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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02982161
Date of registration: 25/11/2016
Prospective Registration: Yes
Primary sponsor: Mundipharma Research GmbH & Co KG
Public title: Efficacy and Safety in a Randomised Acute Pain Study of MR308 (Tramadol/Celecoxib). STARDOM1
Scientific 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 Third Molar Tooth Extraction (STARDOM1).
Date of first enrolment: December 28, 2016
Target sample size: 818
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02982161
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).  
Phase:  Phase 3
Countries of recruitment
Canada France Germany Hungary Italy Japan Poland Spain
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male/female subjects = 18 years on the day of consent.

2. Willing and able to provide written informed consent for this study.

3. Subjects must have a planned elective dental procedure i.e. extraction of at least two
impacted third molars (one of them must be mandibular) requiring bone removal, within
28 days after the Screening Visit. If only two impacted third molars are extracted,
they must be ipsilateral and require bone removal.

4. 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).

5. Good general health as judged by Investigators on the basis of medical history and
physical examination.

6. Willingness to comply with the study procedures and requirements.

Additional Inclusion Criteria after Surgery:

1. Third molar extractions completed without any immediate complication.

2. Tolerating oral fluids, no uncontrolled nausea/vomiting and ready to take oral
analgesia.

3. The subject is alert and calm, spontaneously pays attention to caregiver, e.g. RASS =
0 (Sessler et al., 2002 & Ely et al., 2003).

4. Subjects with moderate or severe pain (qualifying PI-VAS score = 45mm and < 70mm or =
70mm) as a result of an oral surgical procedure under local anaesthesia and/or
sedation*. This must be measured within a maximum of 6 hours after the end of the
surgical procedure.

Exclusion Criteria:

1. Any abnormal laboratory value that is clinically significant in the opinion of
Investigator that would compromise the safety of the subject in the study.

2. Any recent history of frequent nausea or vomiting, dizziness within the last 3 months
regardless of etiology.

3. 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.

4. 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.

5. Subjects who are known to have had inadequate pain relief from paracetamol, tramadol
or celecoxib.

6. Subjects requiring any medication which is prohibited as per section prohibited
medication.

7. Subjects who are in the Investigators opinion considered at increased risk of
post-operative complications e.g. major dental infection/abscess.

8. 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.

9. Significant neurological or psychiatric disorders including mental instability
(unrelated to the pain) that could interfere with pain assessment; other pain that
might impair the assessment of the nociceptive pain.

10. 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.

11. Previous randomisation in this study.

12. 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).

13. 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.

14. Subjects who have received any analgesic medication (e.g. NSAIDs, oral opioid
preparations etc.) other than short-acting preoperative or intraoperative local
anaesthetic agents within 12 hours before the start of the surgery or peri operatively
until randomisation.

15. Subjects who are incapable of complying with the protocol.

Additional Exclusion Criteria after Surgery:

1. Serious complication during surgery and up to randomisation, including:

- Post-operative primary and secondary bleed that cannot be controlled.

- Subjects who did not had the third molar extraction completed as planned.

2. Post-operative medications or treatments that can have an analgesic effect or cause
sedation or have amnesic effect are not permitted as these may interfere with the
study assessments. These include use of ice packs, corticosteroids, nitrous oxide,
benzodiazepines, alcohol, hypnotics, analgesics, opioids, other psychotropic medicinal
products and any other analgesia except the provided study treatments

3. If in the Investigators opinion there are any factors that may confound the analysis
of the study regarding efficacy and safety (e.g. a PI-VAS score greater than 90).



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Acute Pain
Intervention(s)
Drug: MR308
Drug: Placebo
Drug: Tramadol
Primary Outcome(s)
Efficacy of MR308 doses in the treatment of moderate to severe acute pain, based on the Sum of Pain Intensity Differences (SPID). [Time Frame: 0-4 hours]
Secondary Outcome(s)
Secondary ID(s)
MR308-3501
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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