Acute PainPhase 3STARDOM2NCT03062644
Efficacy and Safety in a Randomised Acute Pain Study of MR308: STARDOM2.
A Phase 3 study testing MR308 in people with Acute Pain, run by Mundipharma Research GmbH & Co KG at 8 sites in 8 countries.
Trial summary
The MR308-3502 study is a multicenter double-blind, randomised, placebo- and active comparator-controlled study in female subjects to evaluate the efficacy and safety of MR308 with acute pain after TAH or STAH (total or subtotal abdominal hysterectomy). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Acute Pain
- What is being tested?
- MR308
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,138 participants
- Where
- 8 sitesin 8 countries
- Study dates
- 5 Apr 2017to 29 Jun 2018
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects ≥ 18 years on the day of consent.
- Willing and able to provide written informed consent for this study.
- Subjects are scheduled to have a total or subtotal abdominal hysterectomy under general anasethesia via a Pfannenstiel incision.
- The elective procedure (total or subtotal hysterectomy with or without salpingo-oophorectomy) must be for benign conditions within 28 days of screening. Subjects with stage 0 carcinoma in situ of cervix, endometrial hyperplasia or clinically staged 1A or 1B endometrial cancer are allowed to participate.
- American Society Anaesthesiology physical status of I or II.
- If a female is of child-bearing potential, she must be using highly effective methods of contraception throughout the study, not breastfeeding, and have negative pregnancy tests prior to receiving IMP. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner).
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- Good general health as judged by Investigators on the basis of medical history and physical examination.
- Willingness to comply with the study procedures and requirements.
- Additional Inclusion Criteria after Surgery:
- Abdominal hysterectomy completed without any immediate complication.
- Tolerating oral fluids, no uncontrolled nausea/vomiting and ready to take oral analgesia.
- The subject is alert and calm, spontaneously pays attention to caregiver, e.g. RASS = 0 (Sessler et al., 2002 \& Ely et al., 2003).
- Subjects will be capable to sit up from supine, stand up from a sitting position and walk 10 meters without assistance in the morning of the day following surgery.
- Subjects with moderate or severe pain (qualifying PI-VAS score ≥ 45mm and < 70mm or ≥ 70mm and ≤ 90mm) as a result of a surgical procedure (abdominal hysterectomy) under general anaesthesia. This must be measured within a maximum of 24 hours after leaving the recovery room and subjects can only be randomised on the day after surgery, after cessation of the post-operative analgesia.
Who cannot join
- Any abnormal laboratory value that is clinically significant in the opinion of Investigator that would compromise the safety of the subject in the study.
- Any recent history of frequent nausea or vomiting, dizziness within the last 3 months regardless of etiology.
- Subjects having any medical condition or treatment that is either a warning or contraindication as per the SmPC of tramadol (e.g. selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, MAO inhibitors (within 14 days before taking IMP), antipsychotics, anticonvulsant and other seizure threshold-lowering medicinal products), celecoxib (e.g. increased risk of post-operative bleeding, active peptic ulceration, GI bleeding or inflammatory bowel disease) or paracetamol.
- Known sensitivity and/or contraindication to tramadol, celecoxib, paracetamol, sulfonamides, opioids, NSAIDS, COX-2 inhibitors, or related compounds or formulation excipients as well as severe hypersensitivity reactions (e.g. anaphylactic shock, bronchospasm, angioedema) to any drugs.
- Subjects who are known to have had inadequate pain relief from paracetamol, tramadol or celecoxib.
- Subjects requiring any medication which is prohibited as per section prohibited medication.
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- Subjects who are in the Investigator's opinion considered at increased risk of operative (those associated with the surgical procedure and general anaesthesia) and post-operative complications, e.g. excessive post-operative bleeding, infection.
- Any history of drug or alcohol abuse, misuse, physical or psychological dependence, mood changes, sleep disturbance and functional capacity which have an impact on pain perception.
- Significant neurological or psychiatric disorders including mental instability (unrelated to the pain) that could interfere with pain assessment; other pre-existing or new non-abdominal/pelvic pain that might impair the assessment of the nociceptive pain.
- Any medical history of significant and/or inadequately controlled cardiovascular (uncontrolled high blood pressure, high risk of cardiovascular events, severe heart failure), pulmonary, hematologic, (including coagulopathy/bleeding disorders), neurological (e.g. subjects with epilepsy or those susceptible to seizures), liver disease (e.g. severe hepatic impairment), kidney disease (e.g. serum creatinine level greater than 1.5 times the upper limit of normal, impaired renal function in subjects taking diuretics, ACE-inhibitors, or angiotensin II antagonists), endocrine, immunologic, dermatologic painful conditions or any other conditions that may compromise the ability of the subject to participate in the study or might interfere with drug absorption, distribution, metabolism or excretion.
- Previous randomisation in this study.
- Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days of study entry (defined as the start of the Screening Period).
- Subjects who were treated regularly with opioid analgesic or NSAIDs within 30 days prior to screening or who have received a long-acting NSAID within three days prior to the start of the surgery.
- Subjects who are incapable of complying with the protocol.
- Epidural or spinal anaesthesia or infiltration of the wound with an infusion of a local anaesthetic agent is not allowed. A single perioperative dose is allowed.
- History or ongoing chronic pelvic inflammatory disease or painful endometriosis.
- History of advanced gynaecological cancers.
- Additional Exclusion Criteria after Surgery:
- Serious complication during surgery and up to randomisation, including:
- Post-operative primary and secondary bleed that cannot be controlled.
- Subjects who have not had the abdominal hysterectomy surgery completed as planned.
- If in the Investigator's opinion, there are any factors that may affect compliance with the protocol.
- Subject clinical need for antiemetics (apart from standard perioperative practice as defined in the protocol) or any other medication which is prohibited as per section prohibited medication.
- Subjects who have received any analgesic medication other than perioperative analgesia as described in the protocol.
- Any concerns that renal function has deteriorated, e.g. a laboratory parameter, profound hypotension, poor urine output or excessive bleeding during surgery.
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
Belarus1 site
Minsk City Gynecology Hospital Department of Gynecology
Minsk, 220007
Bulgaria1 site
"Multiprofile Hospital for Active Treatment - Doverie" AD, Sofia Department of Gynecology
Sofia, 1632
Canada1 site
Victoria Hospital - London Health Sciences Centre
London, Ontario, N6A 5W9
Hungary1 site
Bajcsy-Zsilinszky Korhaz Szuleszet-Nogyogyaszati Osztaly
Budapest, 1106
Latvia1 site
Vidzeme Hospital Department of Gynecology and Obstetrics
Valmiera, 4201
Poland1 site
Wojewódzki Szpital im. Św. Ojca Pio w Przemyślu Oddział Ginekologii i Położnictwa
Przemyśl, 37-700
Russia1 site
Federal State Budgetary Institution National Medical-Surgical Centre named after N.I. Pirogov of the Ministry of Health of the Russian Federation Anesthesiology
Moscow, 105203
Spain1 site
Hospital Universitari Germans Trias i Pujol Anestesia y Reanimación
Barcelona, 08916
About this study
Official title: A Randomized, Double-Blind, Multicenter, Placebo- and Active Comparator-Controlled Study to Evaluate Efficacy and Safety of MR308 in the Treatment of Acute Pain After Abdominal Hysterectomy Surgery Under General Anaesthesia (STARDOM2).
The MR308-3502 study is a multicenter double-blind, randomised, placebo- and active comparator-controlled study in female subjects to evaluate the efficacy and safety of MR308 with acute pain after TAH or STAH (total or subtotal abdominal hysterectomy).
Read the detailed description
This is a multicenter double-blind, randomised, placebo- and active comparator-controlled study in female subjects to evaluate the efficacy and safety of MR308 with acute pain after total or subtotal abdominal hysterectomy (TAH or STAH).
The screening Visit (Visit 1) can take place up to 28 days before the planned TAH or STAH. The surgery will be performed at Visit 2. Visit 2 consists of three different sections, a part before the surgery, the surgery and post surgery. On the next Day (Visit 3) subjects will qualify for further participation by regular measurements of their pain. Subjects meeting all eligibility criteria, such as defined pain levels, will be randomised to one of six treatment groups and be given IMPs for 120h. Subjects who will not be randomised are screen failures and will be given standard care as per local practice.
Visits 4, 5, 6 ,7 and 8, one to five days after randomisation will be performed to record efficacy and safety parameters.
The last dose of IMP should be taken by the subject about 120h after the initial dose and before Visit 8 (Completion/Discontinuation Visit) is performed.
The Adverse Event (AE) Follow up Visit (Visit 9) is the last study visit and should not be done earlier than seven days after the subject's last dose of IMP. It can be performed by telephone.
- Conditions
- Acute Pain
- Being tested
- MR308
- Keywords
- Open Total or Subtotal Abdominal Hysterectomy
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR308Drug
Also called Tramadol/Celecoxib
two times daily; Mode of Administration:oral
MR308Drug
Also called Tramadol
four times daily; Mode of Administration:oral
MR308Drug
Also called Celecoxib
two times daily; Mode of Administration:oral
MR308Drug
Also called Placebos
given four times daily to maintain the blind; Mode of Administration:oral
| Study group | Role | What they receive |
|---|---|---|
| MR308 100 mg bid | Experimental | Tramadol/Celecoxib) Receives: Drug: MR308 |
| MR308 150 mg bid | Experimental | Tramadol/Celecoxib Receives: Drug: MR308 |
| MR308 200 mg bid | Experimental | Tramadol/Celecoxib Receives: Drug: MR308 |
| Tramadol 100 mg qid | Active comparator | Tramadol Receives: Drug: MR308 |
| Celecoxib 100 mg bid | Active comparator | Celecoxib Receives: Drug: MR308 |
| Placebo | Placebo comparator | Placebo Receives: Drug: MR308 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of MR308 doses in the treatment of moderate to severe acute pain, based on the Sum of Pain Intensity Differences (SPID) from 0-4 hours.
The primary efficacy endpoint is the Sum of Pain Intensity Differences over 0-4 hours (SPID4). SPID4 is derived as the weighted Sum of Pain Intensity Differences (baseline pain - current pain), measured at different time points via the PI-VAS. Time between two consecutive measurements will be used for weighting. Larger values indicate larger pain relief.
Measured: 0-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start5 Apr 2017
- Primary completion29 Jun 2018
- Study completion29 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Research GmbH & Co KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062644
- Sponsor's protocol ID
- MR308-3502
- Acronym
- STARDOM2
- Status last verified
- Sep 2018
- First submitted
- 20 Feb 2017
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Viscusi ER, Langford R, Morte A, Vaque A, Cebrecos J, Sust M, Gimenez-Arnau JM, de Leon-Casasola O. Safety of Co-Crystal of Tramadol-Celecoxib (CTC) in Patients with Acute Moderate-to-Severe Pain: Pooled Analysis of Three Phase 3 Randomized Trials. Pain Ther. 2024 Dec;13(6):1617-1631. doi: 10.1007/s40122-024-00655-w. Epub 2024 Sep 24.
PubMed 39316284Langford R, Morte A, Sust M, Cebrecos J, Vaque A, Ortiz E, Fettiplace J, Adeyemi S, Raba G, But-Husaim L, Gascon N, Plata-Salaman C. Efficacy and safety of co-crystal of tramadol-celecoxib (CTC) in acute moderate-to-severe pain after abdominal hysterectomy: A randomized, double-blind, phase 3 trial (STARDOM2). Eur J Pain. 2022 Nov;26(10):2083-2096. doi: 10.1002/ejp.2021. Epub 2022 Sep 24.
PubMed 35974668
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multicenter, Placebo- and Active Comparator-Controlled Study to Evaluate Efficacy and Safety of MR308 in the Treatment of Acute Pain After Abdominal Hysterectomy Surgery Under General Anaesthesia (STARDOM2).
- ClinicalTrials.gov ID
- NCT03062644
- Acronym / sponsor ID
- STARDOM2 / MR308-3502
- Conditions
- Acute Pain
- Keywords
- Open Total or Subtotal Abdominal Hysterectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,138 participants (actual)
- Lead sponsor
- Mundipharma Research GmbH & Co KGIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 23 Feb 2017 (actual)
- 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.
The MR308-3502 study is a multicenter double-blind, randomised, placebo- and active comparator-controlled study in female subjects to evaluate the efficacy and safety of MR308 with acute pain after TAH or STAH (total or subtotal abdominal hysterectomy).
Detailed description
This is a multicenter double-blind, randomised, placebo- and active comparator-controlled study in female subjects to evaluate the efficacy and safety of MR308 with acute pain after total or subtotal abdominal hysterectomy (TAH or STAH).
The screening Visit (Visit 1) can take place up to 28 days before the planned TAH or STAH. The surgery will be performed at Visit 2. Visit 2 consists of three different sections, a part before the surgery, the surgery and post surgery. On the next Day (Visit 3) subjects will qualify for further participation by regular measurements of their pain. Subjects meeting all eligibility criteria, such as defined pain levels, will be randomised to one of six treatment groups and be given IMPs for 120h. Subjects who will not be randomised are screen failures and will be given standard care as per local practice.
Visits 4, 5, 6 ,7 and 8, one to five days after randomisation will be performed to record efficacy and safety parameters.
The last dose of IMP should be taken by the subject about 120h after the initial dose and before Visit 8 (Completion/Discontinuation Visit) is performed.
The Adverse Event (AE) Follow up Visit (Visit 9) is the last study visit and should not be done earlier than seven days after the subject's last dose of IMP. It can be performed by telephone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MR308 100 mg bid | Experimental | Drug: MR308Tramadol/Celecoxib) |
| MR308 150 mg bid | Experimental | Drug: MR308Tramadol/Celecoxib |
| MR308 200 mg bid | Experimental | Drug: MR308Tramadol/Celecoxib |
| Tramadol 100 mg qid | Active comparator | Drug: MR308Tramadol |
| Celecoxib 100 mg bid | Active comparator | Drug: MR308Celecoxib |
| Placebo | Placebo comparator | Drug: MR308Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Female subjects ≥ 18 years on the day of consent.
- Willing and able to provide written informed consent for this study.
- Subjects are scheduled to have a total or subtotal abdominal hysterectomy under general anasethesia via a Pfannenstiel incision.
- The elective procedure (total or subtotal hysterectomy with or without salpingo-oophorectomy) must be for benign conditions within 28 days of screening. Subjects with stage 0 carcinoma in situ of cervix, endometrial hyperplasia or clinically staged 1A or 1B endometrial cancer are allowed to participate.
- American Society Anaesthesiology physical status of I or II.
Key exclusion criteria (25 listed)
- Any abnormal laboratory value that is clinically significant in the opinion of Investigator that would compromise the safety of the subject in the study.
- Any recent history of frequent nausea or vomiting, dizziness within the last 3 months regardless of etiology.
- Subjects having any medical condition or treatment that is either a warning or contraindication as per the SmPC of tramadol (e.g. selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, MAO inhibitors (within 14 days before taking IMP), antipsychotics, anticonvulsant and other seizure threshold-lowering medicinal products), celecoxib (e.g. increased risk of post-operative bleeding, active peptic ulceration, GI bleeding or inflammatory bowel disease) or paracetamol.
- Known sensitivity and/or contraindication to tramadol, celecoxib, paracetamol, sulfonamides, opioids, NSAIDS, COX-2 inhibitors, or related compounds or formulation excipients as well as severe hypersensitivity reactions (e.g. anaphylactic shock, bronchospasm, angioedema) to any drugs.
- Subjects who are known to have had inadequate pain relief from paracetamol, tramadol or celecoxib.
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 |
|---|---|---|
| MR308Also: Tramadol/Celecoxibtwo times daily; Mode of Administration:oral | Drug | MR308 100 mg bid, MR308 150 mg bid, MR308 200 mg bid |
| MR308Also: Tramadolfour times daily; Mode of Administration:oral | Drug | Tramadol 100 mg qid |
| MR308Also: Celecoxibtwo times daily; Mode of Administration:oral | Drug | Celecoxib 100 mg bid |
| MR308Also: Placebosgiven four times daily to maintain the blind; Mode of Administration:oral | Drug | Placebo |
Primary outcome
Efficacy of MR308 doses in the treatment of moderate to severe acute pain, based on the Sum of Pain Intensity Differences (SPID) from 0-4 hours.
Time frame: 0-4 hours
The primary efficacy endpoint is the Sum of Pain Intensity Differences over 0-4 hours (SPID4). SPID4 is derived as the weighted Sum of Pain Intensity Differences (baseline pain - current pain), measured at different time points via the PI-VAS. Time between two consecutive measurements will be used for weighting. Larger values indicate larger pain relief.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Derived from this study: PubMed 39316284Viscusi ER, Langford R, Morte A, Vaque A, Cebrecos J, Sust M, Gimenez-Arnau JM, de Leon-Casasola O. Safety of Co-Crystal of Tramadol-Celecoxib (CTC) in Patients with Acute Moderate-to-Severe Pain: Pooled Analysis of Three Phase 3 Randomized Trials. Pain Ther. 2024 Dec;13(6):1617-1631. doi: 10.1007/s40122-024-00655-w. Epub 2024 Sep 24.
- Derived from this study: PubMed 35974668Langford R, Morte A, Sust M, Cebrecos J, Vaque A, Ortiz E, Fettiplace J, Adeyemi S, Raba G, But-Husaim L, Gascon N, Plata-Salaman C. Efficacy and safety of co-crystal of tramadol-celecoxib (CTC) in acute moderate-to-severe pain after abdominal hysterectomy: A randomized, double-blind, phase 3 trial (STARDOM2). Eur J Pain. 2022 Nov;26(10):2083-2096. doi: 10.1002/ejp.2021. Epub 2022 Sep 24.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MR308 in people with Acute Pain, run by Mundipharma Research GmbH & Co KG at 8 sites in 8 countries.
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 14 inclusion and 25 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 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belarus, Bulgaria, Canada, Hungary, Latvia and 3 more countries. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy of MR308 doses in the treatment of moderate to severe acute pain, based on the Sum of Pain Intensity Differences (SPID) from 0-4 hours. (time frame: 0-4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03062644, which also lists 2 linked publications.
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 20 Sep 2018.