E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with active incomplete microscopic colitis |
Patienter med aktiv inkomplett mikroskopisk kolit |
|
E.1.1.1 | Medical condition in easily understood language |
Patients with active incomplete microscopic colitis |
Patienter med aktiv inkomplett mikroskopisk kolit |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10056979 |
E.1.2 | Term | Colitis microscopic |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the trial is to demonstrate efficacy of budesonide for induction of remission in patients with active incomplete microscopic colitis |
Det primära syftet med studien är att påvisa effekt av budesonid på induktion av remission hos patienter med aktiv inkomplett mikroskopisk kolit |
|
E.2.2 | Secondary objectives of the trial |
The second objective of the trial is to study the maintenance of remission after end of treatment and the safety, tolerability of budesonide granules in patients with incomplete microscopic colitis |
Sekundärt syfte med studien är att studera varaktighet av remission efter behandling samt säkerhet och tolerabilitet för budesonid granulat hos patienter med inkomplett mikroskopisk kolit |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Signed informed consent
2. Man or woman between 18 and 80 years of age
3. Histologically established diagnosis of incomplete microscopic colitis
4. History of chronic non-bloody, watery diarrhoea for at least 4 weeks
5. Clinically active disease
|
1. Signerat informerat samtycke
2. Män eller kvinnor mellan 18 och 80 år
3. Histologiskt verifierad diagnos; inkomplett microskopisk kolit
4. Sjukhistoria med kronisk icke-blodig, vattnig diarré i minst 4 veckor
5. Kliniskt aktiv sjukdom
|
|
E.4 | Principal exclusion criteria |
1. Other significant abnormalities in colonoscopy that may have been the cause of diarrhoea except for colonic diverticulosis and non-dysplastic polyps < 2 cm,
2. Infectious cause of diarrhoea (local routine stool samples, Clostridium difficile included) or history of infectious diarrhoea within the last 3 months prior inclusion or local intestinal infection,
3. Clinical suspicion of drug-induced diarrhoea,
4. Prior and present MC (i.e., all histological criteria for collagenous colitis or lymphocytic colitis fulfilled),
5. History of bowel resection (except appendectomy, haemorrhoidectomy and endoscopic removal of polyps),
6. Radiation therapy of the abdominal or pelvic region,
7. Positive antibody titres for celiac disease (tGT IgA + serum IgA), or any known history of celiac disease,
8. Untreated active thyroid dysfunction,
9. Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder reducing life expectancy,
10. Abnormal hepatic function (ALT or ALP > 2.5 x upper limit of normal [ULN]), liver cirrhosis, or portal hypertension,
11. Tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured,
12. History of colorectal cancer,
13. History of cancer (other than colorectal) in the last 5 years,
14. Therapy with immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate) within 3 months prior to baseline,
15. Treatment with budesonide or other steroids within 4 weeks prior to baseline,
16. Treatment with antibiotics within 4 weeks prior to baseline,
17. Treatment with anti-diarrhoeal drugs (e.g., loperamide, ispaghula, codeine, and opium), cholestyramine, bulking agents, spasmolytics, bismuth, and probiotics within 2 weeks prior to baseline,
18. Known intolerance/hypersensitivity/resistance to the trial drug or drugs of similar chemical structure or pharmacological profile,
19. Current or intended pregnancy or breast-feeding,
20. Doubt about the patient’s cooperation, e.g. because of addiction to alcohol or drugs,
21. Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial,
22. Live vaccination within the last 4 weeks before the baseline visit,
23. Diagnosis of chickenpox, herpes zoster or measles within the last 3 months before the baseline visit. |
1. Andra signifikanta abnormaliteter vid koloskopi som kan ha varit orsak till diarré
2. Infektiös orsak till diarré
3. Klinisk misstanke på läkemedelsinducerad diarré
4. Tidigare och pågående MC
5. Historik av tarmresektion (utom blindtarmsoperation , haemorrhoidectomy och endoskopisk avlägsnande av polyper),
6. Strålbehandling av buk -bäckenregionen
7. Positiva antikroppstitrar för celiaki (tGT IgA + serum IgA), eller någon känd historia av celiaki,
8. Sjukhistoria med kolorektal cancer
9. Behandling med imunomodulatorer de senaste 3 månaderna
10. Behandling med budesonid, andra steroider eller antibiotika de senaste 4 veckorna
11. Behandling med antidiarroikum, bulkmedel och spasmolytika de senaste 2 veckorna
12. Historik av kolorektal cancer,
13. Historik av cancer (annat än kolorektal) under de senaste 5 åren,
14. Behandling med immunmodulerande (t ex azatioprin, 6-merkaptopurin eller metotrexat) inom 3 månader före baslinje,
15. Behandling med budesonid eller andra steroider inom 4 veckor före baslinjen,
16. Behandling med antibiotika inom 4 veckor före baslinjen,
17. Behandling med läkemedel mot diarré (t ex loperamid, ispaghula, kodein och opium), kolestyramin, bulkmedel , spasmolytika, vismut, och probiotika inom 2 veckor före baslinjen,
18. Känd intolerans / överkänslighet / resistens mot försöksläkemedlet eller läkemedel av liknande kemisk struktur eller farmakologisk profil,
19. Aktuell eller avsedd graviditet eller amning,
20. Tvivel om patientens samarbete, t.ex. på grund av missbruk av alkohol eller droger,
21. Deltagande i en annan klinisk prövning inom de senaste 30 dagarna, samtidigt deltagande i en annan klinisk prövning, eller tidigare deltagande i denna studie,
22. Levande vaccin under de senaste 4 veckorna före baslinjebesöket,
23. Diagnos av vattkoppor, herpes zoster eller mässling under de senaste 3 månaderna före baslinjebesöket |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Rate of clinical remission at final/withdrawal visit |
Grad av klinisk remission på sista besöket |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 8 weeks of treatment |
Efter 8 veckors behandling |
|
E.5.2 | Secondary end point(s) |
Double-blind phase:
• Rate of clinical remission
• Time to remission
• Change in total number of stools
• Change in number of days with abdominal pain
• Change in number of days with bloating
• Changes in histological signs
• Rate of histological remission/improvement
• Physician’s Global Assessment (PGA)
• Short Health Scale (SHS)
Follow-up phase:
• Rate of responders maintaining clinical remission
• Rate of patients with relapse
• Time to relapse |
Dubbelblind fas:
• Grad av klinisk remission
• Tid till remission
• Förändring av totala antalet avföringar
• Förändring av antal dagar med buksmärta
• Förändring av antal dagar med uppsvälldhet
• Förändring av histologiska kännetecken
• Grad av histologisk remission / förbättring
• Physician’s Global Assessment (PGA)
• Short Health Scale (SHS)
Uppföljningsfas:
• Andel patienter som svarade på behandling och vidhöll klinisk remission
• Andel patienter med återfall
• Tid tills återfall |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Each visit, if not otherwise defined |
Varje besök, om inte annat är definierat |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Sista besök sista patient |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |