study.
- Have any other illness, condition, or use of medications, which in the opinion of the P.I. and/or the admitting clinician would preclude the safe and/or successful completion of the study.
- Have ECG abnormalities at screening including but not limited to bradycardia (less than 55 beats per minute); prolonged QTc interval (greater than 450 msec); Wolff-Parkinson White syndrome; wide complex tachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle branch block.
- Have chronic alcohol use (defined as greater then 3 drinks per day, averaged over one week)
- Known history of or suspected breast cancer on screening physical exam
- Current use of a progestin-containing contraceptive implant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baylor College of Medicine
Hosuton, Texas, 77030
Michael E DeBakey VA Medical Center
Houston, Texas, 77030
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Explore The Safety And Therapeutic Potential Of Cannabinoids As An Adjunct For Reducing Pain (Carp)- TCH
This exploratory, proof-of-concept study is a double-blind (participants and investigators will be blinded), placebo-controlled, randomized, two-arm clinical trial of Marinol [dronabinol, synthetic Δ9-tetrahydrocannabinol (THC)] for e endometriosis-associated chronic pelvic pain (endo-CPP) with a 2:1 allocation ratio. Up to 75 subjects will be enrolled in this pilot study and randomized to receive doses of THC (up to 30 mg/day), orally, over 8 weeks. This study will be conducted at a single site; it does not include any stratifications, and there is no interim analysis planned. Notably, the goal is to determine whether there is enough evidence of the safety of THC to support the development of later-phase clinical trials. Thus, detailed developmental plans are contingent on the outcomes of this study.
Read the detailed description
Endometriosis is a progressive, chronic inflammatory disorder that affects approximately 10% of women of reproductive age, with up to 70% to 90% of patients experiencing pelvic pain symptoms, thereby reducing their quality of life, and decreasing labor productivity. Current standard treatments for endometriosis-associated chronic pelvic pain (endo-CPP) include progestin-based hormonal treatments, such as combined oral contraceptive (OC) pills, gonadotropin-releasing hormone (GnRH) analogs, and laparoscopic surgeries. However, endo-CPP often persists even after laparoscopic excision of endometriosis lesions, indicating that controlling disease progression does not necessarily lead to pain relief. As pain is an important factor in endometriosis, optimal analgesia should be sought, which, to date, has primarily been treated with non-steroidal anti-inflammatory drugs (NSAIDs), metamizole, or, in extreme cases, opioids. However, the response to NSAIDs is often ineffective. Additionally, NSAIDs are associated with a higher risk of gastrointestinal bleeding. As for metamizole, agranulocytosis is the most notorious adverse event, along with metamizole-associated hepatotoxicity. Although opioids are generally not recommended for pain relief in women with endometriosis, opioid prescriptions have been identified for women diagnosed with endometriosis within the past year in the United States (As-Sanie S, 2021). Patients undergoing robotic surgery for endometriosis use over two times as many opioids postoperatively as patients without endometriosis and experience higher perceived postoperative pain. Women with endometriosis have a four-fold greater risk of chronic opioid use compared to those without endometriosis. Opioids are highly addictive, and the use of both synthetic and natural opioids can quickly result in dependence, which includes physical and/or psychological dependence, as well as opioid use disorder. Side effects of opioid medications are generally dose-dependent and include constipation, miosis, sedation, and respiratory depression. However, the efficacy of THC in endo-CPP remains uncertain.
- Being tested
- Dronabinol Capsules, Placebo
- Keywords
- Endometriosis Related Pain, Endometriosis
- Medical subject headings
- Endometriosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dronabinol CapsulesDrug
Also called Marinol, delta-9-tetrahydrocannabinol
Eligible subjects will be randomized (2:1) to dronabinol or placebo, administered orally. The dose of dronabinol will be titrated such that on Day 1, subjects will take 2.5 mg, twice. On subsequent days patients may gradually increase the total number of doses, by one dose each day, as needed and tolerated until either the optimal dose is achieved, or the dose reaches 30 mg THC per day.
PlaceboDrug
Matching placebo will be prepared and administered in the same manner as the active medication. Titration will occur in a masked fashion such that individuals assigned to placebo undergo a similar perceived titration process.
| Study group | Role | What they receive |
|---|---|---|
| Dronabinol | Experimental | Dronabinol capsules, over-encapsulated with filler to match the appearance of the placebo capsule, up to 15 mg, twice per day for 8 weeks. Receives: Drug: Dronabinol Capsules |
| Placebo | Placebo comparator | Capsules with placebo (i.e., cellulose filler), twice per day for 8 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
For change in pain intensity from baseline to 8-weeks, the investigators will estimate the mean within each arm using the The Endometriosis Health Profile Questionnaire (EHP-30). 30 point scale ranging from 0 (Never) to 5 (Always).
Measured: Baseline to 8-weeks
Safety Analysis
AEs will be coded using the most recent version of the Medical Dictionary of Regulatory Activities (MedDRA) preferred terms and will be grouped by system, organ, and class (SOC) designation. The severity, frequency, and relationship of AEs to investigational product will be presented by preferred term by SOC grouping. Listings of each individual AE including start date, stop date, severity, relationship, outcome, and duration will be provided.
Measured: Baseline to 8-weeks
Secondary outcomes (4)
Analgesic Use Log
Analgesic Use Change in Analgesic Use Log scores Day 1 to 56 Secondary analyses will use proper tests and appropriate statistical methods at a significance level of 0.05 (2-sided).
Measured: Baseline to 8-weeks
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
The severity of pain will be assessed by the validated scale within the Patient-Reported Outcomes Measurement Information System (PROMIS) is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 8 domains-this outcome measure reports one of the 7 domains, anxiety: Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity. Responses rage from 5 (Without any difficulty) to 0 (Unable to do) on the Physical Function item, 1 (Never) to 5 (Always) on Anxiety, Depression, Ability to Participate in Social Roles and Activities items, 1 (Not at all) to 5 (Very Much) on the Fatigue, Sleep Disturbance, and Pain Interference items, 0 (No pain) to 10 (Worst Pain Imaginable ) on the Pain Intensity.
Measured: Baseline to 8-weeks
Profile of Mood States (POMS questionnaire)
Changes in POMS . Scale range is 1 to 5 and describes how the participant feels at the time the assessment is administered. Scale of 1, the lowest score, describes a feeling of Not At All right now for the mood and the scale of 5 gives the highest score representing a feeling of Extremely for the mood.
Measured: Baseline to 8-weeks
Visual Pain Scale
The Faces Pain Scale, a visual analogue scale (VAS), is self-report measure of pain intensity on the widely accepted 0-to-10 metric.
Measured: Baseline to 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Apr 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Why it stopped: Due to an ongoing national shortage of dronabinol, the study is being discontinued. Given the inability to ensure consistent medication availability, continuation of the study would compromise protocol integrity and participant safety.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Parallel Groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher D. Verrico, Baylor College of Medicine
- Investigators
- Christopher Verrico, PhD in Pharmacology, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834997
- Sponsor's protocol ID
- H-56181
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fitzcharles MA, Baerwald C, Ablin J, Hauser W. Efficacy, tolerability and safety of cannabinoids in chronic pain associated with rheumatic diseases (fibromyalgia syndrome, back pain, osteoarthritis, rheumatoid arthritis): A systematic review of randomized controlled trials. Schmerz. 2016 Feb;30(1):47-61. doi: 10.1007/s00482-015-0084-3.
PubMed 26767993
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Explore The Safety And Therapeutic Potential Of Cannabinoids As An Adjunct For Reducing Pain (Carp)- TCH
- ClinicalTrials.gov ID
- NCT06834997
- Acronym / sponsor ID
- H-56181
- Keywords
- Endometriosis Related Pain, Endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to an ongoing national shortage of dronabinol, the study is being discontinued. Given the inability to ensure consistent medication availability, continuation of the study would compromise protocol integrity and participant safety.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 19 Feb 2025 (actual)
- 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.
This exploratory, proof-of-concept study is a double-blind (participants and investigators will be blinded), placebo-controlled, randomized, two-arm clinical trial of Marinol [dronabinol, synthetic Δ9-tetrahydrocannabinol (THC)] for e endometriosis-associated chronic pelvic pain (endo-CPP) with a 2:1 allocation ratio. Up to 75 subjects will be enrolled in this pilot study and randomized to receive doses of THC (up to 30 mg/day), orally, over 8 weeks. This study will be conducted at a single site; it does not include any stratifications, and there is no interim analysis planned. Notably, the goal is to determine whether there is enough evidence of the safety of THC to support the development of later-phase clinical trials. Thus, detailed developmental plans are contingent on the outcomes of this study.
Detailed description
Endometriosis is a progressive, chronic inflammatory disorder that affects approximately 10% of women of reproductive age, with up to 70% to 90% of patients experiencing pelvic pain symptoms, thereby reducing their quality of life, and decreasing labor productivity. Current standard treatments for endometriosis-associated chronic pelvic pain (endo-CPP) include progestin-based hormonal treatments, such as combined oral contraceptive (OC) pills, gonadotropin-releasing hormone (GnRH) analogs, and laparoscopic surgeries. However, endo-CPP often persists even after laparoscopic excision of endometriosis lesions, indicating that controlling disease progression does not necessarily lead to pain relief. As pain is an important factor in endometriosis, optimal analgesia should be sought, which, to date, has primarily been treated with non-steroidal anti-inflammatory drugs (NSAIDs), metamizole, or, in extreme cases, opioids. However, the response to NSAIDs is often ineffective. Additionally, NSAIDs are associated with a higher risk of gastrointestinal bleeding. As for metamizole, agranulocytosis is the most notorious adverse event, along with metamizole-associated hepatotoxicity. Although opioids are generally not recommended for pain relief in women with endometriosis, opioid prescriptions have been identified for women diagnosed with endometriosis within the past year in the United States (As-Sanie S, 2021). Patients undergoing robotic surgery for endometriosis use over two times as many opioids postoperatively as patients without endometriosis and experience higher perceived postoperative pain. Women with endometriosis have a four-fold greater risk of chronic opioid use compared to those without endometriosis. Opioids are highly addictive, and the use of both synthetic and natural opioids can quickly result in dependence, which includes physical and/or psychological dependence, as well as opioid use disorder. Side effects of opioid medications are generally dose-dependent and include constipation, miosis, sedation, and respiratory depression. However, the efficacy of THC in endo-CPP remains uncertain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Parallel Groups
| Arm | Type | Receives |
|---|---|---|
| Dronabinol | Experimental | Drug: Dronabinol CapsulesDronabinol capsules, over-encapsulated with filler to match the appearance of the placebo capsule, up to 15 mg, twice per day for 8 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboCapsules with placebo (i.e., cellulose filler), twice per day for 8 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Ability to take oral medication per protocol.
- Female, aged 18-64 years.
- Females aged ≥ 18 years clinically diagnosed with endometriosis meeting one of the following criteria: a. Patients with previous surgical confirmation of endometriosis and a high suspicion of recurrence b. Patients with imaging (MRI or ultrasonography) findings highly suggestive of endometriosis and confirmed after surgery.
Key exclusion criteria (27 listed)
- Current and unwilling to stop use of cannabis/marijuana and any other cannabinoids (CBD), including over the counter CBD products.
- Known allergic reactions to cannabis, CBD, THC, or components of the study interventions.
- Have Blood Urea Nitrogen or Creatinine levels outside the normal range, or other clinically significant laboratory abnormalities
- Current use of automated external defibrillator (AED)
- Chronic daily opioid use and any chronic pain or frequently reoccurring pain condition, other than endometriosis, that is treated with opioids for > 14 days per month
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 |
|---|---|---|
| Dronabinol CapsulesAlso: Marinol, delta-9-tetrahydrocannabinolEligible subjects will be randomized (2:1) to dronabinol or placebo, administered orally. The dose of dronabinol will be titrated such that on Day 1, subjects will take 2.5 mg, twice. On subsequent days patients may gradually increase the total number of doses, by one dose each day, as needed and tolerated until either the optimal dose is achieved, or the dose reaches 30 mg THC per day. | Drug | Dronabinol |
| PlaceboMatching placebo will be prepared and administered in the same manner as the active medication. Titration will occur in a masked fashion such that individuals assigned to placebo undergo a similar perceived titration process. | Drug | Placebo |
Primary outcome
Pain Intensity
Time frame: Baseline to 8-weeks
For change in pain intensity from baseline to 8-weeks, the investigators will estimate the mean within each arm using the The Endometriosis Health Profile Questionnaire (EHP-30). 30 point scale ranging from 0 (Never) to 5 (Always).
Safety Analysis
Time frame: Baseline to 8-weeks
AEs will be coded using the most recent version of the Medical Dictionary of Regulatory Activities (MedDRA) preferred terms and will be grouped by system, organ, and class (SOC) designation. The severity, frequency, and relationship of AEs to investigational product will be presented by preferred term by SOC grouping. Listings of each individual AE including start date, stop date, severity, relationship, outcome, and duration will be provided.
4 secondary outcomes
Analgesic Use Log
Time frame: Baseline to 8-weeks
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: Baseline to 8-weeks
Profile of Mood States (POMS questionnaire)
Time frame: Baseline to 8-weeks
Visual Pain Scale
Time frame: Baseline to 8-weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Background: PubMed 26767993Fitzcharles MA, Baerwald C, Ablin J, Hauser W. Efficacy, tolerability and safety of cannabinoids in chronic pain associated with rheumatic diseases (fibromyalgia syndrome, back pain, osteoarthritis, rheumatoid arthritis): A systematic review of randomized controlled trials. Schmerz. 2016 Feb;30(1):47-61. doi: 10.1007/s00482-015-0084-3.
- Individual participant dataSharing planned: Undecided
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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.
Christopher Verrico, PhD in Pharmacology principal investigator
Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dronabinol Capsules in people with Endometriosis and Endometriosis Related Pain, run by Baylor College of Medicine at 2 sites 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 11 inclusion and 27 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: withdrawn, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pain Intensity (time frame: Baseline to 8-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06834997, which also lists 1 linked publication.
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 13 Mar 2026.