Effect of additional single or repeated dosage of Kappaproct® to corticosteroid treated patients with brain oedema caused by brain tumour
| ISRCTN | ISRCTN84460768 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84460768 |
| Protocol serial number | InDex-CSBTE-01-09 |
| Sponsor | InDex Pharmaceutials AB (Sweden) |
| Funder | InDex Pharmaceutials AB (Sweden) |
- Submission date
- 22/10/2009
- Registration date
- 02/12/2009
- Last edited
- 02/12/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Thomas Asklund
Scientific
Scientific
Department of Oncology
Norrlands University Hospital
Umeå
SE-90185
Sweden
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open one armed non-randomised multicentre trial |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effect of additional single or repeated dosage of Kappaproct® to corticosteroid treated patients with brain oedema caused by brain tumour: a multicentre open one-arm non-randomised trial |
| Study acronym | Kappaproct® study |
| Study objectives | To evaluate the effect of an additional single dose of Kappaproct® to corticosteroid treated patients with brain oedema caused by brain tumour, measured as reduction of the volume of the oedema by magnetic resonance imaging (MRI). |
| Ethics approval(s) | Local Ethical Committee in Umeå approved on the 1st April 2009 (ref: 09-054M) |
| Health condition(s) or problem(s) studied | Brain oedema due to brain tumour |
| Intervention | A single dose of 30 mg Kappaproct® (DIMS0150) given as a rectal enema. The patients are followed for 20 days after treatment. |
| Intervention type | Drug |
| Phase | Phase I/II |
| Drug / device / biological / vaccine name(s) | Kappaproct® |
| Primary outcome measure(s) |
Efficacy assessment: measurement of the volume of the brain oedema with MRI, measured at 10 days after treatment. |
| Key secondary outcome measure(s) |
Assessed at 10 and 20 days after treatment: |
| Completion date | 31/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Adult men and women (greater than 18 year) with malignant brain oedema confirmed by MRI/computed tomography (CT), caused by malignant glioma, menigioma or metastatic disease (histological and/or cytological verified) 2. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance 0 - 3 3. Betapred® (betamethasone) dose 8 mg x 2 for more than 24 hours 4. Clinical need for increase of corticosteroid dosage 5. Possibility to perform repeated MRI examinations |
| Key exclusion criteria | 1. History and precence of a clinical significant cardiovascular, hepatic, haematological, endocrine, neurological and psychiatric disease or immune compromised state as judged by the investigator 2. Chemotherapy that has been administrated within 4 weeks prior to inclusion 3. Positive urine pregnancy test in women at enrolment 4. Intake of drug under investigation |
| Date of first enrolment | 01/11/2009 |
| Date of final enrolment | 31/10/2011 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Department of Oncology
Umeå
SE-90185
Sweden
SE-90185
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
