Peritoneal NeoplasmsPhase 2NCT00332696
Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
A Phase 2 study testing Octreotide LAR, Octreotide (Immediate release) and methylprednisolone in people with Peritoneal Neoplasms and Intestinal Obstruction, run by Novartis Pharmaceuticals at 1 site in France.
Trial summary
To evaluate in combination with corticosteroid and local standard medical care the efficacy and safety of long-acting octreotide compared to placebo for the treatment of symptoms of inoperable bowel obstruction in patients with peritoneal carcinomatosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Neoplasms, Intestinal Obstruction, Carcinomatosis
- What is being tested?
- Octreotide LAR, Octreotide (Immediate release) and methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2005to Sep 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with symptoms and signs of inoperable bowel obstruction confirmed by a surgeon or clinic and radiographic assessment (CT scan or at least abdominal X-ray);
- Confirmed peritoneal carcinomatosis (with one of the following criteria : surgery, imaging and/or cytology);
- No corticotherapy at dose more than 1mg/kg equivalent-methylprednisolone, in the previous 2 weeks ;
- No chemotherapy in the previous week;
- No radio or chemotherapy planned at the inclusion and within the two weeks following inclusion
- Authorized concomitant treatments for local standard medical care : antiemetics, antispasmodics, anti-Histamine2 (H2) drugs blockers or proton pump inhibitor, analgesics; nasogastric tube
Who cannot join
- Abnormal coagulation (prothrombin time < 60%, platelets < 50x10^9/L).
- Non authorized concomitant treatments :
- Anticholinergics such as scopolamine
- Other somatostatin analogues
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
To evaluate in combination with corticosteroid and local standard medical care the efficacy and safety of long-acting octreotide compared to placebo for the treatment of symptoms of inoperable bowel obstruction in patients with peritoneal carcinomatosis
- Conditions
- Peritoneal Neoplasms, Intestinal Obstruction, Carcinomatosis
- Being tested
- Octreotide LAR, Octreotide (Immediate release), methylprednisolone, Placebo
- Keywords
- bowel obstruction,, peritoneal carcinomatosis, Octreotide, inoperable
- Medical subject headings
- Peritoneal Neoplasms, Intestinal Obstruction, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octreotide LARDrug
Also called Sandostatin® LAR
Octreotide long-acting release (LAR) 30 mg intramuscular injection.
Octreotide (Immediate release)Drug
Also called Sandostatin®
Immediate-release Octreotide supplied in 100 µg/mL ampules.
methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections).
PlaceboDrug
Physiologic saline solution
| Study group | Role | What they receive |
|---|---|---|
| Octreotide | Experimental | Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days. Receives: Drug: Octreotide LAR; Drug: Octreotide (Immediate release); Drug: methylprednisolone |
| Placebo | Placebo comparator | Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days. Receives: Drug: methylprednisolone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Success From Day 10 to Day 13
Treatment Success was defined as: less than 2 episodes of vomiting on average per day for the 4 days prior to Day 14 [from Day 10 to Day 13] and no use of an Nasogastric Tube (NGT) since at least Day 10 and no use of an anticholinergic agent until Day 14.
Treatment Failure is defined as: 2 or more episodes of vomiting per day on average for the 4 days prior to Day 14 or use of an NGT after Day 9 or use of an anticholinergic agent before Day 14 or withdrawal from the trial between Day 1 and Day 14 (included), whatever the cause.
Measured: Day 10 to Day 13
Secondary outcomes (10)
Number of Participants With Treatment Success From Day 5 to Day 7
Day 7 treatment success was defined as improvement of symptoms in the previous 2 days (average number of vomiting episodes less than 2 from Day 5, no Nasogastric Tube (NGT) since Day 5 and no anticholinergic agent or withdrawal from trial).
Measured: Day 5 to Day 7
Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14
The mean number of vomiting episodes per a 24 hour period is presented for Day 1, Day 7 and Day 14.
Measured: Day 1, Day 7 and Day 14
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1
Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 1.
Measured: Day 1
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7
Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 7.
Measured: Day 7
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14
Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 14.
Measured: Day 14
Number of Participants With Relief From Obstruction at Day 7 and Day 14
Relief from obstruction is defined by combining restart of stools for at least the previous 3 days, less than 2 episodes of vomiting on average for the previous 4 days and the restarting of flatus (gas generated in the stomach or bowels) for at least the previous 12 hours.
Measured: Day 7 and Day 14
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1
Recurrence of bowel obstruction was confirmed by abdominal X-ray.
Measured: 1 Month
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2
Recurrence of bowel obstruction was confirmed by abdominal X-ray.
Measured: Month 2
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3
Recurrence of bowel obstruction was confirmed by abdominal X-ray.
Measured: Month 3
Participant's Quality of Life Using the Edmonton Scale
The Edmonton Scale consisted of 9 items: pain, activity, nausea, depression, anxiety, fatigue, appetite, sensation of well-being and dyspnea (difficult or labored breathing). Participants rated these items on a scale of 0 to 10, with 10 being the worse.
Measured: Day 1, Day 7, Day 14, Month 1, Month 2 and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2006 (estimated)
- Study startSep 2005
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peritoneal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332696
- Sponsor's protocol ID
- CSMS995AFR08
- Status last verified
- Sep 2011
- First submitted
- 1 Jun 2006
- Last updated
- 23 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
- ClinicalTrials.gov ID
- NCT00332696
- Acronym / sponsor ID
- CSMS995AFR08
- Conditions
- Peritoneal Neoplasms, Intestinal Obstruction, Carcinomatosis
- Keywords
- bowel obstruction,, peritoneal carcinomatosis, Octreotide, inoperable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 2 Jun 2006 (estimated)
- Results
- Posted 15 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate in combination with corticosteroid and local standard medical care the efficacy and safety of long-acting octreotide compared to placebo for the treatment of symptoms of inoperable bowel obstruction in patients with peritoneal carcinomatosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Octreotide | Experimental | Drug: Octreotide LAR, Drug: Octreotide (Immediate release), Drug: methylprednisoloneParticipants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days. |
| Placebo | Placebo comparator | Drug: methylprednisolone, Drug: PlaceboParticipants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with symptoms and signs of inoperable bowel obstruction confirmed by a surgeon or clinic and radiographic assessment (CT scan or at least abdominal X-ray);
- Confirmed peritoneal carcinomatosis (with one of the following criteria : surgery, imaging and/or cytology);
- No corticotherapy at dose more than 1mg/kg equivalent-methylprednisolone, in the previous 2 weeks ;
- No chemotherapy in the previous week;
- No radio or chemotherapy planned at the inclusion and within the two weeks following inclusion
Key exclusion criteria (5 listed)
- Abnormal coagulation (prothrombin time < 60%, platelets < 50x10^9/L).
- Non authorized concomitant treatments :
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| Octreotide LARAlso: Sandostatin® LAROctreotide long-acting release (LAR) 30 mg intramuscular injection. | Drug | Octreotide |
| Octreotide (Immediate release)Also: Sandostatin®Immediate-release Octreotide supplied in 100 µg/mL ampules. | Drug | Octreotide |
| methylprednisolonemethlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections). | Drug | Octreotide, Placebo |
| PlaceboPhysiologic saline solution | Drug | Placebo |
Primary outcome
Number of Participants With Treatment Success From Day 10 to Day 13
Time frame: Day 10 to Day 13
Treatment Success was defined as: less than 2 episodes of vomiting on average per day for the 4 days prior to Day 14 [from Day 10 to Day 13] and no use of an Nasogastric Tube (NGT) since at least Day 10 and no use of an anticholinergic agent until Day 14. Treatment Failure is defined as: 2 or more episodes of vomiting per day on average for the 4 days prior to Day 14 or use of an NGT after Day 9 or use of an anticholinergic agent before Day 14 or withdrawal from the trial between Day 1 and Day 14 (included), whatever the cause.
10 secondary outcomes
Number of Participants With Treatment Success From Day 5 to Day 7
Time frame: Day 5 to Day 7
Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14
Time frame: Day 1, Day 7 and Day 14
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1
Time frame: Day 1
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7
Time frame: Day 7
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14
Time frame: Day 14
Number of Participants With Relief From Obstruction at Day 7 and Day 14
Time frame: Day 7 and Day 14
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1
Time frame: 1 Month
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2
Time frame: Month 2
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3
Time frame: Month 3
Participant's Quality of Life Using the Edmonton Scale
Time frame: Day 1, Day 7, Day 14, Month 1, Month 2 and Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 Octreotide LAR, Octreotide (Immediate release) and methylprednisolone in people with Peritoneal Neoplasms and Intestinal Obstruction, run by Novartis Pharmaceuticals 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 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 23 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 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?
Yes. Results are posted in the registry (first posted 15 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Treatment Success From Day 10 to Day 13 (time frame: Day 10 to Day 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2011; AzTrials last refreshed its copy on 7 Nov 2026.