Polycystic Kidney, Autosomal DominantPhase 2TAMENCT02656017
Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney Disease
A Phase 2 study testing Metformin in people with Polycystic Kidney, Autosomal Dominant, run by Kyongtae Ty Bae, M.D., Ph.D. at 2 sites in United States.
Trial summary
This study will test to see if metformin is safe and if it is tolerated compared to placebo in adult Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients with beginning stages of chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Polycystic Kidney, Autosomal Dominant
- What is being tested?
- Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jun 2016to 7 Dec 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject has Autosomal Dominant Polycystic Kidney Disease; Subject is fluent in English
Who cannot join
- Subject is not on active military duty; Subject is not currently participating in another clinical trial; Subject's current GFR is not <50 cc/min/1.73m2; Subject does not have diabetes; Subject does not have a systemic disease other than hypertension and PKD; Subject does not have a solitary kidney; Subject does not have an allergy or intolerance to metformin; Subject is not pregnant or lactating or intending to become pregnant within the next three years; Subject does not have an unstable or unclipped cerebral aneurysm; Subject does not have active coronary artery disease; Subject does not have an MRI incompatible device/implant; Subject does not have severe claustrophobia; Subject has not had any solid organ transplant; Subject does not have a Vitamin B12 deficiency; Subject does not currently take any medications that interact with metformin, such as nifedipine, furosemide, cationic drugs (amiloride, ranitidine, triamterene digoxin, procainamide, quinidine, vancomycin, trimethoprim); Subject does not currently take nor has taken (within 2 weeks) the drug tolvaptan (Jynarque or Samsca)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
Tufts Medical Center
Boston, Massachusetts, 02111
About this study
This study will test to see if metformin is safe and if it is tolerated compared to placebo in adult Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients with beginning stages of chronic kidney disease. We will also measure its effect on progression of kidney disease as reflected in the kidney size and the kidney function, along with its effect on kidney pain and quality of life.
Read the detailed description
There is growing evidence that metformin, a drug widely used for the treatment of type 2 diabetes and polycystic ovary syndrome, may serve as a novel therapy for individuals in the early stages of Autosomal Dominant Polycystic Kidney Disease ADPKD by activating the metabolic sensor AMP-activated protein kinase (AMPK). AMPK is activated under conditions of metabolic and other cellular stresses. Through its actions on downstream mediators, AMPK activation during low energy states decreases cellular energy consumption while stimulating energy generating pathways. It has been shown that AMPK phosphorylates and inhibits cystic fibrosis transmembrane conductance regulator (CFTR), thus suppressing epithelial fluid and electrolyte secretion. Similarly, AMPK phosphorylates the tuberin protein, leading to indirect inhibition of the mTOR pathway. Thus, AMPK inhibits both CFTR and mTOR, suggesting that targeted activation of this kinase by metformin may provide a therapeutic benefit in ADPKD. It has been shown that metformin treatment of kidney epithelial cells leads to stimulation of AMPK and subsequent inhibition of both mTOR and CFTR activity. It has also been shown that metformin slows cystogenesis in animal models of PKD, supporting the potential of this drug in ADPKD treatment.
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Being tested
- Metformin, Placebo
- Keywords
- kidney disease, polycystic kidney disease, autosomal dominant kidney disease, kidney cysts, PKD
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant, Kidney Diseases, Polycystic Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage, Metformin hydrochloride
Monitoring of tolerability and symptoms.
PlaceboOther
Monitoring of tolerability and symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Participants will be started on 500 mg of metformin once daily, with the following scheduled dose titrations:
* Increase to 500mg twice daily at week 2
* Increase to 1000mg qAM, 500mg qPM at week 4
* Increase to 1000mg twice daily at week 6 for the duration of their participation (26 months).
* Increased titrations based on tolerability Receives: Drug: Metformin |
| Placebo | Placebo comparator | Participants will be started on 500 mg of placebo once daily, with the following scheduled dose titrations:
* Increase to 500mg twice daily at week 2
* Increase to 1000mg qAM, 500mg qPM at week 4
* Increase to 1000mg twice daily at week 6 for the duration of their participation (26 months).
* Increased titrations based on tolerability Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Gastrointestinal Symptoms Rating Scale (GSRS) to 24 Months
GSRS is a widely used, validated 15-item questionnaire used to assess GI symptom burden (minimum, maximum: 1, 7, where higher mean score is worse outcome).
Mean change to 24 months, estimated with a repeated measures analysis (baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months) using a linear mixed model.
Measured: Baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months
Drug Tolerability
Tolerability was based on the first visit a participant responded no to the following question "Can you tolerate this dose of study drug the rest of your life?", which was asked at baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months.
Measured: Baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months
Rate of Serious Adverse Events (SAE)
Serious adverse events (SAE) occurring from the time a participant signs the informed consent (at the screening visit) until the end of the study, meeting 1 or more of the criteria of: 1) Resulting in death, 2) Non-elective hospitalization, 3) Life threatening (if patient continued on study drug would result in death), 4) Harming or disabling persistently or permanently , 5) Exceeding the nature, severity or frequency of risk described in the protocol or 6) Resulting in congenital anomaly.
Measured: 26 months
Secondary outcomes (11)
Quality of Life Physical Component
Short Form-36 Quality of Life Physical Component Summary (SF-36 PCS) ranges from 0 (worst possible outcome) to 100 (best possible outcome).
Mean change to 24 months, estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a linear mixed model.
Measured: Baseline, 1 month, 3 months and every 3 months thereafter to 24 months
Quality of Life Mental Component
Short Form-36 Quality of Life Mental Component Summary (SF-36 MCS) ranges from 0 (worst possible outcome) to 100 (best possible outcome).
Mean change to 24 months, estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a linear mixed model.
Measured: Baseline, 1 month, 3 months and every 3 months thereafter to 24 months
Back Pain Frequency Over the Past 3 Months Since Last Visit
Odds ratio (OR) per month of back pain Often, Usually, or Always (vs. Never, Rarely, Sometimes) estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a generalized linear mixed model.
Measured: Baseline, 1 month, 3 months and every 3 months thereafter to 24 months
Estimated Glomerular Filtration Rate (eGFR)
Mean change to 24 months, estimated with a repeated measures analysis (baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months) using a linear mixed model.
Measured: Baseline, 2 weeks, and 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months
Total Kidney Volume From Magnetic Resonance Imaging
Annual percent change of height adjusted and natural log transformed total kidney volume [ln(htTKV)] was estimated with a linear mixed model.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Total Kidney Cyst Volume From Magnetic Resonance Imaging
Annual percent change of height adjusted and natural log transformed total kidney cyst volume [ln(htTKCV)] was estimated with a linear mixed model.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Liver Volume From Magnetic Resonance Imaging
Annual percent change of height adjusted and natural log transformed liver volume [ln(htLV)] was estimated with a linear mixed model.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Liver Cyst Volume From Magnetic Resonance Imaging
Annual percent change of height adjusted and natural log transformed liver cyst volume [ln(htLCV)] was estimated with a linear mixed model.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Frequency Abdominal Fullness Interfered With Ability to Perform Usual Physical Activity Over the Past 3 Months Since Last Visit.
Odds ratio (OR) per month of abdominal fullness interfered Often, Usually, or Always (vs. Never, Rarely, Sometimes) estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a generalized linear mixed model.
Measured: Baseline, 1 month, 3 months and every 3 months thereafter to 24 months
Interference of Pain With Sleep Over the Past 3 Months Since Last Visit
Odds ratio (OR) per month of pain interfered with sleep Quite a bit or Extremely (vs. Not at all, A little bit, Moderately) estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a generalized linear mixed model.
Measured: Baseline, 1 month, 3 months and every 3 months thereafter to 24 months
Interference of Pain With Strenuous Physical Activity Over the Past 3 Months Since Last Visit
Odds ratio (OR) per month of pain interfered with strenuous physical activity Quite a bit or Extremely (vs. Not at all, A little bit, Moderately) estimated with a repeated measures analysis (baseline, 1 month, 3 months and every 3 months thereafter to 24 months) using a generalized linear mixed model.
Measured: Baseline, 1 month, 3 months and every 3 months thereafter to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study start27 Jun 2016
- Primary completion7 Dec 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Polycystic Kidney, Autosomal DominantStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyongtae Ty Bae, M.D., Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts Medical Center, University of Maryland, Baltimore, University of Southern California, United States Department of Defense
- Responsible party
- Sponsor-investigator, Kyongtae Ty Bae, M.D., Ph.D., University of Pittsburgh
- Investigators
- Kyongtae Bae, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656017
- Sponsor's protocol ID
- PRO15060422
- Other IDs
- CDMRP-PR141606
- Acronym
- TAME
- Status last verified
- Aug 2022
- First submitted
- 23 Dec 2015
- Last updated
- 9 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
PubMed 39356039El-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.pub2.
PubMed 38837240Seliger SL, Watnick T, Althouse AD, Perrone RD, Abebe KZ, Hallows KR, Miskulin DC, Bae KT. Baseline Characteristics and Patient-Reported Outcomes of ADPKD Patients in the Multicenter TAME-PKD Clinical Trial. Kidney360. 2020 Dec 31;1(12):1363-1372. doi: 10.34067/KID.0004002020.
PubMed 33768205
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT02656017
- Acronym / sponsor ID
- TAME / PRO15060422
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Keywords
- kidney disease, polycystic kidney disease, autosomal dominant kidney disease, kidney cysts, PKD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Kyongtae Ty Bae, M.D., Ph.D.University, hospital or other
- Collaborators
- Tufts Medical Center, University of Maryland, Baltimore, University of Southern California, United States Department of Defense
- Study start
- 27 Jun 2016 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Posted 9 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test to see if metformin is safe and if it is tolerated compared to placebo in adult Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients with beginning stages of chronic kidney disease. We will also measure its effect on progression of kidney disease as reflected in the kidney size and the kidney function, along with its effect on kidney pain and quality of life.
Detailed description
There is growing evidence that metformin, a drug widely used for the treatment of type 2 diabetes and polycystic ovary syndrome, may serve as a novel therapy for individuals in the early stages of Autosomal Dominant Polycystic Kidney Disease ADPKD by activating the metabolic sensor AMP-activated protein kinase (AMPK). AMPK is activated under conditions of metabolic and other cellular stresses. Through its actions on downstream mediators, AMPK activation during low energy states decreases cellular energy consumption while stimulating energy generating pathways. It has been shown that AMPK phosphorylates and inhibits cystic fibrosis transmembrane conductance regulator (CFTR), thus suppressing epithelial fluid and electrolyte secretion. Similarly, AMPK phosphorylates the tuberin protein, leading to indirect inhibition of the mTOR pathway. Thus, AMPK inhibits both CFTR and mTOR, suggesting that targeted activation of this kinase by metformin may provide a therapeutic benefit in ADPKD. It has been shown that metformin treatment of kidney epithelial cells leads to stimulation of AMPK and subsequent inhibition of both mTOR and CFTR activity. It has also been shown that metformin slows cystogenesis in animal models of PKD, supporting the potential of this drug in ADPKD treatment.
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 |
|---|---|---|
| Metformin | Experimental | Drug: MetforminParticipants will be started on 500 mg of metformin once daily, with the following scheduled dose titrations: * Increase to 500mg twice daily at week 2 * Increase to 1000mg qAM, 500mg qPM at week 4 * Increase to 1000mg twice daily at week 6 for the duration of their participation (26 months). * Increased titrations based on tolerability |
| Placebo | Placebo comparator | Other: PlaceboParticipants will be started on 500 mg of placebo once daily, with the following scheduled dose titrations: * Increase to 500mg twice daily at week 2 * Increase to 1000mg qAM, 500mg qPM at week 4 * Increase to 1000mg twice daily at week 6 for the duration of their participation (26 months). * Increased titrations based on tolerability |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subject has Autosomal Dominant Polycystic Kidney Disease; Subject is fluent in English
Key exclusion criteria (1 listed)
- Subject is not on active military duty; Subject is not currently participating in another clinical trial; Subject's current GFR is not <50 cc/min/1.73m2; Subject does not have diabetes; Subject does not have a systemic disease other than hypertension and PKD; Subject does not have a solitary kidney; Subject does not have an allergy or intolerance to metformin; Subject is not pregnant or lactating or intending to become pregnant within the next three years; Subject does not have an unstable or unclipped cerebral aneurysm; Subject does not have active coronary artery disease; Subject does not have an MRI incompatible device/implant; Subject does not have severe claustrophobia; Subject has not had any solid organ transplant; Subject does not have a Vitamin B12 deficiency; Subject does not currently take any medications that interact with metformin, such as nifedipine, furosemide, cationic drugs (amiloride, ranitidine, triamterene digoxin, procainamide, quinidine, vancomycin, trimethoprim); Subject does not currently take nor has taken (within 2 weeks) the drug tolvaptan (Jynarque or Samsca)
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 |
|---|---|---|
| MetforminAlso: Glucophage, Metformin hydrochlorideMonitoring of tolerability and symptoms. | Drug | Metformin |
| PlaceboMonitoring of tolerability and symptoms. | Other | Placebo |
Primary outcome
Change in the Gastrointestinal Symptoms Rating Scale (GSRS) to 24 Months
Time frame: Baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months
GSRS is a widely used, validated 15-item questionnaire used to assess GI symptom burden (minimum, maximum: 1, 7, where higher mean score is worse outcome). Mean change to 24 months, estimated with a repeated measures analysis (baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months) using a linear mixed model.
Drug Tolerability
Time frame: Baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months
Tolerability was based on the first visit a participant responded no to the following question "Can you tolerate this dose of study drug the rest of your life?", which was asked at baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months.
Rate of Serious Adverse Events (SAE)
Time frame: 26 months
Serious adverse events (SAE) occurring from the time a participant signs the informed consent (at the screening visit) until the end of the study, meeting 1 or more of the criteria of: 1) Resulting in death, 2) Non-elective hospitalization, 3) Life threatening (if patient continued on study drug would result in death), 4) Harming or disabling persistently or permanently , 5) Exceeding the nature, severity or frequency of risk described in the protocol or 6) Resulting in congenital anomaly.
11 secondary outcomes
Quality of Life Physical Component
Time frame: Baseline, 1 month, 3 months and every 3 months thereafter to 24 months
Quality of Life Mental Component
Time frame: Baseline, 1 month, 3 months and every 3 months thereafter to 24 months
Back Pain Frequency Over the Past 3 Months Since Last Visit
Time frame: Baseline, 1 month, 3 months and every 3 months thereafter to 24 months
Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline, 2 weeks, and 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months
Total Kidney Volume From Magnetic Resonance Imaging
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Total Kidney Cyst Volume From Magnetic Resonance Imaging
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Liver Volume From Magnetic Resonance Imaging
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Liver Cyst Volume From Magnetic Resonance Imaging
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Frequency Abdominal Fullness Interfered With Ability to Perform Usual Physical Activity Over the Past 3 Months Since Last Visit.
Time frame: Baseline, 1 month, 3 months and every 3 months thereafter to 24 months
Interference of Pain With Sleep Over the Past 3 Months Since Last Visit
Time frame: Baseline, 1 month, 3 months and every 3 months thereafter to 24 months
Interference of Pain With Strenuous Physical Activity Over the Past 3 Months Since Last Visit
Time frame: Baseline, 1 month, 3 months and every 3 months thereafter to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39356039St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
- Derived from this study: PubMed 38837240El-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.pub2.
- Derived from this study: PubMed 33768205Seliger SL, Watnick T, Althouse AD, Perrone RD, Abebe KZ, Hallows KR, Miskulin DC, Bae KT. Baseline Characteristics and Patient-Reported Outcomes of ADPKD Patients in the Multicenter TAME-PKD Clinical Trial. Kidney360. 2020 Dec 31;1(12):1363-1372. doi: 10.34067/KID.0004002020.
- Individual participant dataSharing planned: No
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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.
Kyongtae Bae, MD, PhD principal investigator
University of Pittsburgh
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 Metformin in people with Polycystic Kidney, Autosomal Dominant, run by Kyongtae Ty Bae, M.D., Ph.D. 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 1 inclusion and 1 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 9 Aug 2022. 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?
Yes. Results are posted in the registry (first posted 9 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 the Gastrointestinal Symptoms Rating Scale (GSRS) to 24 Months (time frame: Baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months). The study lists 3 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 NCT02656017, which also lists 3 linked publications.
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 9 Aug 2022.