ConstipationPhase 3NCT01474499
A Trial of Docusate Sodium and Sorbitol Rectal Solution for the in Patients With Constipation
A Phase 3 study testing Glycerine and Docusate sodium and sorbitol rectal solution in people with Constipation, run by Ferring Pharmaceuticals at 9 sites in China.
Trial summary
This study aims to evaluate the efficacy and safety of the docusate sodium and sorbitol rectal solution produced by Ferring Pharmaceutical (China) Ltd. in treating Chinese patients with constipation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Constipation
- What is being tested?
- Glycerine and Docusate sodium and sorbitol rectal solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 9 sitesChina
- Study dates
- Sep 2011to May 2012
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have signed the informed consent form and have been verbally told of the details of the trial and treatment procedures
- Is a citizen of the People's Republic of China
- Males and females aged between 18 and 65 years inclusive
- A history of constipation symptoms for at least 6 months, with occurrence of two or more of the symptoms during the 3 months before screening:
- More than 1/4 of stool classifiable as Type I or Type II on the Bristol Stool Scale;
- Sensation of incomplete evacuation at least 1/4 of the time;
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- Straining during defecation at least 1/4 of the time;
- Sensation of ano-rectal blockage or obstruction during defecation at least 1/4 of the time;
- Manual manoeuvres needed often to facilitate defecations (e.g. digital evacuation) at least 1/4 of the time;
- Fewer than 3 bowel movements per week
- No bowel movement within two days prior to randomisation
Who cannot join
- Patients who are suspected to have colorectal cancer;
- Patients showing signs of bleeding in the digestive tract or inflammatory bowel disease;
- Patients experiencing abdominal discomfort or intestinal blockage for which the cause has yet to be determined;
- Patients allergic to docusate or sorbitol;
- Patients allergic to glycerine;
- Those pregnant, breastfeeding, or with the intention of becoming pregnant, or fertile women who are not on effective birth control（i.e. an IUD (intrauterine device), oral contraceptives or other obstructive measures;
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- Severe liver damage (ALT (alanine aminotransferase), AST (aspartate transaminase), TBIL (serum total bilirubin) more than 2 times the upper limit of normal)
- Kidney function impairment (Cr (creatinine clearance rate), BUN (blood urea nitrogen) more than 1.5 times the upper limit of normal)
- Patients who have participated in any other clinical trial during the last 3 months;
- Diabetics who are currently undergoing insulin treatment;
- Patients who are unable to suspend using treatments that affect the kinetics of the digestive system in the 5 days prior randomisation. Such treatments include prokinetic drugs, erythromycin analogues, laxatives, etc;
- Other patient factor(s) (e.g. medical history, concurrent illness(es), laboratory test result(s), etc.) at Screening that in the opinion of the investigator(s) would put the trial patient at excessive risk;
- Patients who are unable to act in a legal capacity, unable to meet or perform study requirements, or are known or suspected as unable to comply with the study protocol.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Southern Medical University - Nanfang Hospital
Guangzhou, Guangdong
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
The Second Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Nanjing First Hospital
Nanjing, Jiangsu
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality
Shanghai Jiaotong University Medical School - Renji Hospital
Shanghai, Shanghai Municipality
Shanghai Jiaotong University Medical School - Ruijin Hospital
Shanghai, Shanghai Municipality
Zhongnan Hospital of Wuhan University
Wuhan, Hubei
About this study
Official title: A Multi-center, Randomized, Single-blind Clinical Study of the Comparative Safety and Efficacy of Docusate Sodium and Sorbitol Rectal Solution and Glycerine Enemas in Patients With Constipation
This study aims to evaluate the efficacy and safety of the docusate sodium and sorbitol rectal solution produced by Ferring Pharmaceutical (China) Ltd. in treating Chinese patients with constipation.
- Conditions
- Constipation
- Being tested
- Glycerine, Docusate sodium and sorbitol rectal solution
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycerineDrug
Docusate sodium and sorbitol rectal solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Docusate sodium and sorbitol rectal solution | Experimental | Not described Receives: Drug: Docusate sodium and sorbitol rectal solution |
| Glycerine | Active comparator | Not described Receives: Drug: Glycerine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall efficacy rate of the enema in treating the symptoms of constipation
Measured: Up to 30 minutes
Secondary outcomes (7)
Time from conclusion of enema administration to patient's first bowel movement
Measured: Up to 30 minutes
Amount of straining that occurs during bowel movement (normal/difficult)
Measured: Up to 30 minutes
Feeling of emptying of the rectum post bowel movement (complete/incomplete)
Measured: Up to 30 minutes
Stool form after enema treatment according to Bristol Stool Scale
Measured: Up to 30 minutes
Anal complaints (absent, anal itch, anal irritation or anal pain)
Measured: Up to 30 minutes
Abdominal pain (absent, mild, moderate, or severe)
Measured: Up to 30 minutes
Patient's overall assessment of using the enema to treat the symptoms of constipation
Measured: Up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474499
- Sponsor's protocol ID
- FE999306 CS01
- Status last verified
- Sep 2012
- First submitted
- 16 Nov 2011
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Single-blind Clinical Study of the Comparative Safety and Efficacy of Docusate Sodium and Sorbitol Rectal Solution and Glycerine Enemas in Patients With Constipation
- ClinicalTrials.gov ID
- NCT01474499
- Acronym / sponsor ID
- FE999306 CS01
- Conditions
- Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 18 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy and safety of the docusate sodium and sorbitol rectal solution produced by Ferring Pharmaceutical (China) Ltd. in treating Chinese patients with constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docusate sodium and sorbitol rectal solution | Experimental | Drug: Docusate sodium and sorbitol rectal solution |
| Glycerine | Active comparator | Drug: Glycerine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have signed the informed consent form and have been verbally told of the details of the trial and treatment procedures
- Is a citizen of the People's Republic of China
- Males and females aged between 18 and 65 years inclusive
- A history of constipation symptoms for at least 6 months, with occurrence of two or more of the symptoms during the 3 months before screening:
- No bowel movement within two days prior to randomisation
Key exclusion criteria (13 listed)
- Patients who are suspected to have colorectal cancer;
- Patients showing signs of bleeding in the digestive tract or inflammatory bowel disease;
- Patients experiencing abdominal discomfort or intestinal blockage for which the cause has yet to be determined;
- Patients allergic to docusate or sorbitol;
- Patients allergic to glycerine;
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 |
|---|---|---|
| Glycerine | Drug | Glycerine |
| Docusate sodium and sorbitol rectal solution | Drug | Docusate sodium and sorbitol rectal solution |
Primary outcome
Overall efficacy rate of the enema in treating the symptoms of constipation
Time frame: Up to 30 minutes
7 secondary outcomes
Time from conclusion of enema administration to patient's first bowel movement
Time frame: Up to 30 minutes
Amount of straining that occurs during bowel movement (normal/difficult)
Time frame: Up to 30 minutes
Feeling of emptying of the rectum post bowel movement (complete/incomplete)
Time frame: Up to 30 minutes
Stool form after enema treatment according to Bristol Stool Scale
Time frame: Up to 30 minutes
Anal complaints (absent, anal itch, anal irritation or anal pain)
Time frame: Up to 30 minutes
Abdominal pain (absent, mild, moderate, or severe)
Time frame: Up to 30 minutes
Patient's overall assessment of using the enema to treat the symptoms of constipation
Time frame: Up to 30 minutes
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 25 Sep 2012.
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glycerine and Docusate sodium and sorbitol rectal solution in people with Constipation, run by Ferring Pharmaceuticals at 9 sites 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 11 inclusion and 13 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 25 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Overall efficacy rate of the enema in treating the symptoms of constipation (time frame: Up to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2012.