Postthoracotomy PainPhase 2BêtapainNCT01582646
Analgesic Effect of Beta 2-mimetics in the Treatment of Neuropathic Pain
A Phase 2 study testing Terbutaline sustained release 5 mg in people with Postthoracotomy Pain and Postthoracoscopy Neuropathic Pain, run by University Hospital, Strasbourg, France at 2 sites in France.
Trial summary
Neuropathic pain is due to a lesion or disease affecting the nervous system. Antidepressants (ADs) are recommended as the first line treatment. In a murine model, the investigators evidenced that antidepressants antiallodynic action is mediated through β2-adrenergic receptor stimulation and that β-mimetics display the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postthoracotomy Pain, Postthoracoscopy Neuropathic Pain
- What is being tested?
- Terbutaline sustained release 5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2012to Sep 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults from 18 to 75 years old
- neuropathic painful condition following a thoracotomy or thoracoscopy for at least 3 months
Who cannot join
- cardiovascular risk
- unstable diabetes mellitus
- allergy for terbutaline
- hypokaliemia without treatment
- untreated hypothyroidism
- HIV- or chemotherapy-induced neuropathy
Show all 9Show fewer
- cancer being treated by chemo- or radio-therapy
- concomitant treatment with β-blockers, tricyclic ADs or morphine
- concomitant pain more severe than neuropathic pain- pregnant women
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Besançon
Besançon, 25030
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Neuropathic pain is due to a lesion or disease affecting the nervous system. Antidepressants (ADs) are recommended as the first line treatment. In a murine model, the investigators evidenced that antidepressants antiallodynic action is mediated through β2-adrenergic receptor stimulation and that β-mimetics display the same effect. These data support the idea that β-mimetics could offer a therapeutic alternative to ADs for neuropathic pain treatment. This study will aim at assessing the effects of terbutaline on neuropathic pain symptoms.
- Being tested
- Terbutaline sustained release 5 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terbutaline sustained release 5 mgDrug
Terbutaline 10mg oral per day (5 mg twice a day) during 28 days
| Study group | Role | What they receive |
|---|---|---|
| first period with terbutaline and second period with placebo | Other | The studies will be randomized, double-blind, placebo-controlled. It will use a 4 + 4 weeks crossover design for terbutaline vs. placebo (no titration). A washout period (2 weeks) will separate the treatment periods. Receives: Drug: Terbutaline sustained release 5 mg |
| first period with placebo and second period with terbutaline. | Other | The studies will be randomized, double-blind, placebo-controlled. It will use a 4 + 4 weeks crossover design for terbutaline vs. placebo (no titration). A washout period (2 weeks) will separate the treatment periods. Receives: Drug: Terbutaline sustained release 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the average intensity of pain during the last 24 hours reported by the patient on a 11 points Numeric Scale
Measured: Day one, day 14 and day 28 of each 4 weeks period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2017
- Study completionSep 2017
Why it stopped: difficulty of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postthoracotomy PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- André Muller, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582646
- Sponsor's protocol ID
- 4705
- Acronym
- Bêtapain
- Status last verified
- Sep 2017
- First submitted
- 10 Apr 2012
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Beta 2-mimetics in the Treatment of Neuropathic Pain
- ClinicalTrials.gov ID
- NCT01582646
- Acronym / sponsor ID
- Bêtapain / 4705
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty of recruitment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 20 Apr 2012 (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.
Neuropathic pain is due to a lesion or disease affecting the nervous system. Antidepressants (ADs) are recommended as the first line treatment. In a murine model, the investigators evidenced that antidepressants antiallodynic action is mediated through β2-adrenergic receptor stimulation and that β-mimetics display the same effect. These data support the idea that β-mimetics could offer a therapeutic alternative to ADs for neuropathic pain treatment. This study will aim at assessing the effects of terbutaline on neuropathic pain symptoms.
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 |
|---|---|---|
| first period with terbutaline and second period with placebo | Other | Drug: Terbutaline sustained release 5 mgThe studies will be randomized, double-blind, placebo-controlled. It will use a 4 + 4 weeks crossover design for terbutaline vs. placebo (no titration). A washout period (2 weeks) will separate the treatment periods. |
| first period with placebo and second period with terbutaline. | Other | Drug: Terbutaline sustained release 5 mgThe studies will be randomized, double-blind, placebo-controlled. It will use a 4 + 4 weeks crossover design for terbutaline vs. placebo (no titration). A washout period (2 weeks) will separate the treatment periods. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults from 18 to 75 years old
- neuropathic painful condition following a thoracotomy or thoracoscopy for at least 3 months
Key exclusion criteria (9 listed)
- cardiovascular risk
- unstable diabetes mellitus
- allergy for terbutaline
- hypokaliemia without treatment
- untreated hypothyroidism
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 |
|---|---|---|
| Terbutaline sustained release 5 mgTerbutaline 10mg oral per day (5 mg twice a day) during 28 days | Drug | first period with placebo and second period with terbutaline., first period with terbutaline and second period with placebo |
Primary outcome
Change from baseline in the average intensity of pain during the last 24 hours reported by the patient on a 11 points Numeric Scale
Time frame: Day one, day 14 and day 28 of each 4 weeks period
Results and safety
The study was stopped early (reason given: difficulty of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
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.
André Muller, MD principal investigator
University Hospital, Strasbourg, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Terbutaline sustained release 5 mg in people with Postthoracotomy Pain and Postthoracoscopy Neuropathic Pain, run by University Hospital, Strasbourg, France at 2 sites 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 2 inclusion and 9 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: stopped early, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 was stopped early (reason given: difficulty of recruitment). 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?
Change from baseline in the average intensity of pain during the last 24 hours reported by the patient on a 11 points Numeric Scale (time frame: Day one, day 14 and day 28 of each 4 weeks period). 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 11 Sep 2017.