Fecal IncontinencePhase 1/2NCT01380132
Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence
A Phase 1/2 study testing Anal injection of Nasha Dx in people with Fecal Incontinence, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether anorectal application of Nasha Dx is safe and effective for treatment of anal incontinence. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Anal injection of Nasha Dx
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2004to May 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Incontinence to loose or solid stool at least once weekly (Millers incontinence score 6-12).
- Age 18-80
- Available for follow-up for the duration of the study
- Written informed consent.
Who cannot join
- Sphincter defect visible on anal ultrasound.
- Pregnancy.
- Rectal prolapse or inflammatory bowel disease.
- Recent (within 6 months) anal surgery except for haemorrhoids.
- Anorectal sepsis.
- Anticoagulant medication or bleeding diathesis.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether anorectal application of Nasha Dx is safe and effective for treatment of anal incontinence.
Read the detailed description
Patients not fully improved after 1:st injection were offered reinjection after 4-6 weeks.
- Conditions
- Fecal Incontinence
- Being tested
- Anal injection of Nasha Dx
- Keywords
- Fecal incontinence, Treatment, Surgery
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anal injection of Nasha DxProcedure or surgery
Also called Solesta
Submucous injection of Nasha Dx 5-10 mm above dentate line
| Study group | Role | What they receive |
|---|---|---|
| Anal injection of Nasha Dx | Experimental | Not described Receives: Procedure: Anal injection of Nasha Dx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response as measured by a 50% reduction in no of incontinence episodes.
Measured: One year posttreatment
Secondary outcomes (9)
Adverse events
Measured: One year posttreatment
Global assessment
Graded by the patient as excellent, good, fair or poor
Measured: One year posttreatment
Change in incontinence episodes
Measured relative baseline based on a 4-week diary
Measured: One year posttreatment
Quality of life
Measured with a validated bowel function questionnaire
Measured: One year posttreatment
Adverse events
Measured: Two years posttreatment
Global assessment
Graded by the patient as excellent, good, fair or poor
Measured: Two years posttreatment
Change in incontinence episodes
Measured relative baseline based on a 4-week diary
Measured: Two years posttreatment
Quality of life
Measured with a validated bowel function questionnaire
Measured: Two years posttreatment
Treatment response as measured by a 50% reduction in no of incontinence episodes.
Measured: Two years posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startFeb 2004
- Primary completionJan 2009
- Study completionMay 2009
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 Fecal IncontinenceStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Investigators
- Wilhelm JR Graf, Prof., Principal investigator, Inst of Surgical Sciences, Uppsala university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380132
- Sponsor's protocol ID
- Nasha Dx Pilot study
- Other IDs
- 03 464
- Status last verified
- Feb 2010
- First submitted
- 21 Jun 2011
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Danielson J, Karlbom U, Sonesson AC, Wester T, Graf W. Submucosal injection of stabilized nonanimal hyaluronic acid with dextranomer: a new treatment option for fecal incontinence. Dis Colon Rectum. 2009 Jun;52(6):1101-6. doi: 10.1007/DCR.0b013e31819f5cbf.
PubMed 19581853
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence
- ClinicalTrials.gov ID
- NCT01380132
- Acronym / sponsor ID
- Nasha Dx Pilot study
- Conditions
- Fecal Incontinence
- Keywords
- Fecal incontinence, Treatment, Surgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- Feb 2004
- Primary completion
- Jan 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 27 Jun 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.
The purpose of this study is to determine whether anorectal application of Nasha Dx is safe and effective for treatment of anal incontinence.
Detailed description
Patients not fully improved after 1:st injection were offered reinjection after 4-6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anal injection of Nasha Dx | Experimental | Procedure: Anal injection of Nasha Dx |
Who may qualify
- Ages
- 18 to 80 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Incontinence to loose or solid stool at least once weekly (Millers incontinence score 6-12).
- Age 18-80
- Available for follow-up for the duration of the study
- Written informed consent.
Key exclusion criteria (6 listed)
- Sphincter defect visible on anal ultrasound.
- Pregnancy.
- Rectal prolapse or inflammatory bowel disease.
- Recent (within 6 months) anal surgery except for haemorrhoids.
- Anorectal sepsis.
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 |
|---|---|---|
| Anal injection of Nasha DxAlso: SolestaSubmucous injection of Nasha Dx 5-10 mm above dentate line | Procedure or surgery | Anal injection of Nasha Dx |
Primary outcome
Treatment response as measured by a 50% reduction in no of incontinence episodes.
Time frame: One year posttreatment
9 secondary outcomes
Adverse events
Time frame: One year posttreatment
Global assessment
Time frame: One year posttreatment
Change in incontinence episodes
Time frame: One year posttreatment
Quality of life
Time frame: One year posttreatment
Adverse events
Time frame: Two years posttreatment
Global assessment
Time frame: Two years posttreatment
Change in incontinence episodes
Time frame: Two years posttreatment
Quality of life
Time frame: Two years posttreatment
Treatment response as measured by a 50% reduction in no of incontinence episodes.
Time frame: Two years posttreatment
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 28 Jun 2011.
- Results publication: PubMed 19581853Danielson J, Karlbom U, Sonesson AC, Wester T, Graf W. Submucosal injection of stabilized nonanimal hyaluronic acid with dextranomer: a new treatment option for fecal incontinence. Dis Colon Rectum. 2009 Jun;52(6):1101-6. doi: 10.1007/DCR.0b013e31819f5cbf.
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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.
Wilhelm JR Graf, Prof. principal investigator
Inst of Surgical Sciences, Uppsala university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Anal injection of Nasha Dx in people with Fecal Incontinence, run by Uppsala University Hospital at 1 site in Sweden.
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 4 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 28 Jun 2011. 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 Sweden. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study 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?
Treatment response as measured by a 50% reduction in no of incontinence episodes. (time frame: One year posttreatment). 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 NCT01380132, 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 28 Jun 2011.