ConstipationPhase 2NCT01726504
The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation
A Phase 2 study testing electro-acupuncture in people with Constipation, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
The main purpose of this study is to evaluate efficacy of electro-acupuncture for severe functional constipation compared with sham acupuncture, used as placebo; the secondary purpose is to evaluate the safety and post-treatment effect of electro-acupuncture. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Constipation
- What is being tested?
- electro-acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,075 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Dec 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meeting the diagnosis of Rome III criteria for chronic functional constipation;
- severe chronic constipation: two or fewer spontaneous complete bowel movements per week for more than 3 months;
- 18-75 years old;
- no use of medicine for constipation during the two weeks before enrollment (except rescue medication);
- no acupuncture treatment for constipation in recent 3 months;
- never joined any other trial in process in 3 months;
- volunteered to join this research and signed the informed consent.
Who cannot join
- Irritable bowel syndrome (IBS) and constipation caused by endocrine, metabolic, nervous or postoperative diseases or drugs;
- constipation accompanied by serious cardiovascular, hepatic, renal, or psychiatric disease, cognitive dysfunction or aphasia, or severe dystrophy affecting the cooperation for examination or treatment;
- pregnant women or women in lactation period
- constipation accompanied by abdominal aneurysm, hepatosplenomegaly, etcetera;
- bleeding disorders, or regular anticoagulant drug users, such as warfarin and heparin, etcetera;
- cardiac pacemaker carrier.
Trial locations and contacts
1 site in 1 country.
China1 site
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100700
About this study
Official title: The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation - a Multi-center, Randomized Controlled Trial
The main purpose of this study is to evaluate efficacy of electro-acupuncture for severe functional constipation compared with sham acupuncture, used as placebo; the secondary purpose is to evaluate the safety and post-treatment effect of electro-acupuncture.
Read the detailed description
Chronic functional constipation is a common disease. To date there has not specific therapy on chronic functional constipation. Systematic reviews indicate that acupuncture is probably effective for the disease, but the evidence is limited. Recently, we have finished a multi-center clinical trial of individualized deep electro-acupuncture (EA) for chronic functional constipation (n=460, Registration ID: NCT00508482) which preliminarily showed EA was effective.
This multi-center large-sample randomized controlled clinical trial of acupuncture for severe functional constipation is designed to confirm the efficacy and safety of EA.
This project is conducted by Chinese experts, supported by the Chinese Government. The research result is expected to provide high quality evidence of EA for chronic functional constipation.
- Conditions
- Constipation
- Being tested
- electro-acupuncture, sham electro-acupuncture
- Keywords
- chronic functional constipation, electro-acupuncture, multi-center randomized controlled trial, efficacy, safety
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electro-acupunctureDevice
Also called SDZ-V electro-acupuncture apparatus (Huatuo, made in China)
Procedure: electro-acupuncture; Points:Tianshu (ST25) Fujie(SP14), Shangjuxu (ST37).Pierced the skin, needles are inserted 30to70mm into bilateral ST25 and SP14 vertically until piercing the abdominal muscle layer.Electric stimulator is applied to bilateral ST25 and SP14 with dilatational wave, 10/50 Hz and electric current 0.1-1.0mA. The participant's abdominal muscle twitching mildly is the appropriate dose. Bilateral ST37 are inserted 25-30mm and then twirling lifting and thrusting for 3 times.Local sour and heavy feeling is appropriate dose. Steady small twirling lifting and thrusting 3 times in all. 30 min/per day/per session.During the 8 weeks treatment, the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total.
sham electro-acupunctureDevice
Also called Sham SDZ-V electro-acupuncture apparatus (Huatuo, China)
Procedure:sham electro-acupuncture;Points:Sham Tianshu(ST25),sham Fujie(SP14),sham Shangjuxu (ST37).Sham points location:20mm away from ST25,middle of Spleen and Stomach Channel;30mm from SP14,middle of Spleen and Stomach Channel; one point beside ST37,middle of Stomach and Gallbladder Channel; Performance:The needle is inserted with needle of 0.30×25mm by 3-5mm. No twirling lifting and thrusting. The electric stimulator is applied to bilateral sham ST25 and sham SP14 with dilatational wave,10/50 Hz and electric current 0.5mA.The mental wire has been cut off with a same outlook as the treatment group.The electric stimulator is looked normal but with no current output. Length of Treatment and the treatment sessions are the same as treatment group.
| Study group | Role | What they receive |
|---|---|---|
| electro-acupuncture | Experimental | 1. The electric stimulator is applied to bilateral ST25andSP14 with dilatational wave10/50 Hz and electric current0.1-1.0mA.They are given acupuncture with 0.3×50mm or 0.35×75mm needles by inserting30-70mm and twirling lifting andthrusting 3 times.Dosage:The needle arrives the abdominal muscle layer(patients feel painful and acupuncturists feel touching hard).
2. Bilateral ST37 are given conventional acupuncture with 0.30mm×40mm needles by inserting 25-30mm and twirling lifting and thrusting for 3.Dosage:Local sour and heavy feeling is the appropriate dose.
Every session lasts for 30min/day.The participants are treated continuously for 8 weeks.During 8-week treatment the first 2 weeks,5 sessions per week,and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total. Receives: Device: electro-acupuncture |
| sham electro-acupuncture | Sham comparator | 1. The electric stimulator is applied to bilateral sham ST25 and sham SP14 with dilatational wave, 10/50 Hz and electric current 0.5mA. The mental wire has been cut off with a same outlook as the treatment group. The electric stimulator is looked normal but with no current output. The needle is inserted by 3mm-5mm (the needle can be vertically fixed on the skin).
2. Bilateral ST37 are given acupuncture with 3mm-5mm (the needle can be vertically fixed on the skin).
Length of Treatment and the treatment sessions are the same as treatment group. Receives: Device: sham electro-acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment
the change number in mean weekly CSBMs during weeks 1-8 since treatment compared with baseline.
Measured: Baseline and weeks 1-8
Secondary outcomes (10)
the Percentage of Participants With Three or More Weekly CSBMs
the percentage of participants with three or more weekly CSBMs during weeks 1-8 and weeks 9-20
Measured: 1-20 weeks
Changes in Mean Weekly CSBMs During Weeks 9-20
The changed number in mean weekly average CSBMs during 9-20th weeks, compared with baseline.
Measured: Baseline and weeks 9-20
Mean Weekly SBMs During Weeks 1-8
The changed number in mean of weekly average SBMs (spontaneous bowel movement) during 8-week treatment, compared with baseline.
Measured: Baseline and weeks 1-8
Mean Scores for Stool Consistency and Straining During Weeks 1-8
average weekly stool consistency (Bristol Stool Scale) assessment of self-defecation during the 1-8weeks of treatment,compared with baseline. Bristol Stool Scale including 7-type, scored by 1 to 7 respectively.Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (passed easily); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces. Entirely liquid. Type 3, 4 are normal.
Measured: Baseline and weeks 1-8
Change of Average Weekly Degree of Difficulty in Defecation From Baseline
The degree of straining during self-defecation: The severity of straining is graded using a 4-point ordinal scale.
0 = not at all
- = more straining than not
- = a great deal
- = an extreme amount, need finger manipulation to defecate average weekly degree of difficulty in self-defecation during 1-8weeks,compared with baseline
Measured: Baseline and weeks 1-8
Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL)
Patient-Assessment of Constipation Quality Of Life(PAC-QOL) ranges are 28-140,and higher values represent a worse outcome.Subscales are summed to compute the total score. The changed score of PAC-QOL at week 8, compared with baseline.
Measured: baseline and the end of 8th week
Number of Participants With Adverse Events Related to Acupuncture
Measured: 1-8 weeks
Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used
Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40-60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements.
Measured: 1-20 weeks
The Number of Participants Using Rescue Medicine for Constipation
Measured: 1-20 weeks
Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used
Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40-60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements.
Measured: 1-20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2014
- Study completionDec 2014
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 ConstipationStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,075 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Responsible party
- Principal investigator, Liu Baoyan, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Baoyan Liu, Master, Principal investigator, Vice President of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726504
- Sponsor's protocol ID
- 2012BAI24B01
- Status last verified
- Jan 2016
- First submitted
- 30 Oct 2012
- Last updated
- 22 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wang Y, Liu Y, Zhou K, Bauer BA, Liu B, Su T, Mo Q, Liu Z. The duration of acupuncture effects and its associated factors in chronic severe functional constipation: secondary analysis of a randomized controlled trial. Ther Adv Gastroenterol. 2019 Oct 9;12:1756284819881859. doi: 10.1177/1756284819881859. eCollection 2019.
PubMed 31636713Liu Z, Yan S, Wu J, He L, Li N, Dong G, Fang J, Fu W, Fu L, Sun J, Wang L, Wang S, Yang J, Zhang H, Zhang J, Zhao J, Zhou W, Zhou Z, Ai Y, Zhou K, Liu J, Xu H, Cai Y, Liu B. Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial. Ann Intern Med. 2016 Dec 6;165(11):761-769. doi: 10.7326/M15-3118. Epub 2016 Sep 13.
PubMed 27618593Liu Z, Liu J, Zhao Y, Cai Y, He L, Xu H, Zhou X, Yan S, Lao L, Liu B. The efficacy and safety study of electro-acupuncture for severe chronic functional constipation: study protocol for a multicenter, randomized, controlled trial. Trials. 2013 Jun 15;14:176. doi: 10.1186/1745-6215-14-176.
PubMed 23768191
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation - a Multi-center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01726504
- Acronym / sponsor ID
- 2012BAI24B01
- Conditions
- Constipation
- Keywords
- chronic functional constipation, electro-acupuncture, multi-center randomized controlled trial, efficacy, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,075 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Study start
- Oct 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Nov 2012 (estimated)
- Results
- Posted 23 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate efficacy of electro-acupuncture for severe functional constipation compared with sham acupuncture, used as placebo; the secondary purpose is to evaluate the safety and post-treatment effect of electro-acupuncture.
Detailed description
Chronic functional constipation is a common disease. To date there has not specific therapy on chronic functional constipation. Systematic reviews indicate that acupuncture is probably effective for the disease, but the evidence is limited. Recently, we have finished a multi-center clinical trial of individualized deep electro-acupuncture (EA) for chronic functional constipation (n=460, Registration ID: NCT00508482) which preliminarily showed EA was effective.
This multi-center large-sample randomized controlled clinical trial of acupuncture for severe functional constipation is designed to confirm the efficacy and safety of EA.
This project is conducted by Chinese experts, supported by the Chinese Government. The research result is expected to provide high quality evidence of EA for chronic functional constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electro-acupuncture | Experimental | Device: electro-acupuncture1. The electric stimulator is applied to bilateral ST25andSP14 with dilatational wave10/50 Hz and electric current0.1-1.0mA.They are given acupuncture with 0.3×50mm or 0.35×75mm needles by inserting30-70mm and twirling lifting andthrusting 3 times.Dosage:The needle arrives the abdominal muscle layer(patients feel painful and acupuncturists feel touching hard). 2. Bilateral ST37 are given conventional acupuncture with 0.30mm×40mm needles by inserting 25-30mm and twirling lifting and thrusting for 3.Dosage:Local sour and heavy feeling is the appropriate dose. Every session lasts for 30min/day.The participants are treated continuously for 8 weeks.During 8-week treatment the first 2 weeks,5 sessions per week,and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total. |
| sham electro-acupuncture | Sham comparator | Device: sham electro-acupuncture1. The electric stimulator is applied to bilateral sham ST25 and sham SP14 with dilatational wave, 10/50 Hz and electric current 0.5mA. The mental wire has been cut off with a same outlook as the treatment group. The electric stimulator is looked normal but with no current output. The needle is inserted by 3mm-5mm (the needle can be vertically fixed on the skin). 2. Bilateral ST37 are given acupuncture with 3mm-5mm (the needle can be vertically fixed on the skin). Length of Treatment and the treatment sessions are the same as treatment group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- meeting the diagnosis of Rome III criteria for chronic functional constipation;
- severe chronic constipation: two or fewer spontaneous complete bowel movements per week for more than 3 months;
- 18-75 years old;
- no use of medicine for constipation during the two weeks before enrollment (except rescue medication);
- no acupuncture treatment for constipation in recent 3 months;
Key exclusion criteria (6 listed)
- Irritable bowel syndrome (IBS) and constipation caused by endocrine, metabolic, nervous or postoperative diseases or drugs;
- constipation accompanied by serious cardiovascular, hepatic, renal, or psychiatric disease, cognitive dysfunction or aphasia, or severe dystrophy affecting the cooperation for examination or treatment;
- pregnant women or women in lactation period
- constipation accompanied by abdominal aneurysm, hepatosplenomegaly, etcetera;
- bleeding disorders, or regular anticoagulant drug users, such as warfarin and heparin, etcetera;
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-acupunctureAlso: SDZ-V electro-acupuncture apparatus (Huatuo, made in China)Procedure: electro-acupuncture; Points:Tianshu (ST25) Fujie(SP14), Shangjuxu (ST37).Pierced the skin, needles are inserted 30to70mm into bilateral ST25 and SP14 vertically until piercing the abdominal muscle layer.Electric stimulator is applied to bilateral ST25 and SP14 with dilatational wave, 10/50 Hz and electric current 0.1-1.0mA. The participant's abdominal muscle twitching mildly is the appropriate dose. Bilateral ST37 are inserted 25-30mm and then twirling lifting and thrusting for 3 times.Local sour and heavy feeling is appropriate dose. Steady small twirling lifting and thrusting 3 times in all. 30 min/per day/per session.During the 8 weeks treatment, the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total. | Device | electro-acupuncture |
| sham electro-acupunctureAlso: Sham SDZ-V electro-acupuncture apparatus (Huatuo, China)Procedure:sham electro-acupuncture;Points:Sham Tianshu(ST25),sham Fujie(SP14),sham Shangjuxu (ST37).Sham points location:20mm away from ST25,middle of Spleen and Stomach Channel;30mm from SP14,middle of Spleen and Stomach Channel; one point beside ST37,middle of Stomach and Gallbladder Channel; Performance:The needle is inserted with needle of 0.30×25mm by 3-5mm. No twirling lifting and thrusting. The electric stimulator is applied to bilateral sham ST25 and sham SP14 with dilatational wave,10/50 Hz and electric current 0.5mA.The mental wire has been cut off with a same outlook as the treatment group.The electric stimulator is looked normal but with no current output. Length of Treatment and the treatment sessions are the same as treatment group. | Device | sham electro-acupuncture |
Primary outcome
the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment
Time frame: Baseline and weeks 1-8
the change number in mean weekly CSBMs during weeks 1-8 since treatment compared with baseline.
10 secondary outcomes
the Percentage of Participants With Three or More Weekly CSBMs
Time frame: 1-20 weeks
Changes in Mean Weekly CSBMs During Weeks 9-20
Time frame: Baseline and weeks 9-20
Mean Weekly SBMs During Weeks 1-8
Time frame: Baseline and weeks 1-8
Mean Scores for Stool Consistency and Straining During Weeks 1-8
Time frame: Baseline and weeks 1-8
Change of Average Weekly Degree of Difficulty in Defecation From Baseline
Time frame: Baseline and weeks 1-8
Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL)
Time frame: baseline and the end of 8th week
Number of Participants With Adverse Events Related to Acupuncture
Time frame: 1-8 weeks
Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used
Time frame: 1-20 weeks
The Number of Participants Using Rescue Medicine for Constipation
Time frame: 1-20 weeks
Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used
Time frame: 1-20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31636713Wang Y, Liu Y, Zhou K, Bauer BA, Liu B, Su T, Mo Q, Liu Z. The duration of acupuncture effects and its associated factors in chronic severe functional constipation: secondary analysis of a randomized controlled trial. Ther Adv Gastroenterol. 2019 Oct 9;12:1756284819881859. doi: 10.1177/1756284819881859. eCollection 2019.
- Derived from this study: PubMed 27618593Liu Z, Yan S, Wu J, He L, Li N, Dong G, Fang J, Fu W, Fu L, Sun J, Wang L, Wang S, Yang J, Zhang H, Zhang J, Zhao J, Zhou W, Zhou Z, Ai Y, Zhou K, Liu J, Xu H, Cai Y, Liu B. Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial. Ann Intern Med. 2016 Dec 6;165(11):761-769. doi: 10.7326/M15-3118. Epub 2016 Sep 13.
- Derived from this study: PubMed 23768191Liu Z, Liu J, Zhao Y, Cai Y, He L, Xu H, Zhou X, Yan S, Lao L, Liu B. The efficacy and safety study of electro-acupuncture for severe chronic functional constipation: study protocol for a multicenter, randomized, controlled trial. Trials. 2013 Jun 15;14:176. doi: 10.1186/1745-6215-14-176.
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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.
Baoyan Liu, Master principal investigator
Vice President of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing electro-acupuncture in people with Constipation, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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 6 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 22 Feb 2016. 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 China. 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 23 Nov 2015). 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?
the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment (time frame: Baseline and weeks 1-8). 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 NCT01726504, 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 22 Feb 2016.