Must make our own Phase 2 study; 8 pages and come up with a introduction, selection and withdrawal of subjects, assessment of safety and analysis

Study Enrollment and Withdrawal

5.1 Inclusion Criteria

To be included in the trial, patients must fulfill the following criteria:

1. Written consent to participate in the study

2. Subjects must be at least 18 years old

3. Symptoms consistent with pain within the past 6 months

4. Male and females’ subjects are eligible. If female, subject must be not of childbearing potential.

5. If female and of childbearing potential, subject must be non-lactating and non-pregnant.

6. Subjects must have body weight of 45 kg

7. Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions.

8. Patients must be healthy

5.2 Exclusion criteria

Patients fulfilling at least one of the following criteria may not be included in the study:

Disease-related criteria

1. History of gastritis, peptic ulcer disease, gastroesophageal reflux disease, ulcerative colitis, or another inflammatory bowel disease

2. History of bleeding disorder

3. History of acute or chronic hepatic disease

4. History of congestive heart failure

5. History of renal insufficiency or failure

Previous or concomitant treatment related criteria

1. Treatment with glucocorticoids in the past 2 weeks

2. Having already taken some form of analgesia, including acetaminophen, non-steroidal ani-inflammatory drug (NSAIDs), or opioid or nonopioid pain relivers

Patient-related criteria

3. Active substance abuse (drugs or alcohol) or history of substance abuse within the past 12 months.

4. Females who are pregnant or nursing or planning to become pregnant during the study; men who plan to conceive during the study.

5. Any clinically significant acute or chronic medical conditions, that would limit the patient’s ability to complete the study and/or compromise the objective of the study.

5.3 Strategies for Recruitment and Retention

A maximum of 75 patients that meet the inclusion criteria may enrolled in each protocol. A total of 2 groups, for a total of 150 people.

5.4 Patient withdrawal or Termination

Each treated patient in this study receives the study medication in a three-dose series (every 12 hours). Patient shall be informed of their right to discontinue from the study at any time and for any reason. If the patient does decide to leave the trial at any time, the lead investigator must:

· Document in the patient’s reason and timing of discontinuation

· Document if the patient experienced any adverse effect when leaving study.

5.5 Subject compensation

As per the rule, the financial compensation the patients will be entitled to finical compensation.

In case of clinical trial related death, the patients will be entitled to finical compensation will be over and above the expense incurred on the medical management of the trial subject.