AngiodysplasiaPhase 2ANGIOPASNCT02622906
Pasireotide for the Treatment of Gastrointestinal Angiodysplasia in Endoscopic Treatment Failure
A Phase 2 study testing Pasireotide in people with Angiodysplasia, run by Robert Benamouzig at 1 site in France.
Trial summary
The angiodysplasias may be responsible for recurrent gastrointestinal bleeding and in some cases bleeding remaining inaccessible to endoscopic treatment. Several observational studies suggest that treatment with somatostatin analogue would reduce transfusion requirements in patients with recurrent bleeding due to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angiodysplasia
- What is being tested?
- Pasireotide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Oct 2015
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Angiodysplasia of the stomach, small intestine or colon confirmed by endoscopy.
- 6 or more of packed red cells unit transfusion during the 6 months prior inclusion.
- Failed endoscopic therapy or cons-indication for endoscopic treatment.
- Patient affiliated to a social security insurance.
- Age > 18 years.
- Consent signed by the patient.
Who cannot join
- Treatment with somatostatin analogue in the 6 months prior to inclusion
- Symptomatic cholelithiasis
- Rendu-Osler disease
- Uncontrolled diabetes (HbA1c > 8%)
- Breaking of the esophageal varicose veins bleeding older than six months.
- Patients treated with anti vitamin K at baseline and during the study.
Show all 15Show fewer
- Patients with (AST, ALT> 2 ULN) and / or total bilirubin > 1.5 ULN.
- TP < 50%, platelets <75 000/mm3, aPTT> 1.5 times the control
- Uncontrolled heart disease: myocardial infarction within 6 months, status epilepticus angina, congestive heart failure grade III and NYHA, ventricular tachycardia, ventricular fibrillation, heart block, severe
- Family medical history of the idiopathic sudden death
- Syncope like medical history
- QTcF> 450 ms
- Metastatic malignancy
- Pregnant or nursing women, women of childbearing age who have not achieved pregnancy test, women and men of reproductive age without effective contraception
- Impossible follow for psychological and/or geographical reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase II Trial Evaluating the Efficiency of Pasireotide for the Treatment of Gastrointestinal Angiodysplasia in Endoscopic Treatment Failure
The angiodysplasias may be responsible for recurrent gastrointestinal bleeding and in some cases bleeding remaining inaccessible to endoscopic treatment. Several observational studies suggest that treatment with somatostatin analogue would reduce transfusion requirements in patients with recurrent bleeding due to angiodysplasia.
No randomized studies are available. The main objective of this study multicenter, prospective, randomized, was to assess the transfusion requirements in patients with recurrent bleeding due to angiodysplasia treated by a new analogue of somatostatin, Pasireotide, versus placebo.
Patients with recurrent gastrointestinal bleeding related to angiodysplasias, endoscopic treatment failure, with a need transfusion at least 6 red blood cells during the 6 months prior to inclusion could be randomized to receive monthly intramuscular injection of Pasireotide 60 mg or placebo for a period of 6 months. Patients were then followed for an additional 6 months after stopping treatment. A test monthly clinical and laboratory was performed during the six months of treatment then quarterly during the six months of surveillance.
Read the detailed description
The angiodysplasias are abnormal communications between dilated capillaries and veins. Their presence in the digestive tract is probably due to venous obstruction associated with smooth muscle contractions. These vascular malformations are not a particularly significant cause of bleeding in elderly patients. The angiodysplasias are responsible for about 1% of upper gastrointestinal bleeding and up to 6% of the lower bleeding. However in case of gastrointestinal bleeding obscures the presence of angiodysplasia was found in 23% of cases through an exploration of the small intestine endoscopic video capsule enteroscopy or double balloon. Some conditions promote the development of angiodysplasias such as kidney failure with a prevalence of 13% in case of bleeding or cirrhosis. The responsibility of aortic stenosis is debated and could be a chance association. On the other hand, are more symptomatic bleeding in case of bleeding disorders, in particular von Willebrand disease.
The first line treatment is based on the destruction of endoscopic lesions by laser, or argon plasma coagulation electrocoagulation. However, these lesions may be inaccessible to endoscopic treatment, when they are too numerous or if patients with severe comorbidities, indicating against invasive endoscopic treatments. Iterative transfusions remain the only possible treatment for a significant proportion of patient which induces frequent hospitalizations, complications related to transfusions and a significant cost.
Hormonal treatments have been tried without success to prevent rebleeding. Anti-angiogenic as thalidomide have been tested in phase II trials in low number of the patients.
Somatostatin is a cyclic peptide secreted by D cells in the gastric and intestinal mucosa, by the cells of the islets of Langerrhans. There are five known somatostatin receptors which when activated by the ligand caused an inhibition of gastric acid secretion, pancreatic and biliary secretions. The somatostatin analogues have different vascular effects documented as downregulation of VEGF expression or decreasing the splanchnic flow.
Thus, the somatostatin analogs can have an effect on the prevention of rebleeding secondary to angiodysplasia by several mechanisms: inhibition of angiogenesis, reduction of splanchnic blood flow, increased vascular resistance and increased platelet aggregation.
Several cohort studies suggest that treatment with somatostatin analogues, octreotide can reduce the need for transfusion in patients with recurrent bleeding due to angiodysplasia. A meta-analysis of these studies, which included 62 patients in total found a relative risk of rebleeding of 0.76 (95% CI: 0.64 to 0.85) and a decrease of 2.2 transfusions (95% : -3.9 to -0.5) between the period before the treatment and the period of treatment with octreotide.
To date, there are no randomized phase III study to suggest the efficacy of somatostatin analogues in the prevention of rebleeding due to angiodysplasia.
Pasireotide is a new analogue of somatostatin which has a higher affinity of Octreotide to like receptors 1, 3 and 5. A preliminary study showed that pasireotide could be effective in the symptomatic treatment of endocrine tumors beyond the octreotide therapy. This superior efficacy of pasireotide compared to Octreotide justifies the evaluation pasireotide in the prevention of rebleeding due to angiodysplasia. Side effects described with the LP pasireotide are the possibility of post prandial hyperglycemia transient dose-dependent. Episodes of intestinal disorders have been reported (diarrhea, nausea, vomiting), but usually require no medicinal treatment and disappearing spontaneously during treatment.
All these data suggests for a randomized study against placebo to establish the efficacy of treatment with pasireotide LP in the prevention of rebleeding due to angiodysplasia. A randomized phase II feasibility study will be conducted to verify the the investigators hypotheis and followed if necessary by a phase III study.
Somatostatin analogs have vascular action that has been shown in other pathologies (gastrointestinal bleeding in patients with portal hypertension). Cohort studies suggest efficacy in reduction of transfusion requirements in patients with gastrointestinal angiodysplasia. In case of failure of endoscopic treatment there is no currently licensed treatment for the prevention of rebleeding in these patients.
The investigators objective is to evaluate the reduction in the number of red blood cells transfused to M6 in patients treated with pasireotide LP or placebo.
- Conditions
- Angiodysplasia
- Being tested
- Pasireotide, Placebo
- Keywords
- Gastrointestinal angiodysplasia, Pasireotide, Gastrointestinal bleeding
- Medical subject headings
- Angiodysplasia, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PasireotideDrug
60 mg per month of the Pasireotide during 6 months
PlaceboDrug
Vehicule injection per month during 6 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 1 injection per month during 6 months of the placebo product Receives: Drug: Placebo |
| Pasireotide | Active comparator | 1 injection per month during 6 months of the Pasireotide LP (60mg/injection) Receives: Drug: Pasireotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of red blood cells transfused
number of red blood cells transfused at 6 months in patients treated with pasireotide or placebo.
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study startMar 2012
- Primary completionMar 2012
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for AngiodysplasiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Benamouzig
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert Benamouzig, Hospital Avicenne
- Investigators
- Robert BENAMOUZIG, Principal investigator, Société Française d'Endoscopie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622906
- Sponsor's protocol ID
- 2011-002579-40
- Acronym
- ANGIOPAS
- Status last verified
- Dec 2015
- First submitted
- 3 Dec 2015
- Last updated
- 7 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Boley SJ, Sammartano R, Adams A, DiBiase A, Kleinhaus S, Sprayregen S. On the nature and etiology of vascular ectasias of the colon. Degenerative lesions of aging. Gastroenterology. 1977 Apr;72(4 Pt 1):650-60.
PubMed 300063Foutch PG, Rex DK, Lieberman DA. Prevalence and natural history of colonic angiodysplasia among healthy asymptomatic people. Am J Gastroenterol. 1995 Apr;90(4):564-7.
PubMed 7717311Vreeburg EM, Snel P, de Bruijne JW, Bartelsman JF, Rauws EA, Tytgat GN. Acute upper gastrointestinal bleeding in the Amsterdam area: incidence, diagnosis, and clinical outcome. Am J Gastroenterol. 1997 Feb;92(2):236-43.
PubMed 9040198Ohmiya N, Yano T, Yamamoto H, Arakawa D, Nakamura M, Honda W, Itoh A, Hirooka Y, Niwa Y, Maeda O, Ando T, Yao T, Matsui T, Iida M, Tanaka S, Chiba T, Sakamoto C, Sugano K, Goto H. Diagnosis and treatment of obscure GI bleeding at double balloon endoscopy. Gastrointest Endosc. 2007 Sep;66(3 Suppl):S72-7. doi: 10.1016/j.gie.2007.05.041.
PubMed 17709039Chalasani N, Cotsonis G, Wilcox CM. Upper gastrointestinal bleeding in patients with chronic renal failure: role of vascular ectasia. Am J Gastroenterol. 1996 Nov;91(11):2329-32.
PubMed 8931412Bhutani MS, Gupta SC, Markert RJ, Barde CJ, Donese R, Gopalswamy N. A prospective controlled evaluation of endoscopic detection of angiodysplasia and its association with aortic valve disease. Gastrointest Endosc. 1995 Nov;42(5):398-402. doi: 10.1016/s0016-5107(95)70038-2.
PubMed 8566626Veyradier A, Balian A, Wolf M, Giraud V, Montembault S, Obert B, Dagher I, Chaput JC, Meyer D, Naveau S. Abnormal von Willebrand factor in bleeding angiodysplasias of the digestive tract. Gastroenterology. 2001 Feb;120(2):346-53. doi: 10.1053/gast.2001.21204.
PubMed 11159874Pavey DA, Craig PI. Endoscopic therapy for upper-GI vascular ectasias. Gastrointest Endosc. 2004 Feb;59(2):233-8. doi: 10.1016/s0016-5107(03)02539-2.
PubMed 14745397Junquera F, Feu F, Papo M, Videla S, Armengol JR, Bordas JM, Saperas E, Pique JM, Malagelada JR. A multicenter, randomized, clinical trial of hormonal therapy in the prevention of rebleeding from gastrointestinal angiodysplasia. Gastroenterology. 2001 Nov;121(5):1073-9. doi: 10.1053/gast.2001.28650.
PubMed 11677198Bauditz J, Lochs H, Voderholzer W. Macroscopic appearance of intestinal angiodysplasias under antiangiogenic treatment with thalidomide. Endoscopy. 2006 Oct;38(10):1036-9. doi: 10.1055/s-2006-944829.
PubMed 17058171Dabak V, Kuriakose P, Kamboj G, Shurafa M. A pilot study of thalidomide in recurrent GI bleeding due to angiodysplasias. Dig Dis Sci. 2008 Jun;53(6):1632-5. doi: 10.1007/s10620-007-0067-z.
PubMed 17990111Kurosaki M, Saegert W, Abe T, Ludecke DK. Expression of vascular endothelial growth factor in growth hormone-secreting pituitary adenomas: special reference to the octreotide treatment. Neurol Res. 2008 Jun;30(5):518-22. doi: 10.1179/174313208X289499.
PubMed 18953743Ludwig D, Terai S, Bruning A, Stange EF. Long-term haemodynamic effects of octreotide on postprandial splanchnic hyperemia in humans: a placebo-controlled echo-doppler study. Aliment Pharmacol Ther. 1999 Aug;13(8):1119-29. doi: 10.1046/j.1365-2036.1999.00583.x.
PubMed 10468691Szilagyi A, Ghali MP. Pharmacological therapy of vascular malformations of the gastrointestinal tract. Can J Gastroenterol. 2006 Mar;20(3):171-8. doi: 10.1155/2006/859435.
PubMed 16550261Nardone G, Rocco A, Balzano T, Budillon G. The efficacy of octreotide therapy in chronic bleeding due to vascular abnormalities of the gastrointestinal tract. Aliment Pharmacol Ther. 1999 Nov;13(11):1429-36. doi: 10.1046/j.1365-2036.1999.00647.x.
PubMed 10571598
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial Evaluating the Efficiency of Pasireotide for the Treatment of Gastrointestinal Angiodysplasia in Endoscopic Treatment Failure
- ClinicalTrials.gov ID
- NCT02622906
- Acronym / sponsor ID
- ANGIOPAS / 2011-002579-40
- Conditions
- Angiodysplasia
- Keywords
- Gastrointestinal angiodysplasia, Pasireotide, Gastrointestinal bleeding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Robert BenamouzigUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 7 Dec 2015 (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 angiodysplasias may be responsible for recurrent gastrointestinal bleeding and in some cases bleeding remaining inaccessible to endoscopic treatment. Several observational studies suggest that treatment with somatostatin analogue would reduce transfusion requirements in patients with recurrent bleeding due to angiodysplasia.
No randomized studies are available. The main objective of this study multicenter, prospective, randomized, was to assess the transfusion requirements in patients with recurrent bleeding due to angiodysplasia treated by a new analogue of somatostatin, Pasireotide, versus placebo.
Patients with recurrent gastrointestinal bleeding related to angiodysplasias, endoscopic treatment failure, with a need transfusion at least 6 red blood cells during the 6 months prior to inclusion could be randomized to receive monthly intramuscular injection of Pasireotide 60 mg or placebo for a period of 6 months. Patients were then followed for an additional 6 months after stopping treatment. A test monthly clinical and laboratory was performed during the six months of treatment then quarterly during the six months of surveillance.
Detailed description
The angiodysplasias are abnormal communications between dilated capillaries and veins. Their presence in the digestive tract is probably due to venous obstruction associated with smooth muscle contractions. These vascular malformations are not a particularly significant cause of bleeding in elderly patients. The angiodysplasias are responsible for about 1% of upper gastrointestinal bleeding and up to 6% of the lower bleeding. However in case of gastrointestinal bleeding obscures the presence of angiodysplasia was found in 23% of cases through an exploration of the small intestine endoscopic video capsule enteroscopy or double balloon. Some conditions promote the development of angiodysplasias such as kidney failure with a prevalence of 13% in case of bleeding or cirrhosis. The responsibility of aortic stenosis is debated and could be a chance association. On the other hand, are more symptomatic bleeding in case of bleeding disorders, in particular von Willebrand disease.
The first line treatment is based on the destruction of endoscopic lesions by laser, or argon plasma coagulation electrocoagulation. However, these lesions may be inaccessible to endoscopic treatment, when they are too numerous or if patients with severe comorbidities, indicating against invasive endoscopic treatments. Iterative transfusions remain the only possible treatment for a significant proportion of patient which induces frequent hospitalizations, complications related to transfusions and a significant cost.
Hormonal treatments have been tried without success to prevent rebleeding. Anti-angiogenic as thalidomide have been tested in phase II trials in low number of the patients.
Somatostatin is a cyclic peptide secreted by D cells in the gastric and intestinal mucosa, by the cells of the islets of Langerrhans. There are five known somatostatin receptors which when activated by the ligand caused an inhibition of gastric acid secretion, pancreatic and biliary secretions. The somatostatin analogues have different vascular effects documented as downregulation of VEGF expression or decreasing the splanchnic flow.
Thus, the somatostatin analogs can have an effect on the prevention of rebleeding secondary to angiodysplasia by several mechanisms: inhibition of angiogenesis, reduction of splanchnic blood flow, increased vascular resistance and increased platelet aggregation.
Several cohort studies suggest that treatment with somatostatin analogues, octreotide can reduce the need for transfusion in patients with recurrent bleeding due to angiodysplasia. A meta-analysis of these studies, which included 62 patients in total found a relative risk of rebleeding of 0.76 (95% CI: 0.64 to 0.85) and a decrease of 2.2 transfusions (95% : -3.9 to -0.5) between the period before the treatment and the period of treatment with octreotide.
To date, there are no randomized phase III study to suggest the efficacy of somatostatin analogues in the prevention of rebleeding due to angiodysplasia.
Pasireotide is a new analogue of somatostatin which has a higher affinity of Octreotide to like receptors 1, 3 and 5. A preliminary study showed that pasireotide could be effective in the symptomatic treatment of endocrine tumors beyond the octreotide therapy. This superior efficacy of pasireotide compared to Octreotide justifies the evaluation pasireotide in the prevention of rebleeding due to angiodysplasia. Side effects described with the LP pasireotide are the possibility of post prandial hyperglycemia transient dose-dependent. Episodes of intestinal disorders have been reported (diarrhea, nausea, vomiting), but usually require no medicinal treatment and disappearing spontaneously during treatment.
All these data suggests for a randomized study against placebo to establish the efficacy of treatment with pasireotide LP in the prevention of rebleeding due to angiodysplasia. A randomized phase II feasibility study will be conducted to verify the the investigators hypotheis and followed if necessary by a phase III study.
Somatostatin analogs have vascular action that has been shown in other pathologies (gastrointestinal bleeding in patients with portal hypertension). Cohort studies suggest efficacy in reduction of transfusion requirements in patients with gastrointestinal angiodysplasia. In case of failure of endoscopic treatment there is no currently licensed treatment for the prevention of rebleeding in these patients.
The investigators objective is to evaluate the reduction in the number of red blood cells transfused to M6 in patients treated with pasireotide LP or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo1 injection per month during 6 months of the placebo product |
| Pasireotide | Active comparator | Drug: Pasireotide1 injection per month during 6 months of the Pasireotide LP (60mg/injection) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Angiodysplasia of the stomach, small intestine or colon confirmed by endoscopy.
- 6 or more of packed red cells unit transfusion during the 6 months prior inclusion.
- Failed endoscopic therapy or cons-indication for endoscopic treatment.
- Patient affiliated to a social security insurance.
- Age > 18 years.
Key exclusion criteria (15 listed)
- Treatment with somatostatin analogue in the 6 months prior to inclusion
- Symptomatic cholelithiasis
- Rendu-Osler disease
- Uncontrolled diabetes (HbA1c > 8%)
- Breaking of the esophageal varicose veins bleeding older than six months.
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 |
|---|---|---|
| Pasireotide60 mg per month of the Pasireotide during 6 months | Drug | Pasireotide |
| PlaceboVehicule injection per month during 6 months | Drug | Placebo |
Primary outcome
number of red blood cells transfused
Time frame: at 6 months
number of red blood cells transfused at 6 months in patients treated with pasireotide or placebo.
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 7 Dec 2015.
- Background: PubMed 300063Boley SJ, Sammartano R, Adams A, DiBiase A, Kleinhaus S, Sprayregen S. On the nature and etiology of vascular ectasias of the colon. Degenerative lesions of aging. Gastroenterology. 1977 Apr;72(4 Pt 1):650-60.
- Background: PubMed 7717311Foutch PG, Rex DK, Lieberman DA. Prevalence and natural history of colonic angiodysplasia among healthy asymptomatic people. Am J Gastroenterol. 1995 Apr;90(4):564-7.
- Background: PubMed 9040198Vreeburg EM, Snel P, de Bruijne JW, Bartelsman JF, Rauws EA, Tytgat GN. Acute upper gastrointestinal bleeding in the Amsterdam area: incidence, diagnosis, and clinical outcome. Am J Gastroenterol. 1997 Feb;92(2):236-43.
- Background: PubMed 17709039Ohmiya N, Yano T, Yamamoto H, Arakawa D, Nakamura M, Honda W, Itoh A, Hirooka Y, Niwa Y, Maeda O, Ando T, Yao T, Matsui T, Iida M, Tanaka S, Chiba T, Sakamoto C, Sugano K, Goto H. Diagnosis and treatment of obscure GI bleeding at double balloon endoscopy. Gastrointest Endosc. 2007 Sep;66(3 Suppl):S72-7. doi: 10.1016/j.gie.2007.05.041.
- Background: PubMed 8931412Chalasani N, Cotsonis G, Wilcox CM. Upper gastrointestinal bleeding in patients with chronic renal failure: role of vascular ectasia. Am J Gastroenterol. 1996 Nov;91(11):2329-32.
- Background: PubMed 8566626Bhutani MS, Gupta SC, Markert RJ, Barde CJ, Donese R, Gopalswamy N. A prospective controlled evaluation of endoscopic detection of angiodysplasia and its association with aortic valve disease. Gastrointest Endosc. 1995 Nov;42(5):398-402. doi: 10.1016/s0016-5107(95)70038-2.
- Background: PubMed 11159874Veyradier A, Balian A, Wolf M, Giraud V, Montembault S, Obert B, Dagher I, Chaput JC, Meyer D, Naveau S. Abnormal von Willebrand factor in bleeding angiodysplasias of the digestive tract. Gastroenterology. 2001 Feb;120(2):346-53. doi: 10.1053/gast.2001.21204.
- Background: PubMed 14745397Pavey DA, Craig PI. Endoscopic therapy for upper-GI vascular ectasias. Gastrointest Endosc. 2004 Feb;59(2):233-8. doi: 10.1016/s0016-5107(03)02539-2.
- Background: PubMed 11677198Junquera F, Feu F, Papo M, Videla S, Armengol JR, Bordas JM, Saperas E, Pique JM, Malagelada JR. A multicenter, randomized, clinical trial of hormonal therapy in the prevention of rebleeding from gastrointestinal angiodysplasia. Gastroenterology. 2001 Nov;121(5):1073-9. doi: 10.1053/gast.2001.28650.
- Background: PubMed 17058171Bauditz J, Lochs H, Voderholzer W. Macroscopic appearance of intestinal angiodysplasias under antiangiogenic treatment with thalidomide. Endoscopy. 2006 Oct;38(10):1036-9. doi: 10.1055/s-2006-944829.
- Background: PubMed 17990111Dabak V, Kuriakose P, Kamboj G, Shurafa M. A pilot study of thalidomide in recurrent GI bleeding due to angiodysplasias. Dig Dis Sci. 2008 Jun;53(6):1632-5. doi: 10.1007/s10620-007-0067-z.
- Background: PubMed 18953743Kurosaki M, Saegert W, Abe T, Ludecke DK. Expression of vascular endothelial growth factor in growth hormone-secreting pituitary adenomas: special reference to the octreotide treatment. Neurol Res. 2008 Jun;30(5):518-22. doi: 10.1179/174313208X289499.
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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.
Robert BENAMOUZIG principal investigator
Société Française d'Endoscopie Digestive
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 Pasireotide in people with Angiodysplasia, run by Robert Benamouzig at 1 site in France.
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 15 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 7 Dec 2015. 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 France. 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?
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 red blood cells transfused (time frame: at 6 months). 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 NCT02622906, which also lists 18 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 7 Dec 2015.