CancerPhase 3NCT00635063
A Multicentre Study to Evaluate the Safety and Efficacy of AD 923 in Comparison to MSIR for the Treatment of CBP in Subjects
A Phase 3 study testing AD 923 in people with Cancer and Pain, run by Sosei at 1 site in United Kingdom.
Trial summary
Purpose: The purpose of this study is to compare the efficacy and safety of AD 923 to the most widely used current treatment (MSIR) in the management of target BTP in subjects with malignancies who are taking a stable dose of background opioids. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- AD 923
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2008to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- The subject is a male or female, at least 18 years of age.
- The subject has a malignancy, is receiving opioid therapy for his or her underlying persistent cancer pain, and is tolerant to the opioid therapy.
- The subject typically has 2 to 6 episodes of target BTP per day that require treatment.
- The subject has a life expectancy of >3 months.
- The subject or his or her caregiver has easy, reliable access to a telephone.
Main Exclusion Criteria:
- The subject is a female who is pregnant or lactating.
- The subject has any respiratory or cardiac condition that, in the opinion of the investigator, may be clinically worsened by opioids.
- The subject has any allergy to the AD 923 product or excipients, namely: fentanyl, dehydrated alcohol, menthol, saccharin, and citrate buffer; or to the MSIR product excipients, namely: morphine sulphate, lactose (anhydrous), pregelatinized maize starch, povidone, purified water, magnesium stearate, talc, and tablet coatings.
- The subject has any neurological or psychiatric disease that, in the opinion of the investigator, would compromise data collection.
- The subject has uncontrolled or rapidly escalating pain.
- The subject has any significant laboratory test results that, in the opinion of the investigator, will compromise subject safety or the conduct of the study.
- The subject has plans to undergo chemotherapy, radiotherapy, or surgery during the treatment period. The exception is that subjects may continue chemotherapy over the study period, provided it is not expected to alter the pain state or response to pain medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Randomised, Double-Blind, Double-Dummy, Crossover Study to Evaluate the Safety and Efficacy of AD 923 (Fentanyl Sublingual) in Comparison to Morphine Sulphate Immediate Release (MSIR) for the Treatment of Breakthrough Pain in Subjects With Malignancies
Purpose:
The purpose of this study is to compare the efficacy and safety of AD 923 to the most widely used current treatment (MSIR) in the management of target BTP in subjects with malignancies who are taking a stable dose of background opioids. The efficacy evaluation criteria have been designed to determine whether AD 923 provides superior analgesia compared with MSIR as measured by the primary endpoint.
- Being tested
- AD 923
- Keywords
- Cancer Breakthrough Pain
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD 923Drug
| Study group | Role | What they receive |
|---|---|---|
| AD 923 | Experimental | Not described Receives: Drug: AD 923 |
| MSIR | Active comparator | Not described Receives: Drug: AD 923 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of AD 923 in comparison to MSIR in the management of breakthrough pain in subjects with malignancies who are taking a stable dose of background opioids.
Secondary outcomes (1)
To assess the safety and tolerability of AD 923 in the management of breakthrough pain in subjects with malignancies who are taking a stable dose of background opioids.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startFeb 2008
Why it stopped: Termination is due to a combination of a device defect potentially impacting the quality of the AD 923 IMP and a major change in corporate strategy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sosei
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrew Davies, MBBS, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635063
- Sponsor's protocol ID
- P-AD923-005
- Status last verified
- Jun 2008
- First submitted
- 4 Mar 2008
- Last updated
- 6 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-Blind, Double-Dummy, Crossover Study to Evaluate the Safety and Efficacy of AD 923 (Fentanyl Sublingual) in Comparison to Morphine Sulphate Immediate Release (MSIR) for the Treatment of Breakthrough Pain in Subjects With Malignancies
- ClinicalTrials.gov ID
- NCT00635063
- Acronym / sponsor ID
- P-AD923-005
- Keywords
- Cancer Breakthrough Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termination is due to a combination of a device defect potentially impacting the quality of the AD 923 IMP and a major change in corporate strategy.
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- SoseiIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- First posted
- 13 Mar 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.
Purpose:
The purpose of this study is to compare the efficacy and safety of AD 923 to the most widely used current treatment (MSIR) in the management of target BTP in subjects with malignancies who are taking a stable dose of background opioids. The efficacy evaluation criteria have been designed to determine whether AD 923 provides superior analgesia compared with MSIR as measured by the primary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AD 923 | Experimental | Drug: AD 923 |
| MSIR | Active comparator | Drug: AD 923 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| AD 923 | Drug | AD 923, MSIR |
Primary outcome
To evaluate the efficacy of AD 923 in comparison to MSIR in the management of breakthrough pain in subjects with malignancies who are taking a stable dose of background opioids.
1 secondary outcome
To assess the safety and tolerability of AD 923 in the management of breakthrough pain in subjects with malignancies who are taking a stable dose of background opioids.
Results and safety
The study was stopped early (reason given: Termination is due to a combination of a device defect potentially impacting the quality of the AD 923 IMP and a major change in corporate strategy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2008.
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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.
Andrew Davies, MBBS principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AD 923 in people with Cancer and Pain, run by Sosei at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 6 Jun 2008. 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 United Kingdom. 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. 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 was stopped early (reason given: Termination is due to a combination of a device defect potentially impacting the quality of the AD 923 IMP and a major change in corporate strategy.). Results are not available in the source record.
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?
To evaluate the efficacy of AD 923 in comparison to MSIR in the management of breakthrough pain in subjects with malignancies who are taking a stable dose of background opioids.. 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 6 Jun 2008.