Crohn's DiseasePhase 3Fibrin glueNCT00723047
Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial
A Phase 3 study testing Fibrin glue injection in fistula in people with Crohn's Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 14 sites in 2 countries.
Trial summary
This multicenter, randomized, controlled trial was conducted by the Groupe d'Etude Thérapeutique des Affections Inflammatoires du tube Digestif (GETAID) to evaluate the efficacy and safety of the injection of fibrin glue in perianal fistulas tracts of patients with CD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Fibrin glue injection in fistula
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Nov 2003to Aug 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years old
- CD confirmed by endoscopy and histology.
- CDAI should be 250 or less
- at least one perianal fistula (between anus or low rectum and perineum, vulva or vagina) draining for more than 2 months duration
Who cannot join
- treatment with an anti-TNF agent or with ciclosporin or tacrolimus within the last 3 months
- presence of a perianal abscess (>1cm) assessed by magnetic resonance imaging (MRI) or endo-anal ultrasonography performed within the last month,
- presence of anal or rectal stenosis,
- surgery during the previous month (except seton removal),
- previous fibrin glue injection,
- pregnancy.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
France13 sites
Beaujon Hospital
Clichy, 92110
Louis Mourrier Hospital
Colombes, 92700
CHRU Lille
Lille
Marseille North Hospital
Marseille, 13915
Nice University Hospital
Nice, 06202
Hopital St Louis
Paris, 75010
Lariboisiere Hospital
Paris, 75010
Georges Pompidou European Hospital
Paris, 75015
Bichat Hospital
Paris, 75018
Lyon Sud University Hospital
Pierre-Bénite, 69495
Pontchaillou University Hospital
Rennes, 35033
Rouen University Hospital
Rouen, 76031
Trousseau University Hospital
Tours, 37044
About this study
This multicenter, randomized, controlled trial was conducted by the Groupe d'Etude Thérapeutique des Affections Inflammatoires du tube Digestif (GETAID) to evaluate the efficacy and safety of the injection of fibrin glue in perianal fistulas tracts of patients with CD. The institutional Independent Ethics Committee of Marseille, France and of Liège, Belgium approved the protocol for each participating centers. Recruitment took place at 12 sites (11 in France and 1 in Belgium)
- Conditions
- Crohn's Disease
- Being tested
- Fibrin glue injection in fistula
- Keywords
- Patients, CD complicated, least, One perianal fistula, Draining, 2 months duration
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin glue injection in fistulaProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: Fibrin glue injection in fistula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Remission
Clinical remission was defined as
- the absence of any draining by fistula openings occurring spontaneously or after gentle finger compression ,
- the absence of perianal pain
- and the absence of perianal abscess.
Measured: 8 weeks after inclusion
Secondary outcomes (2)
Early Clinical Remission
Measured: 4 weeks after Inclusion
Occurrence of perianal abcess
Measured: During whole study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startNov 2003
- Primary completionJun 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Sponsor type
- University, hospital or other
- Collaborators
- Nycomed, Société Nationale Française de Gastroentérologie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723047
- Sponsor's protocol ID
- GETAID 2003-1
- Acronym
- Fibrin glue
- Status last verified
- Sep 2011
- First submitted
- 25 Jul 2008
- Last updated
- 5 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Hellers G, Bergstrand O, Ewerth S, Holmstrom B. Occurrence and outcome after primary treatment of anal fistulae in Crohn's disease. Gut. 1980 Jun;21(6):525-7. doi: 10.1136/gut.21.6.525.
PubMed 7429313Schwartz DA, Loftus EV Jr, Tremaine WJ, Panaccione R, Harmsen WS, Zinsmeister AR, Sandborn WJ. The natural history of fistulizing Crohn's disease in Olmsted County, Minnesota. Gastroenterology. 2002 Apr;122(4):875-80. doi: 10.1053/gast.2002.32362.
PubMed 11910338Schwartz DA, Pemberton JH, Sandborn WJ. Diagnosis and treatment of perianal fistulas in Crohn disease. Ann Intern Med. 2001 Nov 20;135(10):906-18. doi: 10.7326/0003-4819-135-10-200111200-00011.
PubMed 11712881Bernstein LH, Frank MS, Brandt LJ, Boley SJ. Healing of perineal Crohn's disease with metronidazole. Gastroenterology. 1980 Aug;79(2):357-65.
PubMed 7399243Present DH, Korelitz BI, Wisch N, Glass JL, Sachar DB, Pasternack BS. Treatment of Crohn's disease with 6-mercaptopurine. A long-term, randomized, double-blind study. N Engl J Med. 1980 May 1;302(18):981-7. doi: 10.1056/NEJM198005013021801.
PubMed 6102739Pearson DC, May GR, Fick GH, Sutherland LR. Azathioprine and 6-mercaptopurine in Crohn disease. A meta-analysis. Ann Intern Med. 1995 Jul 15;123(2):132-42. doi: 10.7326/0003-4819-123-2-199507150-00009.
PubMed 7778826Grimaud JC, Munoz-Bongrand N, Siproudhis L, Abramowitz L, Senejoux A, Vitton V, Gambiez L, Flourie B, Hebuterne X, Louis E, Coffin B, De Parades V, Savoye G, Soule JC, Bouhnik Y, Colombel JF, Contou JF, Francois Y, Mary JY, Lemann M; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif. Fibrin glue is effective healing perianal fistulas in patients with Crohn's disease. Gastroenterology. 2010 Jun;138(7):2275-81, 2281.e1. doi: 10.1053/j.gastro.2010.02.013. Epub 2010 Feb 20.
PubMed 20178792
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00723047
- Acronym / sponsor ID
- Fibrin glue / GETAID 2003-1
- Conditions
- Crohn's Disease
- Keywords
- Patients, CD complicated, least, One perianal fistula, Draining, 2 months duration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesUniversity, hospital or other
- Collaborators
- Nycomed, Société Nationale Française de Gastroentérologie
- Study start
- Nov 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 28 Jul 2008 (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 multicenter, randomized, controlled trial was conducted by the Groupe d'Etude Thérapeutique des Affections Inflammatoires du tube Digestif (GETAID) to evaluate the efficacy and safety of the injection of fibrin glue in perianal fistulas tracts of patients with CD. The institutional Independent Ethics Committee of Marseille, France and of Liège, Belgium approved the protocol for each participating centers. Recruitment took place at 12 sites (11 in France and 1 in Belgium)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Fibrin glue injection in fistula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 18 years old
- CD confirmed by endoscopy and histology.
- CDAI should be 250 or less
- at least one perianal fistula (between anus or low rectum and perineum, vulva or vagina) draining for more than 2 months duration
Key exclusion criteria (6 listed)
- treatment with an anti-TNF agent or with ciclosporin or tacrolimus within the last 3 months
- presence of a perianal abscess (>1cm) assessed by magnetic resonance imaging (MRI) or endo-anal ultrasonography performed within the last month,
- presence of anal or rectal stenosis,
- surgery during the previous month (except seton removal),
- previous fibrin glue injection,
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 |
|---|---|---|
| Fibrin glue injection in fistula | Procedure or surgery | 1 |
Primary outcome
Clinical Remission
Time frame: 8 weeks after inclusion
Clinical remission was defined as * the absence of any draining by fistula openings occurring spontaneously or after gentle finger compression , * the absence of perianal pain * and the absence of perianal abscess.
2 secondary outcomes
Early Clinical Remission
Time frame: 4 weeks after Inclusion
Occurrence of perianal abcess
Time frame: During whole study
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 5 Sep 2011.
- Background: PubMed 7429313Hellers G, Bergstrand O, Ewerth S, Holmstrom B. Occurrence and outcome after primary treatment of anal fistulae in Crohn's disease. Gut. 1980 Jun;21(6):525-7. doi: 10.1136/gut.21.6.525.
- Background: PubMed 11910338Schwartz DA, Loftus EV Jr, Tremaine WJ, Panaccione R, Harmsen WS, Zinsmeister AR, Sandborn WJ. The natural history of fistulizing Crohn's disease in Olmsted County, Minnesota. Gastroenterology. 2002 Apr;122(4):875-80. doi: 10.1053/gast.2002.32362.
- Background: PubMed 11712881Schwartz DA, Pemberton JH, Sandborn WJ. Diagnosis and treatment of perianal fistulas in Crohn disease. Ann Intern Med. 2001 Nov 20;135(10):906-18. doi: 10.7326/0003-4819-135-10-200111200-00011.
- Background: PubMed 7399243Bernstein LH, Frank MS, Brandt LJ, Boley SJ. Healing of perineal Crohn's disease with metronidazole. Gastroenterology. 1980 Aug;79(2):357-65.
- Background: PubMed 6102739Present DH, Korelitz BI, Wisch N, Glass JL, Sachar DB, Pasternack BS. Treatment of Crohn's disease with 6-mercaptopurine. A long-term, randomized, double-blind study. N Engl J Med. 1980 May 1;302(18):981-7. doi: 10.1056/NEJM198005013021801.
- Background: PubMed 7778826Pearson DC, May GR, Fick GH, Sutherland LR. Azathioprine and 6-mercaptopurine in Crohn disease. A meta-analysis. Ann Intern Med. 1995 Jul 15;123(2):132-42. doi: 10.7326/0003-4819-123-2-199507150-00009.
- Derived from this study: PubMed 20178792Grimaud JC, Munoz-Bongrand N, Siproudhis L, Abramowitz L, Senejoux A, Vitton V, Gambiez L, Flourie B, Hebuterne X, Louis E, Coffin B, De Parades V, Savoye G, Soule JC, Bouhnik Y, Colombel JF, Contou JF, Francois Y, Mary JY, Lemann M; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif. Fibrin glue is effective healing perianal fistulas in patients with Crohn's disease. Gastroenterology. 2010 Jun;138(7):2275-81, 2281.e1. doi: 10.1053/j.gastro.2010.02.013. Epub 2010 Feb 20.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fibrin glue injection in fistula in people with Crohn's Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 14 sites in 2 countries.
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 5 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France, Belgium. 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?
Clinical Remission (time frame: 8 weeks after inclusion). 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 NCT00723047, which also lists 7 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 5 Sep 2011.