Hand OsteoarthritisHOPE-eNCT04036929
Can we Use Estrogen-containing Therapy to Improve Pain in Women After Menopause With Hand Osteoarthritis?
A study testing Estrogen-bazedoxifene in people with Hand Osteoarthritis, run by University of Oxford at 3 sites in United Kingdom.
Trial summary
Post-menopausal women aged 40-65 with symptomatic hand osteoarthritis are invited to take part in this feasibility study. The study's aim is to investigate whether it is acceptable to women with painful hand OA to take an estrogen-containing therapy, and what is the best way of collecting some of the information in… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- Estrogen-bazedoxifene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 9 May 2019to 10 Dec 2021
- 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to give informed written consent
- Female, aged 40-65 years old
- In those with an intact uterus: At least 12 months of spontaneous amenorrhea (without any menstrual bleeding in last 12 months) and last menstrual period not more than 10 years ago
- In those who have undergone hysterectomy or are/were using an intrauterine contraceptive device with progesterone local therapy (such as Mirena): Follicle stimulating hormone (FSH) ≥30 milli-International Units per millilitre (mIU/ml) on screening blood test AND a history of menopausal symptoms in the last 1 to 10 years, in keeping with appropriate timing of menopausal status
- Hand pain, aching or stiffness on most days in the last 3 months
- At least 2, painful hand joints of any type (interphalangeal joints (IPJ) or base of thumbs)
Show all 15Show fewer
- Fulfils American College of Rheumatology clinical diagnostic criteria for hand OA (3 or more of following):
- Hard tissue enlargement of 2 or more of the following joints: 2nd or 3rd distal interphalangeal joints (DIPJ), 2nd or 3rd proximal interphalangeal joints (PIPJ), first carpometacarpal joints (CMCJ)
- Hard tissue enlargement of 2 or more of the DIPJs
- Less than 3 swollen metacarpophalangeal joints (MCPJ)
- Deformity of at least one of the joints listed in first point
- OR, for those with base of thumb osteoarthritis only not fulfilling these criteria, has clinical symptoms and examination findings consistent with base of thumb osteoarthritis.
- Hand pain has not responded adequately to National Institute for Health and Care Excellence core guidance for management of OA, including the use of paracetamol or non-steroidal anti-inflammatory drug (NSAID) gel, except where there is contraindication or intolerance
- Average hand pain is reported as typically more than 4 out of 10 in severity, or average hand pain in the last 7 days of 4/10 or more on a visual analogue scale
- In the Investigator's opinion, is able and willing to comply with all study requirements
Who cannot join
- Other cause of hand pain, including inflammatory arthritis, connective tissue disorder, chronic pain or alternative clinical diagnosis such as tenosynovitis or carpal tunnel syndrome
- Pregnancy or breast feeding, or risk of this during study
- Use of one or more prohibited treatments within specified timeframe, or not willing to avoid treatment for the duration of the study:
- Oral contraceptive pill, or systemic HRT within the last 6 months (Use of an intrauterine contraceptive device with progesterone local therapy (Mirena) or vaginal topical estrogen use (known low systemic absorption) are not exclusions to participation)
- Anti-estrogen medication within the last 6 months
- Oral, intramuscular or intraarticular steroid within the last 3 months
Show all 34Show fewer
- Intraarticular hyaluronan to a hand joint within the last 6 months
- Initiation of new oral analgesia within the last 4 weeks
- Initiation of glucosamine, chondroitin, hand exercises or other relevant non- pharmacological therapy within the last 6 weeks
- Hand surgery within the last 6 months, or planned within the next 6 months
- Medications likely to increase hepatic metabolism of study medication, including:
- St. John's Wort
- Anti-convulsants (phenobarbital, phenytoin, carbamazepine, lamotrigine)
- Some anti-infectives (rifampicin, rifabutin, nevirapine, efavirenz, ritonavir and nelfinavir)
- Presence of one or more medical contraindications to the use of systemic hormonal replacement therapy:
- In those aged 40-45 years, FSH <30 mIU/ml on screening blood test, i.e. non- confirmatory of menopausal status
- Any history of breast, endometrial, ovarian or skin cancer
- Any other history of other cancer within 5 years (except treated Basal Cell Carcinoma, BCC)
- Relevant breast issue on routine national breast screening in prior 3 years
- Undiagnosed genital bleeding, or untreated endometrial hyperplasia, active uterine fibroids or endometriosis
- Active or past history of venous thromboembolism (VTE) (including deep venous thrombosis, pulmonary embolism and retinal vein thrombosis), or at high risk of VTE (such as known thrombophilic disorders (such as Protein C, S or anti-thrombin deficiency) or presence of a strong family history of VTE). Women with a first degree relative with a history of VTE, or other strong family history of VTE at the Investigators' discretion.
- Active or past history of arterial thrombo-embolic disease (such as myocardial infarction, angina or stroke) or strong family history of stroke)
- Clinically significant immobility
- Migraine or active epilepsy
- Uncontrolled hypertension (or diastolic pressure greater than 90 mmHg or systolic pressure greater than 145 mmHg at screening visit)
- Uncontrolled diabetes mellitus or uncontrolled hypertriglyceridaemia
- Body Mass Index (BMI) greater than 30
- Active malabsorption syndrome or clinically significant small bowel disease
- Acute liver disease, clinically significant abnormal liver function, active gallbladder disease or porphyria
- Clinically significant renal impairment
- Intolerance to lactose, fructose or glucose (including galactose intolerance, lactase deficiency, fructose intolerance, glucose-galactose malabsorption or sucrase- isomaltase insufficiency)
- Known sensitivity to either conjugated equine estrogens, bazedoxifene or the combination
- Any other significant or uncontrolled disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
- Participants who have participated in another research trial involving an investigational product in the past 8 weeks
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
White Horse Medical Practice, Faringdon Medical Centre
Faringdon, Oxfordshire, SN7 7YU
Charing Cross Hospital, Imperial College Healthcare NHS Trust
London, W6 8RF
Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7HE
About this study
Official title: Hand Osteoarthritis: Investigating Pain Effects in a Randomised Placebo-controlled Feasibility Study of an Estrogen-containing Therapy
Post-menopausal women aged 40-65 with symptomatic hand osteoarthritis are invited to take part in this feasibility study. The study's aim is to investigate whether it is acceptable to women with painful hand OA to take an estrogen-containing therapy, and what is the best way of collecting some of the information in order to facilitate planning a full size trial. The investigator's long-term aim is to find out whether giving estrogen-containing therapy to women after the menopause improves hand OA symptoms.
- Conditions
- Hand Osteoarthritis
- Being tested
- Estrogen-bazedoxifene, Placebo oral tablet
- Keywords
- Osteoarthritis, Hand, Hormone, Pain, Estrogen
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estrogen-bazedoxifeneDrug
Also called Duavive
Conjugated estrogens 0.45 mg-bazedoxifene acetate 20 mg.
Placebo oral tabletDrug
Placebo oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Estrogen-bazedoxifene | Experimental | Tablet, once daily for 6 months. Receives: Drug: Estrogen-bazedoxifene |
| Placebo | Placebo comparator | Closely matched tablet, once daily for 6 months. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Rates of eligible participant identification, rates of recruitment/randomisation from different sources, retention rates
Measured: From the date of recruitment opening until the date of recruitment closing, 1 year
Feasibility: Frequency of adverse events related to the active study medication
Measured: Through study completion, 7 months
Feasibility: Bang's Blinding Index (likelihood of unblinding)
Self-complete questionnaire which assesses likelihood that participant or Investigator have become unblinded
Measured: Week 24
Feasibility: Monitoring study medication compliance (via diaries)
Participants will be asked to record any missed doses of study medication on a paper diary which will be provided at each visit. We will ask participants to bring the diary to each study visit and any missed doses will be recorded in the Case Report Form.
Measured: From randomisation to end of treatment at Week 24
Secondary outcomes (12)
Pain and function: Average hand pain over last 14 days (NRS 0-10)
Numerical Rating Scale 0-to-10, where 0 is "no pain" and 10 is "pain as bad as you can imagine"
Measured: Collected at: Baseline, Week 4, Week 12, Week 24
Pain and function: Remote pain-rating prior to a visit (NRS 0-10)
Numerical Rating Scale 0-to-10, where 0 is "no pain" and 10 is "pain as bad as you can imagine"
Measured: Collected at: Baseline, Week 4, Week 12, Week 24
Pain and function: Prevalence of joint pain elsewhere (pain manikin)
Prevalence of joint pain elsewhere in the 4 weeks preceding the study visit
Measured: Collected at: Baseline, Week 12, Week 24
Pain and function: Functional Index for Hand OA (FIHOA)
Validated measurement of hand OA-related functional impairment. It includes 10 questions scored according to a 4-grade scale. The score ranges from 0 (no functional impairment) to 30 points (maximal impairment).
Measured: Collected at: Baseline, Week 12, Week 24
Pain and function: EQ-5D-5L
Validated measurement of quality of life across five dimensions and their associated levels of severity on a 1 (no problems) to 5 (extreme problems) scale.
Measured: Collected at: Baseline, Week 12, Week 24
Menopause symptoms: The Menopause Specific Quality of Life Questionnaire (MENQOL)
Validated measurement of menopausal symptoms and their associated degree of severity; 30 items in a Likert-scale format. Items are rated as present or not present and if present how bothersome, on a 0 (not bothersome) to 6 (extremely bothersome) scale.
The interventional version is being used here, which includes an additional 3 questions relevant to Hormonal Replacement Therapy (HRT) use which has been used in a trials setting.
Measured: Collected at: Baseline, Week 12, Week 24
Menopause symptoms: Greene Climacteric Scale
A 21-item validated questionnaire that measures a variety of menopausal symptoms on a 4-point Likert scale (0 = "not at all" to 3 = "extremely"), plus one sexual function probe.
Measured: Collected at: Baseline, Week 12, Week 24
Joint appearance: Cosmesis score of Michigan Hand Questionnaire (4 questions, questions 28-31)
Subdomain of hand-specific outcomes instrument that measures outcomes of patients with conditions of, or injury to, the hand or wrist.
Measured: Collected at: Baseline, Week 12, Week 24
Joint appearance: Investigator-recorded tender and swollen joint counts
Investigator examination of tender and swollen hand joints, binary recording (1 swollen, 0 not swollen).
Measured: Collected at: Baseline, Week 12, Week 24
Joint appearance: Photographic recording of swollen hand joints
Standardised digital photography of hands
Measured: Collected at: Baseline, Week 12, Week 24
Joint function: Jamar grip strength - average of 3 measurements
Handgrip strength will be measured in kilograms to the nearest hundred grams in both hands using a Jamar dynamometer.
Both hands will be alternately assessed three times and the average score recorded.
Measured: Collected at: Baseline, Week 12, Week 24
End of Treatment questionnaire (study-specific)
A study specific end of treatment questionnaire will be designed to include items on acceptability.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start9 May 2019
- Primary completion19 Aug 2021
- Study completion10 Dec 2021
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 Hand OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Oxford Clinical Trials Research Unit
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036929
- Sponsor's protocol ID
- HOPE-e
- Acronym
- HOPE-e
- Status last verified
- Apr 2022
- First submitted
- 21 Jun 2019
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to the de-identified dataset for purposes of research other than this study, would be at the discretion of the Chief Investigator, Dr Fiona Watt and OCTRU. All participants have consented to the information collected about them from the study may be used in a de-identified form to support other research on hand osteoarthritis in the future and may in certain circumstances be passed on to other collaborators of the research team in organisations other than the University of Oxford, which may include those outside the EU and commercial organisations. Requests for the de-identified dataset generated during the current study should be made to the Chief Investigator, Dr Fiona Watt (fiona.watt@kennedy.ox.ac.uk) or OCTRU (octrutrialshub@ndorms.ox.ac.uk). Dr Fiona Watt and OCTRU will consider requests once the main results from the study have been published up until 10 Dec 2036 . All requests must relate to bone fide research into hand osteoarthritis research.
Publications
Marian IR, Goff M, Williams JAE, Gulati M, Chester-Jones M, Francis A, Watson M, Vincent TL, Woollacott S, Mackworth-Young C, Glover V, Furniss D, Gardiner M, Lamb SE, Vincent K, Barber VS, Black J, Dutton SJ, Watt FE. Hand Osteoarthritis: investigating Pain Effects of estrogen-containing therapy (HOPE-e): a protocol for a feasibility randomised placebo-controlled trial. Pilot Feasibility Stud. 2021 Jun 24;7(1):133. doi: 10.1186/s40814-021-00869-1.
PubMed 34167594
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Osteoarthritis: Investigating Pain Effects in a Randomised Placebo-controlled Feasibility Study of an Estrogen-containing Therapy
- ClinicalTrials.gov ID
- NCT04036929
- Acronym / sponsor ID
- HOPE-e / HOPE-e
- Conditions
- Hand Osteoarthritis
- Keywords
- Osteoarthritis, Hand, Hormone, Pain, Estrogen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Oxford Clinical Trials Research Unit
- Study start
- 9 May 2019 (actual)
- Primary completion
- 19 Aug 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 30 Jul 2019 (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.
Post-menopausal women aged 40-65 with symptomatic hand osteoarthritis are invited to take part in this feasibility study. The study's aim is to investigate whether it is acceptable to women with painful hand OA to take an estrogen-containing therapy, and what is the best way of collecting some of the information in order to facilitate planning a full size trial. The investigator's long-term aim is to find out whether giving estrogen-containing therapy to women after the menopause improves hand OA symptoms.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estrogen-bazedoxifene | Experimental | Drug: Estrogen-bazedoxifeneTablet, once daily for 6 months. |
| Placebo | Placebo comparator | Drug: Placebo oral tabletClosely matched tablet, once daily for 6 months. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Able to give informed written consent
- Female, aged 40-65 years old
- In those with an intact uterus: At least 12 months of spontaneous amenorrhea (without any menstrual bleeding in last 12 months) and last menstrual period not more than 10 years ago
- In those who have undergone hysterectomy or are/were using an intrauterine contraceptive device with progesterone local therapy (such as Mirena): Follicle stimulating hormone (FSH) ≥30 milli-International Units per millilitre (mIU/ml) on screening blood test AND a history of menopausal symptoms in the last 1 to 10 years, in keeping with appropriate timing of menopausal status
- Hand pain, aching or stiffness on most days in the last 3 months
Key exclusion criteria (34 listed)
- Other cause of hand pain, including inflammatory arthritis, connective tissue disorder, chronic pain or alternative clinical diagnosis such as tenosynovitis or carpal tunnel syndrome
- Pregnancy or breast feeding, or risk of this during study
- Use of one or more prohibited treatments within specified timeframe, or not willing to avoid treatment for the duration of the study:
- Presence of one or more medical contraindications to the use of systemic hormonal replacement therapy:
- Any other significant or uncontrolled disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
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 |
|---|---|---|
| Estrogen-bazedoxifeneAlso: DuaviveConjugated estrogens 0.45 mg-bazedoxifene acetate 20 mg. | Drug | Estrogen-bazedoxifene |
| Placebo oral tabletPlacebo oral tablet | Drug | Placebo |
Primary outcome
Feasibility: Rates of eligible participant identification, rates of recruitment/randomisation from different sources, retention rates
Time frame: From the date of recruitment opening until the date of recruitment closing, 1 year
Feasibility: Frequency of adverse events related to the active study medication
Time frame: Through study completion, 7 months
Feasibility: Bang's Blinding Index (likelihood of unblinding)
Time frame: Week 24
Self-complete questionnaire which assesses likelihood that participant or Investigator have become unblinded
Feasibility: Monitoring study medication compliance (via diaries)
Time frame: From randomisation to end of treatment at Week 24
Participants will be asked to record any missed doses of study medication on a paper diary which will be provided at each visit. We will ask participants to bring the diary to each study visit and any missed doses will be recorded in the Case Report Form.
12 secondary outcomes
Pain and function: Average hand pain over last 14 days (NRS 0-10)
Time frame: Collected at: Baseline, Week 4, Week 12, Week 24
Pain and function: Remote pain-rating prior to a visit (NRS 0-10)
Time frame: Collected at: Baseline, Week 4, Week 12, Week 24
Pain and function: Prevalence of joint pain elsewhere (pain manikin)
Time frame: Collected at: Baseline, Week 12, Week 24
Pain and function: Functional Index for Hand OA (FIHOA)
Time frame: Collected at: Baseline, Week 12, Week 24
Pain and function: EQ-5D-5L
Time frame: Collected at: Baseline, Week 12, Week 24
Menopause symptoms: The Menopause Specific Quality of Life Questionnaire (MENQOL)
Time frame: Collected at: Baseline, Week 12, Week 24
Menopause symptoms: Greene Climacteric Scale
Time frame: Collected at: Baseline, Week 12, Week 24
Joint appearance: Cosmesis score of Michigan Hand Questionnaire (4 questions, questions 28-31)
Time frame: Collected at: Baseline, Week 12, Week 24
Joint appearance: Investigator-recorded tender and swollen joint counts
Time frame: Collected at: Baseline, Week 12, Week 24
Joint appearance: Photographic recording of swollen hand joints
Time frame: Collected at: Baseline, Week 12, Week 24
Joint function: Jamar grip strength - average of 3 measurements
Time frame: Collected at: Baseline, Week 12, Week 24
End of Treatment questionnaire (study-specific)
Time frame: Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Background: PubMed 34167594Marian IR, Goff M, Williams JAE, Gulati M, Chester-Jones M, Francis A, Watson M, Vincent TL, Woollacott S, Mackworth-Young C, Glover V, Furniss D, Gardiner M, Lamb SE, Vincent K, Barber VS, Black J, Dutton SJ, Watt FE. Hand Osteoarthritis: investigating Pain Effects of estrogen-containing therapy (HOPE-e): a protocol for a feasibility randomised placebo-controlled trial. Pilot Feasibility Stud. 2021 Jun 24;7(1):133. doi: 10.1186/s40814-021-00869-1.
- HOPE-e study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Access to the de-identified dataset for purposes of research other than this study, would be at the discretion of the Chief Investigator, Dr Fiona Watt and OCTRU. All participants have consented to the information collected about them from the study may be used in a de-identified form to support other research on hand osteoarthritis in the future and may in certain circumstances be passed on to other collaborators of the research team in organisations other than the University of Oxford, which may include those outside the EU and commercial organisations. Requests for the de-identified dataset generated during the current study should be made to the Chief Investigator, Dr Fiona Watt (fiona.watt@kennedy.ox.ac.uk) or OCTRU (octrutrialshub@ndorms.ox.ac.uk). Dr Fiona Watt and OCTRU will consider requests once the main results from the study have been published up until 10 Dec 2036 . All requests must relate to bone fide research into hand osteoarthritis research.
Related trials for Hand Osteoarthritis
Active, not recruiting
Balneotherapy in Hand Osteoarthritis
Hand Osteoarthritis
Active, not recruitingPhase 4
Methotrexate in Erosive Inflammatory Hand Osteoarthritis
Hand Osteoarthritis, Erosive Osteoarthritis
Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Active, not recruitingPhase 2
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of STT Osteoarthritis
Osteoarthritis Hand
RecruitingPhase 2/3
Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments
Erosive Hand Osteoarthritis
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Estrogen-bazedoxifene in people with Hand Osteoarthritis, run by University of Oxford at 3 sites in United Kingdom.
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 15 inclusion and 34 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: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility: Rates of eligible participant identification, rates of recruitment/randomisation from different sources, retention rates (time frame: From the date of recruitment opening until the date of recruitment closing, 1 year). The study lists 4 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 NCT04036929, 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 21 Apr 2022.