Digestive FistulaePhase 3NCT00729313
Efficacy and Safety of Lanreotide Versus Placebo for Treatment of Patients With Digestive Fistulae
A Phase 3 study testing Lanreotide microparticles in people with Digestive Fistulae, run by Ipsen at 19 sites in 2 countries.
Trial summary
The purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the treatment of patients with digestive fistulae. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Digestive Fistulae
- What is being tested?
- Lanreotide microparticles
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Apr 2000to Apr 2005
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with pancreatic, duodenal, or small intestine fistula
- Patient with simple, externalised fistula
- Patient with fistula for which a medical conservative treatment is considered
- Patient with:
- for pancreatic fistulae: a mean drainage volume more than or equal to 100 ml/24h over 48 hours or more than or equal to 50 ml / 24h over 3 days and a concentration of amylase in the drainage fluid 3 times higher than in the serum over at least 2 or 3 consecutive days respectively,
- for duodenal and small intestine fistulae: a mean drainage volume more than or equal to 100ml/24h over 2 days
Who cannot join
- Patient expected to require a surgical treatment of the fistula during the study
- Patient having uncontrolled intra-abdominal sepsis; Crohn's disease; radiotherapy lesions of the small bowel; a mesenteric vascular insufficiency; a fistula localised in cancer-infiltrated areas; a distal obstruction; an exposed fistula of the small intestine; or intra-abdominal foreign bodies.
- Patient receiving long-term corticotherapy
- Patient having received any somatostatin analogue as curative treatment of the fistula or any PRF somatostatin analogue within the previous month.
- Patient having previously undergone a transplant
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
France17 sites
Hôpital Nord
Amiens, 80054
CHU J. Minjoz
Besançon, 25031
Hôpital Avicenne
Bobigny, 93009
Hôpital de la Cavale Blanche
Brest, 29609
Hôpital Louis Mourier
Colombes, 92700
Hôpital Henri Mondor
Créteil, 94000
Hôpital A. Michallon
Grenoble, 38043
CHU de Bicêtre
Le Kremlin-Bicêtre, 94275
Hôpital Edouard Herriot
Lyon, 69003
Hotel Dieu
Lyon, 69288
Hôpital Nord
Marseille, 13915
Hôpital Lariboisière
Paris, 75010
Groupe Hospitalier Pitié-Salpêtrière
Paris, 75013
Hôpital Pontchaillou
Rennes, 35033
Hôpital de Hautepierre
Strasbourg, 67098
Hôpital Trousseau
Tours, 37044
Hôpital de Brabois
Vandœuvre-lès-Nancy, 54500
Russia2 sites
Institute of Surgery n.a. A.V. Vishnevsky
Moscow, 113811
National Research Centre of Surgery
Moscow, 119992
About this study
Official title: A Phase III Multicentre Randomised Double-blind Comparative Study of Efficacy and Safety of Lanreotide 30 mg Versus Placebo for Treatment of Patients With Digestive Fistulae
The purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the treatment of patients with digestive fistulae.
Read the detailed description
The purpose of this study is to determine whether lanreotide 30mg compared to placebo is effective on the evolution of drainage volume of digestive fistulae in the 72 hours following the beginning of treatment and on the spontaneous closure time of digestive fistulae.
- Conditions
- Digestive Fistulae
- Being tested
- Lanreotide microparticles, Placebo
- Keywords
- Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanreotide microparticlesDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Drug: Lanreotide 30 mg microparticle formulation
One intra-muscular injection.
A (maximum) 60 day "treatment" period (6 intra-muscular injections of lanreotide 30 mg microparticle formulation every 10 days): according to the patient's treatment response at 72h
For non-responders patients lanreotide will be stopped. Receives: Drug: Lanreotide microparticles |
| 2 | Placebo comparator | One intra-muscular injection.
A (maximum) 60 day "treatment" period (6 intra-muscular injections of placebo every 10 days): according to the patient's treatment response at 72h.
Non-responder patients having received placebo on the first injection should receive an open-labelled lanreotide treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a reduction of fistula drainage volume > 50% of baseline at 72 hours.
Measured: Fistula drainage volume on 3rd day.
Secondary outcomes (5)
Closure time of digestive fistulae will be defined by the interval between D0 (day of the first injection) and the date of spontaneous closure of the fistula.
Measured: Day 60
Pancreatic or duodenal and small intestine fistula closing rate within D60
Measured: Day 60
Number of injections received by each patient
Measured: End of study
Percentage of fistula recurrence during the follow-up period
Measured: Duration of follow-up period for each patient is of 1 month
Percentage of mortality in each group
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2008 (estimated)
- Study startApr 2000
- Primary completionApr 2005
- Study completionApr 2005
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 Digestive FistulaeStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729313
- Sponsor's protocol ID
- E-54-52030-053
- Status last verified
- Mar 2019
- First submitted
- 4 Aug 2008
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Gayral F, Campion JP, Regimbeau JM, Blumberg J, Maisonobe P, Topart P, Wind P; Lanreotide Digestive Fistula. Randomized, placebo-controlled, double-blind study of the efficacy of lanreotide 30 mg PR in the treatment of pancreatic and enterocutaneous fistulae. Ann Surg. 2009 Dec;250(6):872-7. doi: 10.1097/sla.0b013e3181b2489f.
PubMed 19953707
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Multicentre Randomised Double-blind Comparative Study of Efficacy and Safety of Lanreotide 30 mg Versus Placebo for Treatment of Patients With Digestive Fistulae
- ClinicalTrials.gov ID
- NCT00729313
- Acronym / sponsor ID
- E-54-52030-053
- Conditions
- Digestive Fistulae
- Keywords
- Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Apr 2000
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 7 Aug 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.
The purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the treatment of patients with digestive fistulae.
Detailed description
The purpose of this study is to determine whether lanreotide 30mg compared to placebo is effective on the evolution of drainage volume of digestive fistulae in the 72 hours following the beginning of treatment and on the spontaneous closure time of digestive fistulae.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Lanreotide microparticlesDrug: Lanreotide 30 mg microparticle formulation One intra-muscular injection. A (maximum) 60 day "treatment" period (6 intra-muscular injections of lanreotide 30 mg microparticle formulation every 10 days): according to the patient's treatment response at 72h For non-responders patients lanreotide will be stopped. |
| 2 | Placebo comparator | Drug: PlaceboOne intra-muscular injection. A (maximum) 60 day "treatment" period (6 intra-muscular injections of placebo every 10 days): according to the patient's treatment response at 72h. Non-responder patients having received placebo on the first injection should receive an open-labelled lanreotide treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with pancreatic, duodenal, or small intestine fistula
- Patient with simple, externalised fistula
- Patient with fistula for which a medical conservative treatment is considered
- Patient with:
- for pancreatic fistulae: a mean drainage volume more than or equal to 100 ml/24h over 48 hours or more than or equal to 50 ml / 24h over 3 days and a concentration of amylase in the drainage fluid 3 times higher than in the serum over at least 2 or 3 consecutive days respectively,
Key exclusion criteria (5 listed)
- Patient expected to require a surgical treatment of the fistula during the study
- Patient having uncontrolled intra-abdominal sepsis; Crohn's disease; radiotherapy lesions of the small bowel; a mesenteric vascular insufficiency; a fistula localised in cancer-infiltrated areas; a distal obstruction; an exposed fistula of the small intestine; or intra-abdominal foreign bodies.
- Patient receiving long-term corticotherapy
- Patient having received any somatostatin analogue as curative treatment of the fistula or any PRF somatostatin analogue within the previous month.
- Patient having previously undergone a transplant
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 |
|---|---|---|
| Lanreotide microparticles | Drug | 1 |
| Placebo | Drug | 2 |
Primary outcome
Number of patients with a reduction of fistula drainage volume > 50% of baseline at 72 hours.
Time frame: Fistula drainage volume on 3rd day.
5 secondary outcomes
Closure time of digestive fistulae will be defined by the interval between D0 (day of the first injection) and the date of spontaneous closure of the fistula.
Time frame: Day 60
Pancreatic or duodenal and small intestine fistula closing rate within D60
Time frame: Day 60
Number of injections received by each patient
Time frame: End of study
Percentage of fistula recurrence during the follow-up period
Time frame: Duration of follow-up period for each patient is of 1 month
Percentage of mortality in each group
Time frame: End of 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 4 Mar 2019.
- Results publication: PubMed 19953707Gayral F, Campion JP, Regimbeau JM, Blumberg J, Maisonobe P, Topart P, Wind P; Lanreotide Digestive Fistula. Randomized, placebo-controlled, double-blind study of the efficacy of lanreotide 30 mg PR in the treatment of pancreatic and enterocutaneous fistulae. Ann Surg. 2009 Dec;250(6):872-7. doi: 10.1097/sla.0b013e3181b2489f.
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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.
Ipsen Medical Director study director
Ipsen
19 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 Lanreotide microparticles in people with Digestive Fistulae, run by Ipsen at 19 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 6 inclusion and 5 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 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, Russia. 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 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?
Number of patients with a reduction of fistula drainage volume > 50% of baseline at 72 hours. (time frame: Fistula drainage volume on 3rd day.). 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 NCT00729313, 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 4 Mar 2019.